AzTrials
AzTrials

Acute Coronary SyndromePhase 3NCT00809965

An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

A Phase 3 study testing Rivaroxaban 2.5 mg and Rivaroxaban 5 mg in people with Acute Coronary Syndrome and Myocardial Infarction, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 556 sites in 43 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rivaroxaban 2.5 mg and Rivaroxaban 5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15,526 participants
Where
556 sitesin 43 countries
Study dates
Nov 2008to Sep 2011
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

  • Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation
  • Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital

Who cannot join

  • Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
  • Need for continued anticoagulant therapy
  • Significant renal impairment or known significant liver disease

Trial locations and contacts

556 sites in 43 countries.

556 sites in 43 countries

United States73 sites

  • Study site

    Amarillo, Texas

  • Study site

    Anaheim, California

  • Study site

    Aurora, Colorado

  • Study site

    Aurora, Illinois

  • Study site

    Bartlesville, Oklahoma

  • Study site

    Bethesda, Maryland

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Bridgewater, New Jersey

  • Study site

    Buffalo, New York

  • Study site

    Burbank, California

  • Study site

    Burlington, Vermont

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Georgia

  • Study site

    Columbus, Ohio

  • Study site

    Cortlandt Manor, New York

  • Study site

    Danville, Virginia

  • Study site

    Dayton, Ohio

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Fairview Park, Ohio

  • Study site

    Flint, Michigan

  • Study site

    Geneva, Alabama

  • Study site

    Grand Blanc, Michigan

  • Study site

    Grand Rapids, Michigan

  • Study site

    Greenville, South Carolina

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Johnson City, Tennessee

  • Study site

    Jupiter, Florida

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kalispell, Montana

  • Study site

    Kissimmee, Florida

  • Study site

    Lacombe, Louisiana

  • Study site

    Langhorne, Pennsylvania

  • Study site

    Linden, New Jersey

  • Study site

    Littleton, Colorado

  • Study site

    Los Angeles, California

  • Study site

    Lubbock, Texas

  • Study site

    Memphis, Tennessee

  • Study site

    Merrillville, Indiana

  • Study site

    Miami, Florida

  • Study site

    Mission Hills, California

  • Study site

    Mobile, Alabama

  • Study site

    Mount Clemens, Michigan

  • Study site

    Munster, Indiana

  • Study site

    Ocala, Florida

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orlando, Florida

  • Study site

    Ormond Beach, Florida

  • Study site

    Overland Park, Kansas

  • Study site

    Petoskey, Michigan

  • Study site

    Ridley Park, Pennsylvania

  • Study site

    Roanoke, Virginia

  • Study site

    Rome, Georgia

  • Study site

    Salt Lake City, Utah

  • Study site

    San Diego, California

  • Study site

    Saratoga Springs, New York

  • Study site

    Sayre, Pennsylvania

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Stony Brook, New York

  • Study site

    Syracuse, New York

  • Study site

    Tomball, Texas

  • Study site

    Tupelo, Mississippi

  • Study site

    Valparaiso, Indiana

  • Study site

    Wausau, Wisconsin

  • Study site

    West Chester, Pennsylvania

  • Study site

    Wichita, Kansas

  • Study site

    Winston-Salem, North Carolina

  • Study site

    York, Pennsylvania

Other trials in United States

Japan38 sites

  • Study site

    Anan

  • Study site

    Fukui

  • Study site

    Fukuoka

  • Study site

    Fukuyama

  • Study site

    Gifu

  • Study site

    Higashiosaka

  • Study site

    Kagoshima

  • Study site

    Kanazawa

  • Study site

    Kasuga

  • Study site

    Kawachi-Nagano

  • Study site

    Kawasaki

  • Study site

    Kisarazu

  • Study site

    Kobe

  • Study site

    Kumamoto

  • Study site

    Kuwana

  • Study site

    Maebashi-City Gunma

  • Study site

    Matsudo

  • Study site

    Matsumoto

  • Study site

    Matsuyama-City Ehime

  • Study site

    Miyazaki-Gun

  • Study site

    Nagano

  • Study site

    Nagasaki

  • Study site

    Nagoya

  • Study site

    Namegata

  • Study site

    Nankoku

  • Study site

    Nishinomiya

  • Study site

    Okayama

  • Study site

    Osaka

  • Study site

    Sakaidechō

  • Study site

    Sakura-Shi

  • Study site

    Suwa

  • Study site

    Tokushima

  • Study site

    Tokyo

  • Study site

    Toyama

  • Study site

    Urasoe

  • Study site

    Yamaguchi

  • Study site

    Yokohama

  • Study site

    Yonago-Shi

Other trials in Japan

Russia32 sites

  • Study site

    Arkhangelsk

  • Study site

    Barnaul

  • Study site

    Chelyabinsk

  • Study site

    Ivanovo

  • Study site

    Kaliningrad

  • Study site

    Kemerovo

  • Study site

    Kirov

  • Study site

    Krasnodar

  • Study site

    Krasnoyarsk

  • Study site

    Kursk

  • Study site

    Lyubertsy

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Novosibirsk

  • Study site

    Omsk

  • Study site

    Orenburg

  • Study site

    Penza

  • Study site

    Perm

  • Study site

    Pskov

  • Study site

    Pushkin, Saint-Petersburg

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Saint-Petersbrug

  • Study site

    Sestroretsk, Saint-Petersburg

  • Study site

    Syktyvkar

  • Study site

    Tomsk

  • Study site

    Tula

  • Study site

    Tumen Region

  • Study site

    Vladimir

  • Study site

    Voronezh

  • Study site

    Yaroslavl Nap

  • Study site

    Yekaterinburg

Other trials in Russia

India29 sites

  • Study site

    Ahmedabad

  • Study site

    Allahabād

  • Study site

    Bangalore

  • Study site

    Chandigarh

  • Study site

    Chennai

  • Study site

    Coimbatore

  • Study site

    Ernākulam

  • Study site

    Gandhinagar Guiarat

  • Study site

    Gūrgaon

  • Study site

    Hyderabad

  • Study site

    Jaipur

  • Study site

    Karamsad

  • Study site

    Kochi

  • Study site

    Kolkata

  • Study site

    Lucknow Gpo

  • Study site

    Ludhiana

  • Study site

    Madurai

  • Study site

    Mangalore

  • Study site

    Mumbai

  • Study site

    Mysore

  • Study site

    Nagpur

  • Study site

    Nashik

  • Study site

    New Delhi

  • Study site

    Pune

  • Study site

    Surat

  • Study site

    Trissur

  • Study site

    Trivandrum

  • Study site

    Vadodara

  • Study site

    Vijayawada

Other trials in India

Poland26 sites

  • Study site

    Będzin

  • Study site

    Bialystok

  • Study site

    Bielsko-Biala

  • Study site

    Bydgoszcz

  • Study site

    Bytom

  • Study site

    Dąbrowa Górnicza

  • Study site

    Gdynia

  • Study site

    Gorlice

  • Study site

    Katowice

  • Study site

    Katowice-Ochojec

  • Study site

    Koszalin

  • Study site

    Krakow

  • Study site

    Kutno

  • Study site

    Lodz

  • Study site

    Nowy Targ

  • Study site

    Opole

  • Study site

    Płock

  • Study site

    Poznan

  • Study site

    Ruda Śląska

  • Study site

    Starogard Gdanski Nap

  • Study site

    Szczecin

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Włocławek

  • Study site

    Wroclaw

  • Study site

    Zamość

Other trials in Poland

Germany23 sites

  • Study site

    Bad Friedrichshall

  • Study site

    Berlin

  • Study site

    Bonn

  • Study site

    Dresden

  • Study site

    Essen

  • Study site

    Esslingen am Neckar

  • Study site

    Frankfurt am Main

  • Study site

    Freiburg im Breisgau

  • Study site

    Göttingen

  • Study site

    Greifswald

  • Study site

    Halle

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Heidelberg

  • Study site

    Kiel

  • Study site

    Leipzig

  • Study site

    Limburg

  • Study site

    Lübeck

  • Study site

    Magdeburg

  • Study site

    Mannheim

  • Study site

    Weiden

  • Study site

    Wermsdorf

  • Study site

    Witten

Other trials in Germany

Canada19 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Granby, Quebec

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Kelowna, British Columbia

  • Study site

    Laval

  • Study site

    London, Ontario

  • Study site

    Maple Ridge, British Columbia

  • Study site

    Montreal, Quebec

  • Study site

    Newmarket, Ontario

  • Study site

    North Battleford, Saskatchewan

  • Study site

    Oshawa, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Saint-Charles-Borromée, Quebec

  • Study site

    Saint-Georges, Quebec

  • Study site

    Sherbrooke, Quebec

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Ste-Foy, Quebec

  • Study site

    Victoria, British Columbia

Other trials in Canada

Czechia18 sites

  • Study site

    Benešov nad Černou

  • Study site

    Brno

  • Study site

    České Budějovice

  • Study site

    Český Krumlov

  • Study site

    Hradec Králové

  • Study site

    Kolín

  • Study site

    Kroměříž

  • Study site

    Litomyšl

  • Study site

    Náchod

  • Study site

    Pardubice

  • Study site

    Plzeò 1

  • Study site

    Poruba

  • Study site

    Prague

  • Study site

    Praha 10 N/A

  • Study site

    Slaný

  • Study site

    Teplice

  • Study site

    Ústí nad Labem

  • Study site

    Znojmo

Other trials in Czechia

Ukraine18 sites

  • Study site

    Cherkassy

  • Study site

    Dnipro

  • Study site

    Donetsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Khemelnitskiy

  • Study site

    Kiev

  • Study site

    Luhansk

  • Study site

    Lutsk

  • Study site

    Lviv

  • Study site

    Mykolayiv

  • Study site

    Poltava

  • Study site

    Sumy

  • Study site

    Ternopil

  • Study site

    Uzhhorod

  • Study site

    Vinnitsa

  • Study site

    Zaporizhzhya

  • Study site

    Zhytomyr

Other trials in Ukraine

United Kingdom18 sites

  • Study site

    Birmingham

  • Study site

    Blackpool

  • Study site

    Bristol

  • Study site

    Chertsey

  • Study site

    Chesterfield

  • Study site

    East Sussex

  • Study site

    Exeter

  • Study site

    Hampshire

  • Study site

    Harrow

  • Study site

    Hull

  • Study site

    Leicester

  • Study site

    Lincoln

  • Study site

    Manchester

  • Study site

    Middlesbrough

  • Study site

    Portadown

  • Study site

    Stockport

  • Study site

    Warwick

  • Study site

    Worcester

Other trials in United Kingdom

Spain16 sites

  • Study site

    Alicante

  • Study site

    Aviles Asturias

  • Study site

    Barcelona

  • Study site

    Burgos

  • Study site

    Elche

  • Study site

    Figueres

  • Study site

    Guadalajara

  • Study site

    Huelva

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Salamanca

  • Study site

    Santander

  • Study site

    Seville

  • Study site

    Tarragona

  • Study site

    Valencia

  • Study site

    Vigo

Other trials in Spain

Australia15 sites

  • Study site

    Bedford Park

  • Study site

    Chermside

  • Study site

    Coffs Harbour South

  • Study site

    Douglas

  • Study site

    Epping

  • Study site

    Fremantle

  • Study site

    Heidelberg

  • Study site

    Herston

  • Study site

    Launceston

  • Study site

    Milton

  • Study site

    Newcastle

  • Study site

    Parkville

  • Study site

    Perth

  • Study site

    Southport

  • Study site

    Woolloongabba

Other trials in Australia

Netherlands14 sites

  • Study site

    Amsterdam

  • Study site

    Arnhem

  • Study site

    Delft

  • Study site

    Eindhoven

  • Study site

    Gorinchem

  • Study site

    Gouda

  • Study site

    Haarlem

  • Study site

    Harderwijk

  • Study site

    Hengelo Ov

  • Study site

    Nieuwegein

  • Study site

    Nijmegen

  • Study site

    Sittard

  • Study site

    The Hague

  • Study site

    Vlaardingen

Other trials in Netherlands

Argentina13 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    Corrientes

  • Study site

    Junín

  • Study site

    La Plata

  • Study site

    Mar del Plata

  • Study site

    Morón

  • Study site

    Resistencia

  • Study site

    Rosario

  • Study site

    Salta

  • Study site

    San Luis

  • Study site

    San Miguel de Tucumán

  • Study site

    Santa Fe

Other trials in Argentina

China13 sites

  • Study site

    Beijing

  • Study site

    Beijing Prc

  • Study site

    Changsha

  • Study site

    Daqing

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Harbin

  • Study site

    Jinan

  • Study site

    Nanjing

  • Study site

    Shanghai

  • Study site

    Shenyang

  • Study site

    Tianjin

  • Study site

    Xi'an

Other trials in China

Mexico13 sites

  • Study site

    Aguascalientes

  • Study site

    Cd. Juarez

  • Study site

    Culiacán

  • Study site

    Guadalajara

  • Study site

    León

  • Study site

    México

  • Study site

    Mexico City

  • Study site

    Monterrey

  • Study site

    Querétaro

  • Study site

    San Luis Potosí City

  • Study site

    Sinaloa

  • Study site

    Veracruz

  • Study site

    Zapopan

Other trials in Mexico

Brazil12 sites

  • Study site

    Belo Horizonte

  • Study site

    Blumenau

  • Study site

    Campina Grande do Sul

  • Study site

    Campinas

  • Study site

    Curitiba

  • Study site

    Porto Alegre

  • Study site

    Recife

  • Study site

    Ribeirão Preto

  • Study site

    Rio de Janeiro

  • Study site

    Salvador

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

Other trials in Brazil

Chile12 sites

  • Study site

    Antofagasta

  • Study site

    Chile

  • Study site

    Osorno X Región

  • Study site

    Punta Arenas

  • Study site

    San Bernardo

  • Study site

    Santiago

  • Study site

    Santiago Rm

  • Study site

    Talcahuano

  • Study site

    Temuco

  • Study site

    Valdivia X Región

  • Study site

    Victoria

  • Study site

    Viña del Mar

Other trials in Chile

France12 sites

  • Study site

    Besançon

  • Study site

    Cannes

  • Study site

    Chambray-lès-Tours

  • Study site

    Chartres

  • Study site

    Créteil

  • Study site

    Dijon

  • Study site

    Haguenau

  • Study site

    Lagny

  • Study site

    Marseille

  • Study site

    Montfermeil

  • Study site

    Paris

  • Study site

    Poitiers

Other trials in France

Bulgaria11 sites

  • Study site

    Burgas

  • Study site

    Dimitrovgrad

  • Study site

    Haskovo

  • Study site

    Pazardzhik

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Rousse

  • Study site

    Sevlievo

  • Study site

    Sofia

  • Study site

    Varna

  • Study site

    Veliko Tarnovo

Other trials in Bulgaria

Israel10 sites

  • Study site

    Afula

  • Study site

    Hadera

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Nahariya

  • Study site

    Petah Tikva

  • Study site

    Rehovot

  • Study site

    Safed

  • Study site

    Tel Aviv

  • Study site

    Tiberias

Other trials in Israel

Hungary9 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Győr

  • Study site

    Kecskemét

  • Study site

    Komárom

  • Study site

    Miskolc

  • Study site

    Szolnok

  • Study site

    Szombathely

  • Study site

    Zalaegerszeg

Other trials in Hungary

Portugal9 sites

  • Study site

    Aveiro

  • Study site

    Braga

  • Study site

    Coimbra

  • Study site

    Faro

  • Study site

    Leiria

  • Study site

    Lisbon

  • Study site

    Penafiel

  • Study site

    Porto

  • Study site

    Vila Nova de Gaia

Other trials in Portugal

Sweden9 sites

  • Study site

    Danderyd

  • Study site

    Gothenburg

  • Study site

    Jönköping

  • Study site

    Linköping

  • Study site

    Lund

  • Study site

    Malmö

  • Study site

    Örebro

  • Study site

    Östersund

  • Study site

    Umeå

Other trials in Sweden

Turkey (Türkiye)9 sites

  • Study site

    Ankara

  • Study site

    Aydin

  • Study site

    Bursa

  • Study site

    Erzurum

  • Study site

    Istanbul

  • Study site

    Izmir

  • Study site

    Kayseri

  • Study site

    Samsun

  • Study site

    Sivas

Other trials in Turkey (Türkiye)

Belgium8 sites

  • Study site

    Bonheiden

  • Study site

    Brussels

  • Study site

    Eupen

  • Study site

    Genk

  • Study site

    Huy

  • Study site

    Leuven

  • Study site

    Mol

  • Study site

    Tienen

Other trials in Belgium

Colombia8 sites

  • Study site

    Armenia

  • Study site

    Barranquilla

  • Study site

    Bogotá Dc

  • Study site

    Cali Valle Del Cauca

  • Study site

    Envigado

  • Study site

    Manizales

  • Study site

    Medellín

  • Study site

    Santander

Other trials in Colombia

Denmark7 sites

  • Study site

    Aalborg

  • Study site

    Copenhagen

  • Study site

    Esbjerg

  • Study site

    Holbæk

  • Study site

    Horsens

  • Study site

    Kolding

  • Study site

    Odense

Other trials in Denmark

Romania7 sites

  • Study site

    Bucharest

  • Study site

    Craiova

  • Study site

    Focşani

  • Study site

    Oradea

  • Study site

    Piteşti

  • Study site

    Tg Mures

  • Study site

    Timișoara

Other trials in Romania

New Zealand6 sites

  • Study site

    Auckland

  • Study site

    Dunedin

  • Study site

    Hamilton

  • Study site

    Lower Hutt

  • Study site

    Nelson

  • Study site

    New Plymouth

Other trials in New Zealand

Lithuania5 sites

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Šiauliai

  • Study site

    Vilnius

  • Study site

    Vilnius Lt

Other trials in Lithuania

Malaysia5 sites

  • Study site

    Johor Bahru

  • Study site

    Kelantan

  • Study site

    Kota Samarahan

  • Study site

    Kuala Lumpur

  • Study site

    Selayang Baru Utara

Other trials in Malaysia

South Korea5 sites

  • Study site

    Daejeon

  • Study site

    Gwangju

  • Study site

    Seognam-Si, Kyungki-Do

  • Study site

    Seoul

  • Study site

    Suwon

Other trials in South Korea

Egypt4 sites

  • Study site

    Alexandria

  • Study site

    Cairo

  • Study site

    Ismailia

  • Study site

    Menofeya

Other trials in Egypt

Greece4 sites

  • Study site

    Athens

  • Study site

    Larissa

  • Study site

    Rhodes

  • Study site

    Thessalonikis

Other trials in Greece

Serbia4 sites

  • Study site

    Belgrade

  • Study site

    Kragujevac

  • Study site

    Niš

  • Study site

    Niška Banja

Other trials in Serbia

Thailand4 sites

  • Study site

    Bangkok

  • Study site

    Chiang Mai

  • Study site

    Pathum Thani

  • Study site

    Phathumwan

Other trials in Thailand

Croatia3 sites

  • Study site

    Rijeka

  • Study site

    Slavonski Brod

  • Study site

    Suska 6

Other trials in Croatia

Latvia3 sites

  • Study site

    Daugavpils

  • Study site

    Liepāja

  • Study site

    Riga

Other trials in Latvia

Morocco3 sites

  • Study site

    Marrakesh

  • Study site

    Meknes

  • Study site

    Rabat

Other trials in Morocco

Philippines3 sites

  • Study site

    Iloilo City

  • Study site

    Marikina City

  • Study site

    Quezon City

Other trials in Philippines

Slovakia3 sites

  • Study site

    Bratislava

  • Study site

    Nové Zámky

  • Study site

    Žilina

Other trials in Slovakia

Tunisia3 sites

  • Study site

    Sfax

  • Study site

    Sousse

  • Study site

    Tunis

Other trials in Tunisia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome

The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

Read the detailed description

Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS. Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.

Being tested
Rivaroxaban 2.5 mg, Rivaroxaban 5 mg, Placebo, Standard of care
Keywords
Rivaroxaban, Acute Coronary Syndrome, ACS, Aspirin, Thienopyridine, Unstable Angina, Myocardial Infarction, Anticoagulation, Clopidogrel (Plavix)
Medical subject headings
Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia, Angina, Unstable

What participants receive

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

  • Rivaroxaban 2.5 mgDrug

    One tablet twice daily

  • Rivaroxaban 5 mgDrug

    One tablet twice daily

  • PlaceboDrug

    One placebo tablet twice daily

  • Standard of careDrug

Study groups in NCT00809965
Study groupRoleWhat they receive
Rivaroxaban 2.5 mg bidExperimentalOne 2.5 mg rivaroxaban tablet twice daily for up to 6 months
Receives: Drug: Rivaroxaban 2.5 mg; Drug: Standard of care
Rivaroxaban 5 mg bidExperimentalOne 5 mg rivaroxaban tablet twice daily for up to 6 months
Receives: Drug: Rivaroxaban 5 mg; Drug: Standard of care
PlaceboPlacebo comparatorOne placebo tablet twice daily for up to 6 months
Receives: Drug: Placebo; Drug: Standard of care

What is being measured

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

  1. The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke

    The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.

    Measured: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)

Secondary outcomes (4)

  1. The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke

    The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.

    Measured: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)

  2. The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery

    The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.

    Measured: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)

  3. The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization

    The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.

    Measured: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)

  4. The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization

    The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.

    Measured: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)

Timeline

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

  1. First posted17 Dec 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionSep 2011
  4. Study completionSep 2011

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15,526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00809965
Sponsor's protocol ID
CR014710
Other IDs
RIVAROXACS3001
Status last verified
Aug 2014
First submitted
16 Dec 2008
Last updated
17 Sep 2014
Data monitoring committee
Yes

Publications

  • Chi G, AlKhalfan F, Lee JJ, Montazerin SM, Fitzgerald C, Korjian S, Omar W, Barnathan E, Plotnikov A, Gibson CM. Factors associated with early, late, and very late stent thrombosis among patients with acute coronary syndrome undergoing coronary stent placement: analysis from the ATLAS ACS 2-TIMI 51 trial. Front Cardiovasc Med. 2024 Jan 8;10:1269011. doi: 10.3389/fcvm.2023.1269011. eCollection 2023.

    PubMed 38259304

  • Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.

    PubMed 31535314

  • Gibson CM, Levitan B, Gibson WJ, Yee MK, Murphy SA, Yuan Z, Chakrabarti AK, Lee M, Braunwald E. Fatal or Irreversible Bleeding and Ischemic Events With Rivaroxaban in Acute Coronary Syndrome. J Am Coll Cardiol. 2018 Jul 10;72(2):129-136. doi: 10.1016/j.jacc.2018.04.055.

    PubMed 29976285

  • Cavender MA, Gibson CM, Braunwald E, Wiviott SD, Murphy SA, Toda Kato E, Plotnikov AN, Amuchastegui M, Oude Ophuis T, van Hessen M, Mega JL. The effect of rivaroxaban on myocardial infarction in the ATLAS ACS 2 - TIMI 51 trial. Eur Heart J Acute Cardiovasc Care. 2015 Oct;4(5):468-74. doi: 10.1177/2048872614554109. Epub 2014 Oct 15.

    PubMed 25318481

  • Gibson CM, Chakrabarti AK, Mega J, Bode C, Bassand JP, Verheugt FW, Bhatt DL, Goto S, Cohen M, Mohanavelu S, Burton P, Stone G, Braunwald E; ATLAS-ACS 2 TIMI 51 Investigators. Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS 2 TIMI 51. J Am Coll Cardiol. 2013 Jul 23;62(4):286-90. doi: 10.1016/j.jacc.2013.03.041. Epub 2013 Apr 16.

    PubMed 23602776

  • Mega JL, Braunwald E, Murphy SA, Plotnikov AN, Burton P, Kiss RG, Parkhomenko A, Tendera M, Widimsky P, Gibson CM. Rivaroxaban in patients stabilized after a ST-segment elevation myocardial infarction: results from the ATLAS ACS-2-TIMI-51 trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction-51). J Am Coll Cardiol. 2013 May 7;61(18):1853-9. doi: 10.1016/j.jacc.2013.01.066. Epub 2013 Mar 7.

    PubMed 23500262

  • Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, Verheugt FW, Gibson CM; ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19. doi: 10.1056/NEJMoa1112277. Epub 2011 Nov 13.

    PubMed 22077192

  • Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6. doi: 10.1016/j.ahj.2011.01.026.

    PubMed 21570509

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban 2.5 mg and Rivaroxaban 5 mg in people with Acute Coronary Syndrome and Myocardial Infarction, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 556 sites in 43 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 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 556 sites in United States, Japan, Russia, India, Poland and 38 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. Some participants in this study may receive a placebo. 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 2 Jun 2014). 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?

The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke (time frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)). 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 NCT00809965, which also lists 8 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 17 Sep 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in