Acute Coronary SyndromePhase 3PLATONCT00391872

A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome

A Phase 3 study testing Ticagrelor and Clopidogrel in people with Acute Coronary Syndrome, run by AstraZeneca at 672 sites in 44 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: Ticagrelor and Clopidogrel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18,624 participants
Where: 672 sitesin 44 countries
Study dates: Oct 2006to Mar 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception

Who cannot join

Persons with moderate or severe liver disease
Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
Persons who are being treated with blood clotting agents that cannot be stopped

Trial locations and contacts

672 sites in 44 countries.

Country

City, postcode or hospital

672 sites in 44 countries

United States139 sites

Research Site
Albuquerque, New Mexico
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Amarillo, Texas
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Anderson, South Carolina
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Ann Arbor, Michigan
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Ashland, Kentucky
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Atlantis, Florida
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Auburn, Maine
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Austin, Texas
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Bakersfield, California
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Baltimore, Maryland
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Bangor, Maine
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Bend, Oregon
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Bethesda, Maryland
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Beverly Hills, California
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Birmingham, Alabama
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Boston, Massachusetts
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Brooklyn, New York
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Buffalo, New York
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Burbank, California
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Burlington, Vermont
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Camp Hill, Pennsylvania
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Chapel Hill, North Carolina
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Charleston, South Carolina
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Charlotte, North Carolina
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Chicago, Illinois
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Cleveland, Ohio
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Columbia, Missouri
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Columbia, South Carolina
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Columbus, Ohio
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Dallas, Texas
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Danbury, Connecticut
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Danville, Pennsylvania
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Daytona Beach, Florida
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Doylestown, Pennsylvania
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Duluth, Minnesota
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Everett, Washington
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Falls Church, Virginia
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Fort Collins, Colorado
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Fort Lauderdale, Florida
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Fredericksburg, Virginia
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Green Bay, Wisconsin
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Greensboro, North Carolina
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Greenville, South Carolina
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Harrisburg, Pennsylvania
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Hartford, Connecticut
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Healdsburg, California
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High Point, North Carolina
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Hollywood, Florida
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Houston, Texas
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Huntsville, Alabama
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Indianapolis, Indiana
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Iowa City, Iowa
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Jackson, Tennessee
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Jacksonville, Florida
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Johnson City, New York
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Joplin, Missouri
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Jupiter, Florida
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Kalamazoo, Michigan
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Kansas City, Kansas
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Kansas City, Missouri
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Kettering, Ohio
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Kingston, New York
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Knoxville, Tennessee
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Lancaster, Pennsylvania
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Langhorne, Pennsylvania
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Lansing, Michigan
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Laper, Michigan
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Lincoln, Nebraska
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Los Angeles, California
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Louisville, Kentucky
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Lubbock, Texas
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Melbourne, Florida
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Memphis, Tennessee
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Miami Beach, Florida
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Minneapolis, Minnesota
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Mobile, Alabama
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Morgantown, West Virginia
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Muncie, Indiana
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New Hartford, New York
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New York, New York
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Newark, Delaware
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Newark, New Jersey
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Norfolk, Virginia
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Oakland, New Jersey
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Ocala, Florida
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Oklahoma City, Oklahoma
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Olathe, Kansas
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Omaha, Nebraska
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Orlando, Florida
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Ormond Beach, Florida
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Papillion, Nebraska
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Park Ridge, Illinois
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Paterson, New Jersey
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Pensacola, Florida
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Philadelphia, Pennsylvania
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Pittsburgh, Pennsylvania
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Pontiac, Michigan
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Providence, Rhode Island
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Raleigh, North Carolina
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Rapid City, South Dakota
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Rochester, New York
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Rock Island, Illinois
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Rockford, Illinois
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Roseville, California
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Royal Oak, Michigan
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Sacramento, California
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Saginaw, Michigan
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Saint Paul, Minnesota
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Salisbury, Maryland
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San Antonio, Texas
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San Diego, California
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San Marcos, Texas
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Sarasota, Florida
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Sayre, Pennsylvania
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Sellersville, Pennsylvania
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Shreveport, Louisiana
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Springfield, Massachusetts
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St Louis, Missouri
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St. Petersburg, Florida
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Syracuse, New York
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Tacoma, Washington
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Torrance, California
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Troy, Michigan
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Tucson, Arizona
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Tulsa, Oklahoma
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Tupelo, Mississippi
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Tyler, Texas
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Valparaiso, Indiana
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Victoria, Texas
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Wakefield, Rhode Island
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Washington D.C., District of Columbia
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West Des Moines, Iowa
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Williamsville, New York
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Winchester, Virginia
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Winston-Salem, North Carolina
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Wormleysburg, Pennsylvania
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York, Pennsylvania
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Ypsilanti, Michigan
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Zanesville, Ohio

Other trials in United States

Germany39 sites

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Aschaffenburg
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Bad Mergentheim
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Bad Nauheim
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Bad Rothenfelde
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Berlin
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Bochum
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Bonn
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Cloppenburg
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Coburg
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Dortmund
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Dresden
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Duisburg
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Erfurt
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Essen
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Esslingen am Neckar
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Frankfurt
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Göttingen
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Greifswald
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Halle
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Hamburg
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Hanover
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Heidelberg
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Jena
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Kiel
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Krefeld
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Limburg
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Lübeck
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Mainz
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Merseburg
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Mönchengladbach
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Muhlheim An Der Ruhr
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Münster
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Regensburg
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Rostock
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Ulm
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Warendorf
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Witten
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Wuppertal
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Würzburg

Other trials in Germany

Netherlands36 sites

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Alkmaar
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Almelo
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Amersfoort
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Amsterdam
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Apeldoorn
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Arnhem
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Assen
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Blaricum
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Breda
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Capelle aan den IJssel
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Delft
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Deventer
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Dordrecht
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Drachten
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Ede
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Eindhoven
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Goes
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Gorinchem
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Gouda
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Haarlem
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Hardenberg
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Harderwijk
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Heerlen
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Helmond
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Hilversum
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Leeuwarden
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Maastricht
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Nieuwegein
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Nijmegen
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Rotterdam
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Spijkenisse
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The Hague
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Tiel
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Tilburg
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Veldhoven
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Vlaardingen

Other trials in Netherlands

France34 sites

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Abbeville
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Allauch
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Arras
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Avignon
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Bayonne
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Besançon
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Brest
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Caen
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Cholet
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Créteil
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Croix
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Dijon
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Douai
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Falaise
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Fréjus
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La Rochelle
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Lagny-sur-Marne
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Lille
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Limoges
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Lomme
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Marseille
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Nîmes
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Orléans
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Paris
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Pau
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Pessac
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Quincy-sous-Sénart
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Rennes
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Rouen
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Senlis
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Strasbourg
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Toulouse
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Tourcoing
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Valenciennes

Other trials in France

Poland30 sites

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Bialystok
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Bielsko-Biala
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Bydgoszcz
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Bytom
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Częstochowa
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Elblag
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Gda?sk
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Gdynia
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Grodzisk Mazowiecki
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Inowrocław
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Katowice
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Krakow
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Lodz
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Lublin
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Oława
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Olsztyn
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Opole
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Ostrowiec Świętokrzyski
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Płock
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Poznan
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Radom
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Szczecin
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Tarnów
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Torun
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Wałbrzych
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Warsaw
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Wejherowo
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Włocławek
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Wroclaw
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Zamość

Other trials in Poland

Italy29 sites

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Ancona, AN
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Bagno a Ripoli, FI
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Bari, BA
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Bergamo, BG
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Caserta, CE
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Catania, CT
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Ferrara, FE
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Florence, FI
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Foggia, FG
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Legnano, MI
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Lido di Ostia, Roma
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Mantua, MN
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Massa Carrara
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Mestre, VE
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Milan, MI
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Modena, MO
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Monza, MI
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Naples
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Novara
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Parma, PR
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Pavia, PV
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Pescara, PE
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Roma
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Rozzano, MI
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San Giovanni Rotondo, FG
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Sassari, SS
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Treviso, TV
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Varese, VA
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Verona, VR

Other trials in Italy

Canada28 sites

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Brockville, Ontario
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Calgary, Alberta
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Cambridge, Ontario
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Campbell River, British Columbia
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Cornwall, Ontario
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Edmonton, Alberta
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Kelowna, British Columbia
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Laval, Quebec
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London, Ontario
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Montreal, Quebec
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New Westminster, British Columbia
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Newmarket, Ontario
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Oshawa, Ontario
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Ottawa, Ontario
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Penticton, British Columbia
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Québec, Quebec
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Regina, Saskatchewan
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Saint John, New Brunswick
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Saint-Georges, Quebec
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Scarborough Village, Ontario
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Sherbrooke, Quebec
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St. John's, Newfoundland and Labrador
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Surrey, British Columbia
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Thetford-Mines, Quebec
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Toronto, Ontario
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Vancouver, British Columbia
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Victoria, British Columbia
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Winnipeg, Manitoba

Other trials in Canada

Denmark22 sites

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Copenhagen
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Esbjerg
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Fredericia
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Frederiksberg
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Frederikssund
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Glostrup Municipality
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Hellerup
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Herlev
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Herning
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Hillerød
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Hjørring
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Holbæk
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Horsens
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Hvidovre
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Køge
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Kolding
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Næstved
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Odense C
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Roskilde
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Silkeborg
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Slagelse
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Viborg

Other trials in Denmark

Russia19 sites

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Barnaul
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Irkutsk
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Kaliningrad
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Kazan'
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Kemerovo
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Khanty-Mansiysk, Khanty-mansiysk Autonomous Dis
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Krasnodar
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Krasnoyarsk
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Moscow
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Murmansk
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Nizhny Novgorod
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Novosibirsk
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Rostov-on-Don
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Saint Petersburg
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Samara
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Tomsk
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Tyumen
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Vladivostok
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Yekaterinburg

Other trials in Russia

Brazil18 sites

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Aracaju, Sergipe
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Belo Horizonte, Minas Gerais
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Brasília, Federal District
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Campinas
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Campo Grande, Mato Grosso do Sul
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Curitiba, Paraná
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Goiânia, Goiás
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Maceió, Alagoas
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Maringá, Paraná
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Natal, Rio Grande do Norte
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Porto Alegre, Rio Grande do Sul
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Recife, Pernambuco
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Rio de Janeiro, Rio de Janeiro
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S.j.rio Preto, São Paulo
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Salvador, Estado de Bahia
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São José, Santa Catarina
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São Paulo, São Paulo
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Uberlândia, Minas Gerais

Other trials in Brazil

India18 sites

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Ahmedabad, Gujarat
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Bangalore, Karnataka
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Bhopal, Madhya Pradesh
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Bikaner, Rajasthan
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Chennai, Tamil Nadu
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Coimabatore, Tamil Nadu
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Gandhinagar, Gujarat
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Hyderabad, Andhrapradesh
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Jaipur, Rajasthan
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Kochi, Kerala
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Kolkata, West Bengal
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Mumbai, Maharashtra
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Nagpur, Maharashtra
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New Delhi, National Capital Territory of Delhi
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Patiāla, Punjab
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Thrissur, Kerala
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Vadodara, Gujarat
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Vijayawada, Andhrapradesh

Other trials in India

Sweden18 sites

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Borås
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Eksjö
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Eskilstuna
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Falun
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Halmstad
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Jönköping
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Kalmar
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Karlskrona
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Lidköping
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Linköping
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Ljungby
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Lund
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Östersund
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Skövde
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Stockholm
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Sundsvall
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Uppsala
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Västerås

Other trials in Sweden

Norway16 sites

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Arendal
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Bergen
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Bodø
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Drammen
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Flekkefjord
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Gjøvik
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Hamar
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Kongsberg
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Kristiansand
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Lillehammer
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Nordbyhagen
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Notodden
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Oslo
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Rud
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Tromsø
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Tynset

Other trials in Norway

Czechia15 sites

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Brno, CZ
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Hradec Králové
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Jihlava
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Kladno
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Liberec
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Olomouc
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Ostrava-poruba
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Pardubice
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Prague
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Slaný
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Teplice
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Ústí nad Labem
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Ústí nad Orlicí
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Zlín
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Znojmo

Other trials in Czechia

United Kingdom15 sites

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Airdrie, Lanarkshire
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Basingstoke
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Belfast, Northern Ireland
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Birmingham
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Blackpool
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Dundee
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Edinburgh
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Glasgow
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Leicester
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London
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Manchester
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Middlesbrough
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Poole
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Sheffield
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Swansea

Other trials in United Kingdom

Argentina13 sites

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Adrogué, Buenos Aires
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Buenos Aires, Buenos Aires
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Capital Federal, Buenos Aires
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Ciudad Autonoma de Bs. As., Buenos Aires
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Córdoba, Córdoba Province
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Corrientes, Corrientes Province
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Morón, Pcia. de Buenos Aires
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Quilmes, Buenos Aires
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Rosario, Santa Fe Province
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Salta, Salta Province
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San Miguel de Tucumán, Tucuman - Argentina
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San Miguel de Tucumán
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Santa Fe, Santa Fe Province

Other trials in Argentina

Belgium13 sites

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Aalst, Belgium
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Bouge, Belgium
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Brasschaat, Belgium
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Brussels (anderlecht), Belgium
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Charleroi, Belgium
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Edegem, Belgium
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Genk, Belgium
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Hasselt, Belgium
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Huy, Belgium
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Liège, Belgium
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Mechelen, Belgium
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Mol, Belgium
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Wilrijk, Belgium

Other trials in Belgium

Portugal12 sites

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Amadora
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Aveiro
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Braga
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Coimbra
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Leiria
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Lisbon
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Penafiel
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Santa Maria da Feira
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Santarém
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Setúbal
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Vila Nova de Gaia
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Vila Real

Other trials in Portugal

Bulgaria11 sites

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Burgas
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Dimitrovgrad
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Gabrovo
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Haskovo
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Kazanlak
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Pleven
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Plovdiv
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Rousse
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Smolyan
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Sofia
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Varna

Other trials in Bulgaria

Hungary11 sites

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Budapest
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Cegléd
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Debrecen
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Gyula
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Hodmez-vasarhely
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Kaposvár
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Kecskemét
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Mosonmagyaróvár
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Pécs
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Székesfehérvár
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Zalaegerszeg

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Israel11 sites

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Afula
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Ashkelon
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Beersheba
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Hadera
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Haifa
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Holon
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Jerusalem
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Poriya M.p. Lower Galilee
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Rehovot
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Tel Aviv
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Ẕerifin

Other trials in Israel

Spain11 sites

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Barcelona, Catalonia
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Cáceres, Extremadura
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Gijón, Principality of Asturias
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Lleida, Catalonia
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Madrid, Madrid
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Málaga, Andalusia
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Palma de Mallorca, Balearic Islands
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Seville, Andalusia
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Terrassa, Catalonia
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Valencia, Valencia
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Vigo(pontevedra), Galicia

Other trials in Spain

Romania10 sites

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Brăila, Brăila County
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Brasov, Brașov County
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Bucharest
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Buzău
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Cluj-Napoca, Cluj
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Craiova
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Iași, Iaşi
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Iași
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Piteşti, Argeş
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Suceava

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Slovakia10 sites

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Bratislava
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Košice
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Liptovský Mikuláš
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Martin
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Nitra
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Nové Zámky
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Piešťany
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Ružomberok
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Trnava
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Žilina

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Australia9 sites

Research Site
Bedford Park, South Australia
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Bruce, Australian Capital Territory
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Chermside, Queensland
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Dandenong, Victoria
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Geelong, Victoria
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Herston, Queensland
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Melbourne, Victoria
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Perth, Western Australia
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Woolloongabba, Queensland

Other trials in Australia

Finland9 sites

Research Site
Hus (helsinki)
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Jyväskylä
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Kokkola, Finland
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Kuopio
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Lahti
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Lappeenranta
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Pori
Research Site
Rovaniemi, Finland
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Turku, Finland

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Austria8 sites

Research Site
Feldkirch
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Freistadt
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Graz
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Innsbruck
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Linz
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Mödling
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Vienna
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Villach

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China6 sites

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Beijing, China
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Chengdu, Sichuan
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Guangzhou, Guangdong
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Hangzhou
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Shanghai, Pudong, China
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Shenyang, Liaoning

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Greece6 sites

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Athens, Greece
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Heraklion, Crete
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Larissa, Greece
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Pátrai
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Piraeus, Greece
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Thessaloniki, Greece

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Indonesia6 sites

Research Site
Bandung, West Java
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Denpasar, Bali
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Jakarta
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Makassar
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Semarang
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Surabaya, East Java

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Mexico6 sites

Research Site
Durango, Durango
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Guadalajara, Jalisco
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Mexico City, Mexico City
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Monterrey, Nuevo León
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Puebla City, Puebla
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Zapopan, Jalisco

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South Korea6 sites

Research Site
Daegu
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Gwangju
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Seongnam, Gyeonggido
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Seoul
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Suwon
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Wŏnju

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Switzerland6 sites

Research Site
Bellinzona
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Bern
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Geneva
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Kreuzlingen
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Lugano
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Mendrisio, Canton Ticino

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Philippines5 sites

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Cebu
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Davao City
Research Site
Manila
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Pasig, Philippines
Research Site
Quezon City

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Turkey (Türkiye)5 sites

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Adana
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Ankara, Sihhiye
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Antalya
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Istanbul, Kartal
Research Site
Mersin

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Ukraine5 sites

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Dnipro
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Donetsk
Research Site
Kharkiv
Research Site
Kiev
Research Site
Makiyivka

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South Africa4 sites

Research Site
Bloemfontein, Free State
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Cape Town, Cape Town
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Pretoria
Research Site
Somerset West, Cape Town

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Malaysia3 sites

Research Site
George Town
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Kuala Lumpur, Kuala Lumpur
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Kuching, Sarawak

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Taiwan3 sites

Research Site
Kweishan Shiang, Taoyuan Hsien
Research Site
Niao-song-shiang, Kaohsiung
Research Site
Taipei

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Thailand3 sites

Research Site
Bangkok, Bangkok
Research Site
Chiang Mai, Thailand
Research Site
Khon Kaen, Thailand

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Georgia1 site

Research Site
Tbilisi

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Hong Kong1 site

Research Site
Hong Kong

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Puerto Rico1 site

Research Site
San Juan

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Singapore1 site

Research Site
Singapore, Singapore

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About this study

Official title: A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]

Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.

Conditions: Acute Coronary Syndrome
Being tested: Ticagrelor, Clopidogrel
Keywords: ACS, Acute coronary syndrome, Heart attack, Unstable angina, Coronary artery disease
Medical subject headings: Acute Coronary Syndrome, Myocardial Infarction, Angina, Unstable, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TicagrelorDrug
Also called AZD6140
Ticagrelor (AZD6140) 90 mg twice daily dose (BD)
ClopidogrelDrug
Also called Plavix®
Clopidogrel 75 mg once daily dose (ODD)

Study groups in NCT00391872
Study group	Role	What they receive
Clopidogrel	Active comparator	Oral treatment Receives: Drug: Clopidogrel
Ticagrelor	Experimental	Oral treatment Receives: Drug: Ticagrelor

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.
Measured: Randomization up to 12 months
Participants With Any Major Bleeding Event
Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
Measured: First dosing up to 12 months

Secondary outcomes (14)

Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization
Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.
Measured: Randomization up to 12 months
Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke
Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee.
Measured: Randomization up to 12 months
Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.
Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated.
Measured: Randomization up to 12 months
Participants With MI Event
Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
Measured: Randomization up to 12 months
Participants With Death From Vascular Causes
Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
Measured: Randomization up to 12 months
Participants With Stroke
Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
Measured: Randomization up to 12 months
Participants With Death From Any Cause
Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
Measured: Randomization up to 12 months
Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding
Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
Measured: First dosing up to 12 months
Participants With Major or Minor Bleeding
Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
Measured: First dosing up to 12 months
Participants With Non-procedural Major Bleeding
Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
Measured: First dosing up to 12 months
Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding
Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.
Measured: First dosing up to 12 months
Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding
Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.
Measured: First dosing up to 12 months
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization
Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists.
Measured: 1-week period following randomization
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization
Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists.
Measured: 1-week period following randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Mar 2009

First posted25 Oct 2006 (estimated)
Study startOct 2006
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (62)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18,624 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00391872
Sponsor's protocol ID: D5130C05262
Other IDs: PLATO
Acronym: PLATO
Status last verified: Feb 2012
First submitted: 23 Oct 2006
Last updated: 13 Mar 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Serebruany VL, Tanguay JF, Gurvich ML, Marciniak TA, Atar D. Strokes and Transient Ischemic Attacks Occurrence During Annual Dual Antiplatelet Therapy. Am J Ther. 2023 Sep-Oct 01;30(5):e411-e415. doi: 10.1097/MJT.0000000000001622. Epub 2023 Mar 29.
PubMed 37713684
Hjort M, Eggers KM, Lakic TG, Lindback J, Budaj A, Cornel JH, Giannitsis E, Katus HA, Siegbahn A, Storey RF, Becker RC, Wallentin L, Lindahl B; PLATO trial investigators*. Biomarker Concentrations and Their Temporal Changes in Patients With Myocardial Infarction and Nonobstructive Compared With Obstructive Coronary Arteries: Results From the PLATO Trial. J Am Heart Assoc. 2023 Jan 3;12(1):e027466. doi: 10.1161/JAHA.122.027466. Epub 2022 Dec 24.
PubMed 36565198
Batra G, Lindback J, Becker RC, Harrington RA, Held C, James SK, Kempf T, Lopes RD, Mahaffey KW, Steg PG, Storey RF, Swahn E, Wollert KC, Siegbahn A, Wallentin L. Biomarker-Based Prediction of Recurrent Ischemic Events in Patients With Acute Coronary Syndromes. J Am Coll Cardiol. 2022 Nov 1;80(18):1735-1747. doi: 10.1016/j.jacc.2022.08.767.
PubMed 36302586
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
PubMed 35224730
Samman KN, Mehanna P, Takla E, Grenier JC, Chan MY, Lopes RD, Neely ML, Wang TY, Newby LK, Becker RC, Lordkipanidze M, Ruiz M, Hussin JG, Jolicoeur EM. Differential modulation of polyunsaturated fatty acids in patients with myocardial infarction treated with ticagrelor or clopidogrel. Cell Rep Med. 2021 Jun 4;2(6):100299. doi: 10.1016/j.xcrm.2021.100299. eCollection 2021 Jun 15.
PubMed 34195679
Thi Thu Nguyen T, Van Do D, Mellstrom C, Quang Nguyen T, Manh Pham H, Van Hoang S, Cong Luu T, Le Phuong T. Cost-Effectiveness of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome from Vietnamese Healthcare Payers' Perspective. Adv Ther. 2021 Jul;38(7):4026-4039. doi: 10.1007/s12325-021-01743-5. Epub 2021 Jun 11.
PubMed 34115329
Mahmoodi BK, Eriksson N, Vos GJA, Meijer K, Siegbahn A, James S, Wallentin L, Ten Berg JM. Factor V Leiden Does Not Modify the Phenotype of Acute Coronary Syndrome or the Extent of Myocardial Necrosis. J Am Heart Assoc. 2021 Jun;10(11):e020025. doi: 10.1161/JAHA.120.020025. Epub 2021 May 17.
PubMed 33998271
Gregersen I, Michelsen AE, Lunde NN, Akerblom A, Lakic TG, Skjelland M, Ryeng Skagen K, Becker RC, Lindback J, Himmelmann A, Solberg R, Johansen HT, James SK, Siegbahn A, Storey RF, Kontny F, Aukrust P, Ueland T, Wallentin L, Halvorsen B. Legumain in Acute Coronary Syndromes: A Substudy of the PLATO (Platelet Inhibition and Patient Outcomes) Trial. J Am Heart Assoc. 2020 Sep;9(17):e016360. doi: 10.1161/JAHA.120.016360. Epub 2020 Aug 15.
PubMed 32809893
Sumaya W, Wallentin L, James SK, Siegbahn A, Gabrysch K, Himmelmann A, Ajjan RA, Storey RF. Impaired Fibrinolysis Predicts Adverse Outcome in Acute Coronary Syndrome Patients with Diabetes: A PLATO Sub-Study. Thromb Haemost. 2020 Mar;120(3):412-422. doi: 10.1055/s-0039-1701011. Epub 2020 Jan 23.
PubMed 31975352
Ueland T, Akerblom A, Ghukasyan T, Michelsen AE, Becker RC, Bertilsson M, Budaj A, Cornel JH, Himmelmann A, James SK, Siegbahn A, Storey RF, Kontny F, Aukrust P, Wallentin L; PLATO Investigators. ALCAM predicts future cardiovascular death in acute coronary syndromes: Insights from the PLATO trial. Atherosclerosis. 2020 Jan;293:35-41. doi: 10.1016/j.atherosclerosis.2019.11.031. Epub 2019 Nov 29.
PubMed 31835039
Andersen T, Ueland T, Ghukasyan Lakic T, Akerblom A, Bertilsson M, Aukrust P, Michelsen AE, James SK, Becker RC, Storey RF, Wallentin L, Siegbahn A, Kontny F. C-X-C Ligand 16 Is an Independent Predictor of Cardiovascular Death and Morbidity in Acute Coronary Syndromes. Arterioscler Thromb Vasc Biol. 2019 Nov;39(11):2402-2410. doi: 10.1161/ATVBAHA.119.312633. Epub 2019 Sep 26.
PubMed 31554419
Akerblom A, Wojdyla DM, Wallentin L, James SK, de Souza Brito F, Steg PG, Cannon CP, Katus HA, Himmelmann A, Storey RF, Becker RC, Lopes RD; PLATO Investigators. Ticagrelor in patients with heart failure after acute coronary syndromes-Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2019 Jul;213:57-65. doi: 10.1016/j.ahj.2019.04.006. Epub 2019 Apr 18.
PubMed 31108273
Franchi F, James SK, Ghukasyan Lakic T, Budaj AJ, Cornel JH, Katus HA, Keltai M, Kontny F, Lewis BS, Storey RF, Himmelmann A, Wallentin L, Angiolillo DJ; PLATO Investigators. Impact of Diabetes Mellitus and Chronic Kidney Disease on Cardiovascular Outcomes and Platelet P2Y12 Receptor Antagonist Effects in Patients With Acute Coronary Syndromes: Insights From the PLATO Trial. J Am Heart Assoc. 2019 Mar 19;8(6):e011139. doi: 10.1161/JAHA.118.011139.
PubMed 30857464
Lindholm D, James SK, Gabrysch K, Storey RF, Himmelmann A, Cannon CP, Mahaffey KW, Steg PG, Held C, Siegbahn A, Wallentin L. Association of Multiple Biomarkers With Risk of All-Cause and Cause-Specific Mortality After Acute Coronary Syndromes: A Secondary Analysis of the PLATO Biomarker Study. JAMA Cardiol. 2018 Dec 1;3(12):1160-1166. doi: 10.1001/jamacardio.2018.3811.
PubMed 30427997
Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.
PubMed 29910052

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]
ClinicalTrials.gov ID: NCT00391872
Acronym / sponsor ID: PLATO / D5130C05262
Conditions: Acute Coronary Syndrome
Keywords: ACS, Acute coronary syndrome, Heart attack, Unstable angina, Coronary artery disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 18,624 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 25 Oct 2006 (estimated)
Results: Posted 13 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Clopidogrel	Active comparator	Drug: ClopidogrelOral treatment
Ticagrelor	Experimental	Drug: TicagrelorOral treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception

Key exclusion criteria (3 listed)

Persons with moderate or severe liver disease
Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
Persons who are being treated with blood clotting agents that cannot be stopped

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TicagrelorAlso: AZD6140Ticagrelor (AZD6140) 90 mg twice daily dose (BD)	Drug	Ticagrelor
ClopidogrelAlso: Plavix®Clopidogrel 75 mg once daily dose (ODD)	Drug	Clopidogrel

Primary outcome

Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
Time frame: Randomization up to 12 months
Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.
Participants With Any Major Bleeding Event
Time frame: First dosing up to 12 months
Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.

14 secondary outcomes

Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization
Time frame: Randomization up to 12 months
Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke
Time frame: Randomization up to 12 months
Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.
Time frame: Randomization up to 12 months
Participants With MI Event
Time frame: Randomization up to 12 months
Participants With Death From Vascular Causes
Time frame: Randomization up to 12 months
Participants With Stroke
Time frame: Randomization up to 12 months
Participants With Death From Any Cause
Time frame: Randomization up to 12 months
Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding
Time frame: First dosing up to 12 months
Participants With Major or Minor Bleeding
Time frame: First dosing up to 12 months
Participants With Non-procedural Major Bleeding
Time frame: First dosing up to 12 months
Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding
Time frame: First dosing up to 12 months
Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding
Time frame: First dosing up to 12 months
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization
Time frame: 1-week period following randomization
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization
Time frame: 1-week period following randomization

Results and safety

Results posted to the registry on 13 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TICAGRELOR	9,333	9,026
CLOPIDOGREL	9,291	9,036

Primary outcome: Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke

Time frame: Randomization up to 12 months. Number. Unit: Participants

Measure	TICAGRELOR n = 9333	CLOPIDOGREL n = 9291
Value	864	1014

Population analysed: The population was the full analysis set, which included all randomized patients

Primary outcome: Participants With Any Major Bleeding Event

Time frame: First dosing up to 12 months. Number. Unit: Participants

Measure	TICAGRELOR n = 9235	CLOPIDOGREL n = 9186
Value	961	929

Population analysed: The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TICAGRELOR	2,108 of ?	2,278 of ?	Not reported
CLOPIDOGREL	2,117 of ?	1,665 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37713684Serebruany VL, Tanguay JF, Gurvich ML, Marciniak TA, Atar D. Strokes and Transient Ischemic Attacks Occurrence During Annual Dual Antiplatelet Therapy. Am J Ther. 2023 Sep-Oct 01;30(5):e411-e415. doi: 10.1097/MJT.0000000000001622. Epub 2023 Mar 29.
Derived from this study: PubMed 36565198Hjort M, Eggers KM, Lakic TG, Lindback J, Budaj A, Cornel JH, Giannitsis E, Katus HA, Siegbahn A, Storey RF, Becker RC, Wallentin L, Lindahl B; PLATO trial investigators*. Biomarker Concentrations and Their Temporal Changes in Patients With Myocardial Infarction and Nonobstructive Compared With Obstructive Coronary Arteries: Results From the PLATO Trial. J Am Heart Assoc. 2023 Jan 3;12(1):e027466. doi: 10.1161/JAHA.122.027466. Epub 2022 Dec 24.
Derived from this study: PubMed 36302586Batra G, Lindback J, Becker RC, Harrington RA, Held C, James SK, Kempf T, Lopes RD, Mahaffey KW, Steg PG, Storey RF, Swahn E, Wollert KC, Siegbahn A, Wallentin L. Biomarker-Based Prediction of Recurrent Ischemic Events in Patients With Acute Coronary Syndromes. J Am Coll Cardiol. 2022 Nov 1;80(18):1735-1747. doi: 10.1016/j.jacc.2022.08.767.
Derived from this study: PubMed 35224730Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Derived from this study: PubMed 34195679Samman KN, Mehanna P, Takla E, Grenier JC, Chan MY, Lopes RD, Neely ML, Wang TY, Newby LK, Becker RC, Lordkipanidze M, Ruiz M, Hussin JG, Jolicoeur EM. Differential modulation of polyunsaturated fatty acids in patients with myocardial infarction treated with ticagrelor or clopidogrel. Cell Rep Med. 2021 Jun 4;2(6):100299. doi: 10.1016/j.xcrm.2021.100299. eCollection 2021 Jun 15.
Derived from this study: PubMed 34115329Thi Thu Nguyen T, Van Do D, Mellstrom C, Quang Nguyen T, Manh Pham H, Van Hoang S, Cong Luu T, Le Phuong T. Cost-Effectiveness of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome from Vietnamese Healthcare Payers' Perspective. Adv Ther. 2021 Jul;38(7):4026-4039. doi: 10.1007/s12325-021-01743-5. Epub 2021 Jun 11.
Derived from this study: PubMed 33998271Mahmoodi BK, Eriksson N, Vos GJA, Meijer K, Siegbahn A, James S, Wallentin L, Ten Berg JM. Factor V Leiden Does Not Modify the Phenotype of Acute Coronary Syndrome or the Extent of Myocardial Necrosis. J Am Heart Assoc. 2021 Jun;10(11):e020025. doi: 10.1161/JAHA.120.020025. Epub 2021 May 17.
Derived from this study: PubMed 32809893Gregersen I, Michelsen AE, Lunde NN, Akerblom A, Lakic TG, Skjelland M, Ryeng Skagen K, Becker RC, Lindback J, Himmelmann A, Solberg R, Johansen HT, James SK, Siegbahn A, Storey RF, Kontny F, Aukrust P, Ueland T, Wallentin L, Halvorsen B. Legumain in Acute Coronary Syndromes: A Substudy of the PLATO (Platelet Inhibition and Patient Outcomes) Trial. J Am Heart Assoc. 2020 Sep;9(17):e016360. doi: 10.1161/JAHA.120.016360. Epub 2020 Aug 15.
Derived from this study: PubMed 31975352Sumaya W, Wallentin L, James SK, Siegbahn A, Gabrysch K, Himmelmann A, Ajjan RA, Storey RF. Impaired Fibrinolysis Predicts Adverse Outcome in Acute Coronary Syndrome Patients with Diabetes: A PLATO Sub-Study. Thromb Haemost. 2020 Mar;120(3):412-422. doi: 10.1055/s-0039-1701011. Epub 2020 Jan 23.
Derived from this study: PubMed 31835039Ueland T, Akerblom A, Ghukasyan T, Michelsen AE, Becker RC, Bertilsson M, Budaj A, Cornel JH, Himmelmann A, James SK, Siegbahn A, Storey RF, Kontny F, Aukrust P, Wallentin L; PLATO Investigators. ALCAM predicts future cardiovascular death in acute coronary syndromes: Insights from the PLATO trial. Atherosclerosis. 2020 Jan;293:35-41. doi: 10.1016/j.atherosclerosis.2019.11.031. Epub 2019 Nov 29.
Derived from this study: PubMed 31554419Andersen T, Ueland T, Ghukasyan Lakic T, Akerblom A, Bertilsson M, Aukrust P, Michelsen AE, James SK, Becker RC, Storey RF, Wallentin L, Siegbahn A, Kontny F. C-X-C Ligand 16 Is an Independent Predictor of Cardiovascular Death and Morbidity in Acute Coronary Syndromes. Arterioscler Thromb Vasc Biol. 2019 Nov;39(11):2402-2410. doi: 10.1161/ATVBAHA.119.312633. Epub 2019 Sep 26.
Derived from this study: PubMed 31108273Akerblom A, Wojdyla DM, Wallentin L, James SK, de Souza Brito F, Steg PG, Cannon CP, Katus HA, Himmelmann A, Storey RF, Becker RC, Lopes RD; PLATO Investigators. Ticagrelor in patients with heart failure after acute coronary syndromes-Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2019 Jul;213:57-65. doi: 10.1016/j.ahj.2019.04.006. Epub 2019 Apr 18.

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Acute Coronary Syndromes, Chest Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Harrington, MD principal investigator

Duke Clinical Research Institute

Lars Wallentin, MD principal investigator

Uppsala Clinical Research Centre

Jonathan C. Fox, MD study director

AstraZeneca

672 sites in 44 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor and Clopidogrel in people with Acute Coronary Syndrome, run by AstraZeneca at 672 sites in 44 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 672 sites in United States, Germany, Netherlands, France, Poland and 39 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke (time frame: Randomization up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00391872, which also lists 62 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2012; AzTrials last refreshed its copy on 26 Oct 2026.