AzTrials
AzTrials

Acute Coronary SyndromePhase 3COGENT-1NCT00557921

Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)

A Phase 3 study testing CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin and Plavix (clopidogrel 75 mg) and aspirin in people with Acute Coronary Syndrome and Myocardial Infarction, run by Cogentus Pharmaceuticals at 491 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin and Plavix (clopidogrel 75 mg) and aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,000 participants
Where
491 sitesin 16 countries
Study dates
Dec 2007to Nov 2009
Phase
Phase 3
Are there results?
None posted in the registry

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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients in whom a requirement for clopidogrel therapy with concomitant aspirin is anticipated for at least the next 12 months. Specific conditions that may confer a need for long-term clopidogrel + aspirin therapy may include non-ST segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI), ST segment elevation acute MI), or new placement of a coronary artery stent.
  • For women of childbearing potential, negative pregnancy test prior to randomization and agreement to use effective method of birth control during the study.
  • Able to provide written informed consent based on competent mental status.

Who cannot join

  • Patients currently hospitalized for whom discharge is not anticipated within 48 hours of randomization.
  • Requirement for current or chronic use of a proton pump inhibitor, H2 receptor blocker, sucralfate or misoprostol.
  • Erosive esophagitis, esophageal or gastric variceal disease, or non-endoscopic gastric surgery. Patients with a history of GERD/erosive esophagitis or dyspepsia who do not currently require proton pump blockers will be eligible.
  • Receipt of > 21 days of clopidogrel or another thienopyridine prior to randomization.
  • Oral anticoagulation that cannot be safely discontinued for duration of study.
  • Recent fibrinolytic therapy.
Show all 17Show fewer
  • Scheduled percutaneous coronary intervention (PCI). Patients may be enrolled upon completion of PCI.
  • Recent (< 30 days prior to randomization) or scheduled coronary artery bypass graft (CABG) surgery.
  • Cardiogenic shock at time of randomization, refractory ventricular arrhythmias, or congestive heart failure (NY Heart Association class IV).
  • Active pathological bleeding or a history of hereditary or acquired hemostatic disorder.
  • History of hemorrhagic stroke, intracranial neoplasm, arteriovenous malformation or aneurysm.
  • Systemic corticosteroids except low-dose oral corticosteroids equivalent to prednisone < or equal to 5 mg/day.
  • Allergy or contraindication to clopidogrel or other thienopyridine drugs, omeprazole or other proton pump inhibitor drugs, aspirin or salicylate derivatives, or other study drug ingredients.
  • Treatment within 30 days prior to randomization with any investigational drug or device including investigational coronary artery stents or currently enrolled in another interventional drug or device study.
  • Women who are pregnant or breastfeeding.
  • Life expectancy less than 12 months.
  • Laboratory abnormality at screening that is clinically significant or outside protocol-allowed limits, or any other condition that precludes participation in the study in the opinion of the Investigator.

Trial locations and contacts

491 sites in 16 countries.

491 sites in 16 countries

United States247 sites

  • Abington Medical Specialists

    Abington, Pennsylvania, 19001

  • Capital Cardiology Associates

    Albany, New York, 12211

  • Alabama Clinical Research Institute, Inc. (ACRI)

    Alexander City, Alabama, 35010

  • Cardiology Consultants of Orange County

    Anaheim, California, 92801

  • Chest and Critical Care Consultants, A Medical Group

    Anaheim, California, 92801

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Family Health Care Assoc.

    Arlington, Texas, 76013

  • Clinical Study Center of Asheville, LLC

    Asheville, North Carolina, 28803

  • Cumberland Cardiology

    Ashland, Kentucky, 41101

  • McMinn Medical Group (DBA: Athens Medical Group)

    Athens, Tennessee, 37303

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Primary Care Specialists, LLC/ ECAST CT

    Atlanta, Georgia, 30312

  • Executive Health and Research Associates, Inc.

    Atlanta, Georgia, 30342

  • Maine Research Associates

    Auburn, Maine, 04210

  • American Health Network

    Avon, Indiana, 46123

  • Good Samaritan Hospital (Medstar Health)

    Baltimore, Maryland, 21239

  • Bluestem Cardiology Research Dept.

    Bartlesville, Oklahoma, 74006

  • Verzosa & Ungab Internal Medicine Associates

    Bartlett, Tennessee, 38134

  • Dolby Research, LLC

    Baton Rouge, Louisiana, 33437

  • Michigan Cardiovascular Institute

    Bay City, Michigan, 48708

  • Southeast Texas Clinical Research Center

    Beaumont, Texas, 77702

  • Tri-State Medical Group

    Beaver, Pennsylvania, 15009

  • Bend Memorial Clinic

    Bend, Oregon, 97701

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35126

  • Cardio-Thoracic Surgeons P.C.

    Birmingham, Alabama, 35213

  • Birmingham Heart Clinic, PC

    Birmingham, Alabama, 35235

  • St. Alexius Medical Center

    Bismarck, North Dakota, 58501

  • George G. Ellis, Jr. M.D., Inc.

    Boardman, Ohio, 44512

  • Connecticut Clinical Research

    Bridgeport, Connecticut, 06606

  • Clinical Solutions Advantage

    Buena Park, California, 90620

  • Daniel W. Gottlieb, MD, PS

    Burien, Washington, 98166

  • Kernodle Clinic, Inc.

    Burlington, North Carolina, 27215

  • Heritage Cardiology Association

    Camp Hill, Pennsylvania, 17011

  • Cardiovascular Research Institute, LLC

    Canton, Ohio, 44710

  • Trinity Hypertension and Diagnostic Res.

    Carrollton, Texas, 75006

  • Turns Institute for Clinical Research

    Castro Valley, California, 94546

  • Metrolina Medical Research

    Charlotte, North Carolina, 28209

  • Associated Cardiovascular Consultants

    Cherry Hill, New Jersey, 08034

  • PPS Clinical Research, STL, LLC

    Chesterfield, Missouri, 63017

  • Comprehensive Cardiology Consultants, Inc.

    Cincinnati, Ohio, 45236

  • Colorado Springs Health Partners

    Colorado Springs, Colorado, 80907

  • Southeast Regional Research Group

    Columbus, Georgia, 31904

  • Midwest Cardiology Research Foundation

    Columbus, Ohio, 43214

  • Oscar R. Guerra, MD PA

    Coral Gables, Florida, 33134

  • Hudson Valley Cardiology Group, P.C.

    Cortlandt Manor, New York, 10567

  • Georgia Heart Specialists, LLC

    Covington, Georgia, 30014

  • New England Center for Clinical Research&comma; Inc

    Cranston, Rhode Island, 02920

  • VA Medical Center

    Dallas, Texas, 75216

  • U.T. Southwestern

    Dallas, Texas, 75390

  • Cardiology Consultants of Danville

    Danville, Virginia, 24541

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52803

  • Ialum Clinical Research Center, LLC

    Decatur, Georgia, 30032

  • Ialum Clinical Research Center

    Decatur, Georgia, 30032

  • Ialum Clinical Research Center

    Decatur, Georgia, 30035

  • Deerfield Beach Cardiology Associates

    Deerfield Beach, Florida, 33442

  • Duluth Clinic / Saint Marys Medical Center

    Duluth, Minnesota, 55805

  • Diversified Research

    Durham, North Carolina, 27704

  • Premier Heart Specialists

    Easton, Pennsylvania, 18042

  • Indiana Medical Research

    Elkhart, Indiana, 46514

  • Cardiovascular Associates of the Delaware Valley, P.A.

    Elmer, New Jersey, 08318

  • Heart Specialists of Lancaster

    Ephrata, Pennsylvania, 17522

  • Escondido Cardiology Associates

    Escondido, California, 92025

  • Welborn Clinic

    Evansville, Indiana, 47713

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • Middle Tennessee Clinical Research

    Fayetteville, Tennessee, 37334

  • Apex Medical Research, AMR, Inc.

    Flint, Michigan, 48504

  • South Suburban Health Professional Group, PC

    Flossmoor, Illinois, 60422

  • Amir Malik Research

    Fort Worth, Texas, 76104

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Triad Research Institute

    Galax, Virginia, 24333

  • The University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555-0553

  • John F Simmons , MD PC

    Geneva, Alabama, 36340

  • Altru Health Systems

    Grand Forks, North Dakota, 58201

  • eCast Corporation

    Greenbelt, Maryland, 20770

  • New Coast Cardiology Center, PLLC

    Gulfport, Mississippi, 39503

  • Cardiovascular Associates of the Delaware Valley, P.A.

    Haddon Heights, New Jersey, 08035

  • Dr Jules Cohen

    Hallandale, Florida, 33009

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Pentucket Medical Associates

    Haverhill, Massachusetts, 01830

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Empire International Research

    Hialeah, Florida, 33012

  • Hillsboro Cardiology, PC

    Hillsboro, Oregon, 97123

  • Cardiovascular Consultants of South Florida

    Hollywood, Florida, 33021

  • Clinical Research Consultants, Inc.

    Hoover, Alabama, 35216

  • Tri-Lakes Research

    Hot Springs, Arkansas, 71901

  • Michael A. Frais, Cardiologist, P.A.

    Hot Springs, Arkansas, 71913

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70301

  • East Texas Cardiology PA

    Houston, Texas, 77002

  • Office of Amer Zaheer, MD

    Houston, Texas, 77004

  • Office of Salim Gopalani, MD

    Houston, Texas, 77008

  • Comprehensive Heart Care, PA

    Houston, Texas, 77024

  • Century Clinical Research

    Houston, Texas, 77036

  • Office of Mizra Basith Baig, MD

    Houston, Texas, 77055

  • The Heart Center, PC

    Huntsville, Alabama, 35801

  • Hutchinson Clinic, P.A.

    Hutchinson, Kansas, 67502

  • Indiana Heart Physicians

    Indianapolis, Indiana, 46237

  • Research Associates of Jackson and Apex Cardiology

    Jackson, Tennessee, 38301

  • Jacksonville Heart Center

    Jacksonville, Florida, 32207

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Jacksonville Heart Center

    Jacksonville, Florida, 32250

  • Pennsylvania Heart and Vascular Group, P.C.

    Jenkintown, Pennsylvania, 19046

  • Cardiology Associates, P.C.

    Johnson City, New York, 13790

  • Tri-State Cardiology

    Johnson City, Tennessee, 37601

  • NEA-Clinic Cardiology

    Jonesboro, Arkansas, 72401

  • CVMS Resesarch Institute, LLC

    Jupiter, Florida, 33458

  • Borgess Research Institute

    Kalamazoo, Michigan, 49048

  • Glacier View Cardiology

    Kalispell, Montana, 59901

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

  • Accurate Clinical Trials, Inc.

    Laguna Hills, California, 92653

  • Therapeutic Research Institute of Orange County

    Laguna Hills, California, 92653

  • Watson Clinic Center for Research

    Lakeland, Florida, 33805

  • Kirtik Thaker MD

    Lakewood, California, 90712

  • Comprehensive Cardiology Consultants

    Langhorne, Pennsylvania, 19047

  • Nevada Cardiology Associates

    Las Vegas, Nevada, 89128

  • Sewickley Valley Medical Group Cardiology

    Leetsdale, Pennsylvania, 15056

  • Los Angeles Cardiology Associates

    Los Angeles, California, 90017

  • Covenant Cardiology Associates

    Lubbock, Texas, 79410

  • Wisconsin Heart, S.C.

    Madison, Wisconsin, 53715

  • Trover Health System

    Madisonville, Kentucky, 42431

  • Heart Clinic of Louisiana Clinical Research, LLC.

    Marrero, Louisiana, 70072

  • South Texas Institutes of Health

    McAllen, Texas, 78572

  • Alpha Medical Research, LLC

    Melbourne, Florida, 32901

  • Consultants in Cardiovascular Medicine

    Melrose Park, Illinois, 60160

  • Memphis Internal Medicine

    Memphis, Tennessee, 38119

  • Goodlife Medical Center

    Memphis, Tennessee, 38120

  • Merced Heart Associates

    Merced, California, 95348

  • Advanced Cardiac Specialists

    Mesa, Arizona, 85206

  • Empire International Research

    Miami, Florida, 33125

  • Suncoast Research Group, LLC

    Miami, Florida, 33144

  • Cardiovascular Research Center of South Florida

    Miami, Florida, 33173

  • Research Center Phase I-IV of Florida Corp.

    Miami, Florida, 33175

  • Empire International Research

    Miami, Florida, 33186

  • Michigan Cardiovascular Institute

    Midland, Michigan, 48670

  • Heart Care Associates, LLC

    Milwaukee, Wisconsin, 53215

  • Long Island Heart Associates

    Mineola, New York, 11501

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Trinity Health

    Minot, North Dakota, 58701

  • Venture Resource Group, Inc.

    Mission, Kansas, 66202

  • Mission Internal Medical Group

    Mission Viejo, California, 92691

  • Saint Patrick Hospital- International Heart Institute of Montana

    Missoula, Montana, 59802

  • Mobile Heart Specialists, PC

    Mobile, Alabama, 36608

  • Altos Cardiovascular Associates

    Mountain View, California, 94040

  • Lahey Cardiology @ the Medical Center

    Nashua, New Hampshire, 03060

  • Heart and Vascular Clinic

    Nashville, Tennessee, 37203

  • Charles River Medical Associates

    Natick, Massachusetts, 01760

  • Slocum-Dickson Medical Group, PLLC

    New Hartford, New York, 13413

  • Sound Shore Cardiology, P.C.

    New Rochelle, New York, 10801

  • Bert Fish Medical Center

    New Smyrna Beach, Florida, 32168

  • New York Cardiovascular Associate

    New York, New York, 10001

  • St. Luke's- Roosevelt Hospital

    New York, New York, 10025

  • Alfieri Cardiology, PA

    Newark, Delaware, 19713

  • Cardiology Consultants of Philadelphia

    Norristown, Pennsylvania, 19401

  • Kenneth W. Carr, MD, Cardiology

    Oceanside, California, 92056

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73109

  • The Creighton Cardiac Center

    Omaha, Nebraska, 68131

  • Central Florida Cardiology Group

    Orlando, Florida, 32803

  • Cardiology Assocaites of Orlando d/b/a Orlando Heart Center

    Orlando, Florida, 32806

  • Midwest Cardiology Assocaites

    Overland Park, Kansas, 66209

  • Owensboro Heart and Vascular

    Owensboro, Kentucky, 42303

  • Cardiovascular Care of Northern Carolina

    Oxford, North Carolina, 27565

  • Sunset Point Medical Associates

    Palm Harbor, Florida, 34684

  • Alegent Health Clinic Heart and Vascular Specialist

    Papillion, Nebraska, 68046

  • Parkersburg Cardiology Associates

    Parkersburg, West Virginia, 26101

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61606

  • Hospital of the University of Pennsylvania Cardiology Department

    Philadelphia, Pennsylvania, 19104

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania, 19111

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania, 19148

  • Redpoint Research

    Phoenix, Arizona, 85029

  • Cardiovascular Consultants, Ltd.

    Phoenix, Arizona, 85032

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • Texas Regional Heart Center d/b/a Legacy Heart Center

    Plano, Texas, 75024

  • Berma Research Group

    Plantation, Florida, 33317

  • Charlotte Heart Group Research Center

    Port Charlotte, Florida, 33952

  • Legacy Clinical Research

    Portland, Oregon, 97210

  • Rhode Island Hospital Cardiology

    Providence, Rhode Island, 02903

  • Rancho CucamongaClinical Trials

    Rancho Cucamonga, California, 91703

  • Virginia Cardiovascular Specialists

    Richmond, Virginia, 23226

  • Rochester General Hospital

    Rochester, New York, 14621

  • Michigan Cardiovascular Institute

    Saginaw, Michigan, 48601

  • Covenant Medical Center, Inc.

    Saginaw, Michigan, 48602

  • Academic Heart and Vascular PLLC

    Saint Clair Shores, Michigan, 48081

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Atlantic Cardiology Associates, P.A

    Salisbury, Maryland, 21801

  • Peninsula Cardiology Associates

    Salisbury, Maryland, 21804

  • Heart & Vascular Institute of Texas

    San Antonio, Texas, 78217

  • Cardiology Clinic of San Antonio

    San Antonio, Texas, 78229

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78229

  • IMED Research, PA

    San Antonio, Texas, 78258

  • Inland Heart and Vascular Medical Associates

    San Bernardino, California, 92404

  • Ritchken and First

    San Diego, California, 92117

  • Rider Research Group

    San Francisco, California, 94117

  • Richard Levy, MD.

    San Francisco, California, 94118

  • Kaiser Permanente

    San Jose, California, 95119

  • Medical Helping Hands Research

    Santa Ana, California, 92704

  • Pacific Heart Institute

    Santa Monica, California, 90404

  • Radiant Research

    Santa Rosa, California, 95405

  • Saratoga Cardiology Assoc, PC

    Saratoga Springs, New York, 12866

  • Southeast Regional Research Group

    Savannah, Georgia, 31406

  • Cardiovascular Consultants of Maine, PA

    Scarborough, Maine, 04074

  • Westchester Cardiology Associates

    Scarsdale, New York, 10583

  • Advanced Cardiology Specialists

    Scranton, Pennsylvania, 18501

  • Searcy Medical Center

    Searcy, Arkansas, 72143

  • Elite Medical Research, Inc.

    Sellersville, Pennsylvania, 18960

  • Cardiovascular Associates of the Delaware Valley, P.A.

    Sewell, New Jersey, 08080

  • Cochise Clinical Research

    Sierra Vista, Arizona, 85635

  • Maine Cardiology Associates

    South Portland, Maine, 04106

  • Heart Clinic Northwest

    Spokane, Washington, 99204

  • Inland Cardiology Assocaites

    Spokane, Washington, 99204

  • Cardiology Diagnostics, Ltd.

    St Louis, Missouri, 63122

  • Suncoast Cardiovascular Research

    St. Petersburg, Florida, 33701

  • The Heart and Vascular Institute of Florida

    St. Petersburg, Florida, 33709

  • Medsouth Primary CareStockbridge

    Stockbridge, Georgia, 30281

  • Good Samaritan Hospital

    Suffern, New York, 10901

  • Southwest Health Associate, PA

    Sugar Land, Texas, 77478

  • Office of Dwayne O. Williams, MD

    Sugarland, Texas, 77479

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Cardiology, PC

    Syracuse, New York, 13210

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Franciscan Health System dba FHS Research Center

    Tacoma, Washington, 98405

  • Kings Daughters Clinic

    Temple, Texas, 76502

  • Cardiac Care and Vascular Medicine, Albert Einstein College of Medicine

    The Bronx, New York, 10469

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Physicans Research Center, LLC

    Toms River, New Jersey, 08755

  • Harbor- UCLA Medical Center

    Torrance, California, 90509

  • Oakland Medical Center

    Troy, Michigan, 48085

  • Capital Cardiology Associates

    Troy, New York, 12180

  • Paradigm Clinical Research, Inc.

    Tucson, Arizona, 85705

  • Cardiology Consultants of Philadelphia

    Upland, Pennsylvania, 19013

  • Ventura Cardiology Consultants Medical Group, Inc.

    Ventura, California, 93003

  • G&G Research Baker-Tombul Cardiology

    Vero Beach, Florida, 32960

  • Victoria Heart and Vascular Center

    Victoria, Texas, 77901

  • Washington V.A. Medical Center

    Washington D.C., District of Columbia, 20422

  • Waterford Medical Assoc. P.C.

    Waterford, Michigan, 48328

  • Northeast Iowa Medical Education Foundation

    Waterloo, Iowa, 50702

  • West Chester Cardiology, PC

    West Chester, Pennsylvania, 19380

  • Cardiology Specialists

    Westerly, Rhode Island, 02891

  • Carlos Levy, D.O.

    Weston, Florida, 33326

  • Buffalo Cardiology and Pulmonary Associates

    Williamsville, New York, 14221

  • Mark J. Kozinn, MD

    Williamsville, New York, 14221

  • Winchester Medical Center/ Clinical Research Department

    Winchester, Virginia, 22601

  • Berks Cardiology, Ltd.

    Wyomissing, Pennsylvania, 19610

  • Cardiology Consultants of Philadelphia

    Yardley, Pennsylvania, 19067

  • Michigan Heart, PC

    Ypsilanti, Michigan, 48106

  • Aquilo Research

    Yukon, Oklahoma, 73099

  • Cardiology Associates of SE Ohio, Inc

    Zanesville, Ohio, 43701

  • Physicans Research, Inc.

    Zanesville, Ohio, 43701

Other trials in United States

Poland62 sites

  • Oddział Kardiologii z Zakładem Diagnostyki Kardiologicznej, Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital im. dr J. Biziela,

    Bydgoszcz, 85-168

  • NZOZ "Medicus" Jacek Kubica

    Bydgoszcz, 85-435

  • Wojewódzki Szpital Meijski im. Biziela, Oddział Kardiologii - SPZOZ

    Bydgoszcz, 85-826

  • Oddział Chorób Wewnętrzych i Kardiologii , ZOZ w Debicy

    Dębica, 39-200

  • Zakład Opieki Zdrowotnej Trójmiejskie Centrum Medyczne Sp. z o.o

    Gdansk, 80-437

  • Gabinet Kardiologiczny Medipuls

    Gdynia, 81-423

  • Gabinet Kardiologiczno-Internistyczny

    Gdynia, 81-472

  • Centrum Leczenia Chorób Cywilizacyjnych Oddz. Gdynia filla Fikakowo

    Gdynia, 81-572

  • NZOZ Medicus, Poradnia Kardiologiczna

    Gliwice, 44-100

  • Oddział Kardiologii i INK, SPZOZ nr 1

    Gliwice, 44-100

  • Mazowieckie Centrum Badań Klinicznych Iwona Czajkowska, Monika Śmietańska s.c.

    Grodzisk Mazowiecki, 05-825

  • Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej Oddzial Kardiologiczny

    Inowrocław, 88-100

  • Oddział Chorób Wewnętrznych i Farmakologii Klinicznej Samodzielny Publiczny Centralny Szpital Kliniczny im. Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach

    Katowice, 40-752

  • Szpital Specjalistyczny w Kościerzynie, Oddział Kardiologii

    Kościerzyna, 83-400

  • Oddział Kardiologii, Szpital Specjalistyczny im. J. Dietla

    Krakow, 31-121

  • "Klinika Choroby Wieńcowej Instytut Kardiologii, Collegium Medicum Uniwerytet Jagielloński

    Krakow, 31-202

  • Oddzial Chorób Wewnętrznych III Szpital Specjalistyczny im.Stefana Zeromskiego, SPZOZ w Krakowie

    Krakow, 31-913

  • Niepubliczny Zakład Opieki Zdrowotnej Specjalista Sp. z o.o.

    Kutno, 99-300

  • Poradnia Kardiologiczna, Oddział Chorob Wewnetrznych Szpital Powiatowy w Limanowej

    Limanowa, 34-600

  • Niepubliczny Zakład Opieki Zdrowotnej POLIMEDICA

    Lodz, 90-302

  • All-Med Centrum Medyczne

    Lodz, 94-050

  • Oddział Kardiologiczny Szpital Wojewódzki im. Kardynała Stefana Wyszyńskiego

    Łomża, 18-404

  • Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Zakład Opieki Zdrowotnej

    Lubartów, 21-100

  • "Oddzial Chorob Wewnetrznych i Kardiologii, Szpital Powiatowy im.Edmunda Biernackiego

    Mielec, 39-300

  • Oddział Kardiologii, Nowa Sól

    Nowa Sól, 67-100

  • ZOZ w Oławie, Oddział Chorób Wewnętrznych

    Oława, 55-200

  • "Oddział Kardiologiczno-Internistyczny

    Olsztyn, 10-045

  • "Oddział Kardiologiczny Publiczny Samodzielny ZOZ Wojewódzkie Centrum Medyczne

    Opole, 45-418

  • Specjalistyczny Zakład Opieki Zdrowotnej Poradnia lekarzy specjalistów "Jantar"

    Ostrów Wielkopolski, 63-400

  • II Oddział Wewnętrzny Samodzielny Publiczny Zakład Opieki Zdrowotnej

    Pabianice, 95-200

  • "Samodzielny Szpital Wojewódzki im. Mikołaja Kopernika, Oddział Kardiologiczny

    Piotrkow Trybunalski, 97-300

  • Wojewódzki Szpital Zespolony, Oddział Kardiologiczny

    Płock, 09-400

  • Specjalistyczna Przychodnia Lekarska "Medikard"

    Płock, 09-402

  • Medyczne Centrum Hetmańska, Indywiualna Specjalistyczna Praktyka Lekarska, Dr n. med. Piotr Leszczyński

    Poznan, 60-218

  • Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwór

    Poznan, 60-539

  • Oddział Wewnetrzny I, Szpital Kolejowy im. dr med. Włodzimierza Roeslera

    Pruszków, 05-800

  • Samodzileny Publiczny Zakład Opieki Zdrowotnej w Puławach, Szpital Specjalistyczny

    Puławy, 24-100

  • Zakład Hemodynamiki, Wojewódzki Szpital Specjalistyczny

    Radom, 26-617

  • "Oddział Kardiologii z Pododdziałem Ostrych Zespołów Wieńcowych i z Ośrodkiem Implantacji Rozruszników Serca,

    Rzeszów, 35-301

  • Oddział Kardiologii, SP ZZOZ Sandomierz

    Sandomierz, 27-600

  • Oddział Kardiologiczny Wojewódzki Szpital Specjalistyczy w Siedlcach

    Siedlce, 08-110

  • Oddział Kardiologii Samodzielny Publiczny Zakład Opieki Zdrowotnej w Sieradzu im. Kardynała Stefana Wyszyńskiego

    Sieradz, 98-200

  • "Oddział Kardiologii, Wojewódzki Szpital Zespolony w Skierniewicach, "

    Skierniewice, 96-100

  • NZOZ Przychodnia Zadebie, Przychodnia Kardiologiczna

    Skierniewice, 96-100

  • "Oddział Kardiologii Inwazyjnej i Angiologii z Pr. Hemodynamiki

    Stalowa Wola, 37-450

  • Szpital Specjalistyczny Św.Jana, Oddział Kardiologii,

    Starogard Gdański, 83-200

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Szczecin, 71-531

  • Poradnia Kardiologiczna

    Tarnów, 33-100

  • Specjalistyczny Gabinet Lekarski Internistyczno-Kardiologiczny-Cardiology

    Tarnów, 33-100

  • Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz", Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną

    Torun, 87 100

  • Oddział Kardiologii Wojewódzki Szpital Zespolony

    Torun, 87-100

  • "Oddział Kardiologiczny Wałbrzyski Ośrodek Kardiologii Interwencyjnej Specjalityczny Szpital im. Dr Alfreda Sokołowskiego

    Wałbrzych, 58-309

  • Oddział Kardiologiczny Szpital Wolski im. dr Anny Gostyńskiej Samodzielny Publiczny Zakład Opieki Zdrowotnej

    Warsaw, 01 - 211

  • Samodzielny Publiczny Centralny Szpital Kliniczny Akademii Medycznej w Warszawie

    Warsaw, 02-097

  • II Klinika Choroby Wieńcowej Instytutu Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego

    Warsaw, 02-637

  • Centrum Leczenia Chorób Cywilizacyjnych

    Warsaw, 02-777

  • Międzyleski Szpital Specjalistyczny w Warszawie

    Warsaw, 04-749

  • NZOZ Starówka

    Warsaw

  • Synexus SCM Sp.z o o.

    Wroclaw, 50-088

  • Niepubliczny Zakład Opieki Zdrowotnej, Centrum Badań Klinicznych

    Wroclaw, 50-349

  • Osrodek Chorob Serca, Klinika Kardiologii 4 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej

    Wroclaw, 50-981

  • "Śląskie Centrum Chorób Serca, III Katedra i Oddział Kliniczny Kardiologii Śląskiego Uniwersytetu Medycznego

    Zabrze, 41-800

Other trials in Poland

Germany50 sites

  • Universitatsklinikum Berlin Campus Charite Mitte Med Klinik Kardiologie und Angiologie

    Berlin, 10117

  • Vivantes Clinic Neuköln Berlin

    Berlin, 12351

  • Vivantes Humbolt Klinikum

    Berlin, 13509

  • Praxis Dr. med. Boscher

    Biberach, 88400

  • St. Josef-Hospital Medizinische Klinik II, Kardiologie

    Bochum, 44791

  • St.-Marien-Hospital Bonn

    Bonn, 53115

  • Städtisches Klinikum Brandenburg GmbH

    Brandenburg, 14770

  • MVZ am Küchwald GmbH

    Chemnitz, 09113

  • Kliniken der Stadt Köln, Köln Merheim

    Cologne, 53109

  • Gemeinschaftspraxis Innere Medizin und Kardiologie

    Dinslaken, 46535

  • St.-Johannes-Hospital Dortmund

    Dortmund, 44137

  • Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR

    Dresden, 1099

  • Practice of Cardiology

    Erfurt, 990804

  • Elisabeth.Krankenhaus

    Essen, 45138

  • Asklepios Klinik St.Georg

    Hamburg, 20099

  • Asklepios Klinik Barmbek

    Hamburg, 22291

  • Universitäres Herz-und Gefäßzentrum Hamburg"

    Hamburg, 22527

  • Kardiologische Praxis Hamburg Altona

    Hamburg, 22765

  • Klinikum Region Hannover Krankenhaus Nordstadt

    Hanover, 30167

  • Kardiologische Gemeinschaftspraxis

    Hartmannsdorf, 09232

  • SRH Klinikum Karlsbad-Langensteinbach

    Karlsbad, 76307

  • Herzzentrum Lahr

    Lahr, 77933

  • Kardiologische Gemeinschaftpraxis

    Leipzig, 04103

  • Universität Leipzig - Herzzentrum

    Leipzig, 04289

  • Dr. THomas Klingenheben

    Lengsdorf, 53127

  • Universitätsklinikum Lübeck

    Lübeck, 23538

  • Praxis für Innere Medizin, Gastroenterologie

    Ludwigshafen, 67067

  • Gemeinschaftspraxis

    Lüneburg, 21339

  • Klinikum der Johannes-Gutenberg-Universität

    Mainz, 55131

  • Gemeinschaftspraxis

    Mannheim, 68165

  • Klinikum Mannheim GmbH, Universaitatskinikum

    Mannheim, 68167

  • Kardiologische Praxis

    Markkleeberg, 04416

  • Asklepios Klinik Melsungen

    Melsungen, 34212

  • Kilniken Maria Hilf GmbH Krankenhaus St. Franziskus

    Mönchengladbach, 41063

  • Internist/Kardiologe/Angiologe

    Mühldorf A.d. Inn, 84453

  • Kardiologische Gemeinschaftspraxis

    Nienburg, 31582

  • Klinikum Pirna GmbH

    Pirna, 01796

  • Universitätsklinik Regensburg

    Regensburg, 93053

  • Krankenhaus Reinbek St. Adolf-Stift

    Reinbek, 21465

  • Kardiologische Gemeinschaftspraxis

    Riesa, 01589

  • Internistische Praxis

    Rottweil, 78628

  • Zentrum für Prävention und Rehabilation

    Siegen, 57072

  • Marienkrankenhaus Soest

    Soest, 59494

  • Praxisgemeinschaft Stuhr-Brinkum

    Stuhr, 28816

  • Medizinische Universitätsklinik

    Tübingen, 72076

  • Josephs-Hospital Warendorf

    Warendorf, 48231

  • Kardiologische Praxis

    Wermsdorf, 04779

  • Dr. Andreas Schreckenberg

    Weyhe-Leeste, 28844

  • ForschungsZentrum Ruhr

    Witten, 58455

  • Helios Klinikum Wuppertal

    Wuppertal, 42117

Other trials in Germany

Canada24 sites

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario, NIR-6V6

  • Recherches Cliniques Theradev

    Granby, Quebec, J2G8Z9

  • ViaCar Recherche Clinique Inc.

    Greenfield Park, Quebec, J4N1L6

  • ViaCar Recherche Clinique Inc

    Longueuil, Quebec, J4N1L6

  • Dr. Tsui

    Maple Ridge, British Columbia, V2X 5Z6

  • Mississauga Clinical Research Center

    Mississauga, Ontario, L5B2P7

  • South East Regional Health Authority

    Moncton, New Brunswick, E1C4B7

  • Hospitalier de l'Universite de Montreal Hotel Dieu

    Montreal, Quebec, H2W 1T8

  • Sacre-Coeur Hospital

    Montreal, Quebec, H4J1C5

  • Commonwealth Medical Clinic

    Mount Pearl, Newfoundland and Labrador, A1N1W7

  • Fraser Clinical Trials Inc and Royal Columbian Hospital

    New Westminster, British Columbia, V3L3W4

  • Dr. George Zimakas

    Niagara Falls, Ontario, L2G5X7

  • Dr. James Y. Cha

    Oshawa, Ontario, L1J2K1

  • Centre Hospitalier Universitaire de Quebec (CHOQ) Hotel Dieu de Quebec

    Québec, Quebec, G1R2J6

  • Laval Hospital

    Québec, Quebec, G1V4G5

  • Centre Hospitalier Beauce-Etchemin

    Saint George, Quebec, G5Y5B7

  • Centre de Sante et de services sociaux du nord de lanaudiere/CHRDL

    Saint-Charles-Borromée, Quebec, J6E6J2

  • Curans Health Center

    Thunder Bay, Ontario, P7R2Z3

  • Toronto East Cardiology Associates Inc.

    Toronto, Ontario, M4C-1N2

  • Clinique de Cardiologie de Trois-Rivieres

    Trois-Rivières, Quebec, G8Z 3R9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R4R2

  • Cardiology and Research

    Westmount, Quebec, H3Z2M6

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A1R9

Other trials in Canada

Bulgaria13 sites

  • Multiprofile Hospital for Active Treatment "Sveta Ekaterina", 1st Department of Internal Diseases

    Dimitrovgrad

  • Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski, Clinic of Cardiology

    Pleven

  • Multiprofile Hospital for Active Treatment ''Sveti Georgi'', Cardiology Clinic

    Plovdiv

  • Multiprofile Hospital for Active Treatment ''Sveti Panteleymon'', 2nd Department. of Internal Diseases - Intensive Cardiology Unit

    Plovdiv

  • Multiprofile Hospital for Active Treatment - Ruse, 4th Department of Internal Diseases

    Rousse

  • 4th Multiprofile Hospital for Active Treatment

    Sofia

  • Military Medical Academy, Clinic of Cardiology and Intensive Care

    Sofia

  • Multiprofile Hospital for Active Treatment and Emergency Medicine "Pirogov". Cardiology Clinic

    Sofia

  • National Heart Hospital Department of Cardiology

    Sofia

  • National Multiprofile Transport Hospital "Tsar Boris III, Cardiology Clinic

    Sofia

  • Tokuda Hospital Department of Cardiology

    Sofia

  • University Multiprofile Hospital for Active Treatment ''Tsaritsa Ioanna'' - ISUL, Cardiology Clinic

    Sofia

  • Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Internal Diseases - 2nd Internal Department

    Varna

Other trials in Bulgaria

Australia12 sites

  • Wesley research institute

    Auchenflower, Queensland, 4066

  • Cairns Base Hospital

    Cairns, Queensland, 4870

  • Coffs Harbour Cardiology

    Coffs Harbour, New South Wales, 2450

  • Cardiac Research Institute

    Eastwood, New South Wales, 2122

  • Northern Hospital

    Epping, Victoria, 3076

  • St.Vincent's Hospital (Melb)

    Fitzroy, Victoria, 3065

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Geelong Hospital- Barwon Health

    Geelong, Victoria, 3220

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7001

  • Launceston General Hospital

    Launceston, Tasmania, 7250

Other trials in Australia

Czechia11 sites

  • Nemocnice ve Frydku-Mistku

    Frýdek-Místek, 738 18

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Krajska nemocnice Liberec, a. s.

    Liberec, 460 63

  • Litomyslska nemocnice a. s.

    Litomyšl, 570 14

  • Kardiologická ambulance

    Ostrava, 702 00

  • Kardiologicka a angiologicka ambulance

    Ostrava Vítkovice, 703 00

  • Pardubicka krajska nemocnice, a.s.

    Pardubice, 532 03

  • II.interni klinika kardiologie a angiologie 1. LF UK a VFN v Praze

    Prague, 12808

  • Klinika kardiologie Institut klinické a experimentální medicíny

    Prague, 140 21

  • Krajská nemocnice T. Bati a.s.

    Zlín, 762 75

  • Nemocnice Znojmo, p.o.

    Znojmo, 669 02

Other trials in Czechia

Slovakia11 sites

  • Novamed s.r.o.

    Banská Bystrica, 97405

  • Alian s.r.o.

    Bardejov, 085-01

  • 5. Interna klinika LF UK, FNsP Bratislava, Nemocnica Ruzinov

    Bratislava, 826 06

  • Cardio D&R spol. s r.o.

    Košice, 040-22

  • Kardiomed s.r.o.

    Lučenec, 98401

  • NZZ Kardiocentrum Nitra s.r.o.

    Nitra, 950-01

  • MUDr. Tibor DURIS, CSc., s.r.o.

    Nové Zámky, 94052

  • Nemocnica s poliklinikou Považská Bystrica

    Považská Bystrica, 017 26

  • Fakultna Nemocnica Trencin

    Trenčín, 911 71

  • Žilpo s.r.o.

    Žilina, 010 01

  • Medivasa s.r.o.

    Žilina, 010-01

Other trials in Slovakia

Chile10 sites

  • Clinica Antofagasta

    Antofagasta

  • Corporación de Beneficencia Osorno

    Osorno

  • Hospital Regional de Punta Arenas Dr. Lautaro Navarro

    Punta Arenas

  • Complejo Asistencial Dr.Sótero del Río

    Santiago, 8207257

  • Hospital del Salvador

    Santiago

  • Instituto Nacional del Tórax

    Santiago

  • Centro de Estudios Cardiovascular

    Temuco

  • Clínica Reñaca

    Viña del Mar

  • Hospital Dr. Gustavo Fricke

    Viña del Mar

  • Hospital Naval Almirante Neff

    Viña del Mar

Other trials in Chile

Romania10 sites

  • Spitalul Clinic Judetean de Urgenta Bacau

    Bacau, 600114

  • S.C. Duo Medical S.R.L.

    Bucharest, 010584

  • Centrul Medical SANA

    Bucharest, 011025

  • Cardiomed SRL

    Bucharest, 020506

  • Institutul Inimii "Niculae Stanicioiu"

    Cluj-Napoca, 400001

  • Cardiomed SRL

    Craiova, 200147

  • Dr. C.I. Parhon Hospital

    Iași, 700503

  • Clinical county Hospital

    Sibiu, 550245

  • Institutul de Boli Cardiovasculare si Transplan Tg. Mures

    Târgu Mureş, 540136

  • County Hospital

    Timișoara, 300736

Other trials in Romania

France9 sites

  • Centre Hospitalier d'Albi

    Albi, 81000

  • Centre de Cardiologie CHRU Dijon

    Dijon, 21079

  • Clinique Pasteur

    Essey-lès-Nancy, 54270

  • CHRU de Lille Hôpital Cardiologique

    Lille, 59037

  • Hôpital La Timone-Adultes

    Marseille, 13385

  • Hôpital Lariboisière

    Paris, 75010

  • La Pitié Salpétrière Institut de Cardiologie

    Paris, 75651

  • Centre Hospitalier Intercommunal du Val d'Ariège

    Saint-Jean-de-Verges, 09000

  • Centre Hospitalier Rangueil Larrey

    Toulouse, 31403

Other trials in France

Hungary9 sites

  • Bajai Kórház

    Baja, H-6500

  • Budai Irgalmasrendi Kórház

    Budapest, H-1027

  • Fővárosi Önkormányzat Károlyi Sándor Kórház és Rendelőintézet

    Budapest, H-1041

  • Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet

    Budapest, H-1096

  • Városi Önkormányzat Kórház-Rendelőintézet

    Kalocsa, H-6300

  • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház

    Nyíregyháza, H-4400

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház

    Toszegi, H-5004

  • Jávorszky Ödön Kórház

    Vác, H-2600

  • Zala Megyei Kórház

    Zalaegerszeg, H-8900

Other trials in Hungary

Mexico9 sites

  • Hospital Cardiológica Aguascalientes

    Aguascalientes, 20230

  • Hospital de Jesus

    D. F., D. F., cp 06090

  • Cardioprevent

    Durango, C. P 34080

  • Hospital "Valentín Gómez Farías"

    Guadalajara, Jalisco, 44600

  • Hospital Angeles de Puebla

    Puebla City, 72190'

  • Hospital General de Puebla

    Puebla City, 72490

  • Instituto de Corazón de Querétaro, S.A. de C.V.

    Querétaro City, Querétaro, 76178

  • Cardioarritmias e Investigación, S.C.

    San Luis Potosí City, San Lusi Potosi, 78200

  • Hospital Central "Dr. Ignacio Morones Prieto"

    San Luis Potosí City, 78240

Other trials in Mexico

Ukraine7 sites

  • "Klinichne obyednannia shvydkoi medychnoi dopomogy, m. Dnipropetrovs'k,Dnipropetrovs'ka derzhavna medychna akademiya, kafedra gospital'noi terapii #2

    Dnipropetrovsk, 49006

  • Oblasnyi klinichnyi kardiologichnyi dyspanser, m. Ivano-Frankivsk, Ivano-Frankivskyi derzhavnyi medychnyi universytet, kafedra terapii # 3

    Ivano-Frankivsk, 76005

  • TOV "Kardiologichna klinika "Sertse i sudyny" m. Kyiv

    Kyiv, 1032

  • Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska" AMN Ukrainy, m. Kyiv, viddilenia symptomatychnykh arterial'nykh gipertenziy

    Kyiv, 3680

  • Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska", viddil reanimatsii ta intensyvnoi terapii, m. Kyiv

    Kyiv, 3680

  • Komunal'na ustanova "Oblasnyi kardiologichnyi dyspanser", viddilenia intensyvnoi terapii, m. Zaporizhzhia

    Zaporizhzhya, 69000

  • Kardioarytmologichnyi tsentr Zhytomyrs'koi oblasnoi klinichnoi likarni im. O.F. Gorbachevs'kogo, m. Zhytomyr

    Zhytomyr, 10002

Other trials in Ukraine

Italy6 sites

  • Ospedali Riuniti di bergamo

    Bergamo, 24128

  • Azienda Ospedaliera della Provincia di Lodi Presidio Ospedaliero di Codogno

    Codogno (Lodi), 26845

  • Azienda Ospedaliera Universitaria San Martino-Dipartimento di Medicina Interna e Specialità Mediche

    Genova, 16132

  • Azienda Ospeedaliera Carlo Poma

    Mantua, 46100

  • Azienda Ospedaliera Maggiore Della Carita' Di Novara

    Novara, 28100

  • Istituto Clinico Humanitas

    Rozzano (Milano), 20089

Other trials in Italy

Puerto Rico1 site

  • Research and Cardiovascular Corp.

    Ponce, 00717-1322

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease

The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy.

Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens.

Read more

The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease.

Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events.

Being tested
CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin, Plavix (clopidogrel 75 mg) and aspirin
Keywords
ACS, CAD, MI, PCI, PTCA, NSTEMI, STEMI, acute coronary syndrome, cerebrovascular disorders, coronary artery stent placement, coronary thrombosis, myocardial infarction, myocardial ischemia, percutaneous coronary intervention, percutaneous transluminal coronary angioplasty, peripheral vascular diseases, duodenal obstruction, duodenal ulcer, dyspepsia, esophagitis, peptic
Medical subject headings
Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery Disease, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Cerebrovascular Disorders, Coronary Thrombosis, Myocardial Ischemia

What participants receive

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

  • CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirinDrug

    (CGT-2168 active and Comparator placebo, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)

  • Plavix (clopidogrel 75 mg) and aspirinDrug

    (CGT-2168 placebo and Comparator active, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)

Study groups in NCT00557921
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin
2Active comparatorNot described
Receives: Drug: Plavix (clopidogrel 75 mg) and aspirin

What is being measured

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

  1. Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation

    Measured: Anticipated minimum of 48 weeks, up to end of study

Secondary outcomes (6)

  1. Composite of gastroduodenal bleeding, symptomatic gastroduodenal ulcer, obstruction or perforation

    Measured: Anticipated minimum of 48 weeks, up to end of study

  2. Composite of gastroduodenal bleeding, obstruction or perforation

    Measured: Anticipated minimum of 48 weeks, up to end of study

  3. Discontinuation of study medication attributed to gastrointestinal signs or symptoms

    Measured: Anticipated minimum of 48 weeks, up to end of study

  4. Gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis

    Measured: Anticipated minimum of 48 weeks, up to end of study

  5. Dyspepsia, defined as an increase of at least ten points on the "pain intensity" component of the SODA instrument from baseline

    Measured: Anticipated minimum of 48 weeks, up to end of study

  6. Occurrence of a cardiovascular event (cardiovascular death, nonfatal myocardial infarction, CABG or PCI, or confirmed ischemic stroke

    Measured: Anticipated minimum of 48 weeks, up to end of study

Timeline

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

  1. First posted14 Nov 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionNov 2009 (estimated)
  4. Study completionNov 2009 (estimated)

Why it stopped: Terminated by Sponsor

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00557921
Sponsor's protocol ID
CG104
Other IDs
EudraCT 2007-005891-15
Acronym
COGENT-1
Status last verified
Jan 2009
First submitted
12 Nov 2007
Last updated
28 Jan 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Vaduganathan M, Bhatt DL, Cryer BL, Liu Y, Hsieh WH, Doros G, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Cannon CP; COGENT Investigators. Proton-Pump Inhibitors Reduce Gastrointestinal Events Regardless of Aspirin Dose in Patients Requiring Dual Antiplatelet Therapy. J Am Coll Cardiol. 2016 Apr 12;67(14):1661-71. doi: 10.1016/j.jacc.2015.12.068. Epub 2016 Mar 21.

    PubMed 27012778

  • Bhatt DL, Cryer BL, Contant CF, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Scirica BM, Murphy SA, Cannon CP; COGENT Investigators. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010 Nov 11;363(20):1909-17. doi: 10.1056/NEJMoa1007964. Epub 2010 Oct 6.

    PubMed 20925534

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin and Plavix (clopidogrel 75 mg) and aspirin in people with Acute Coronary Syndrome and Myocardial Infarction, run by Cogentus Pharmaceuticals at 491 sites in 16 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 3 inclusion and 17 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: stopped early, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 491 sites in United States, Poland, Germany, Canada, Bulgaria and 11 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?

The study was stopped early (reason given: Terminated by Sponsor). Results are not available in the source record.

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?

Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation (time frame: Anticipated minimum of 48 weeks, up to end of study). 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 NCT00557921, which also lists 2 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 28 Jan 2009.

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