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Acute Coronary SyndromePhase 2GEMINI ACS 1NCT02293395

A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome

A Phase 2 study testing Acetylsalicylic acid, Rivaroxaban and Clopidogrel in people with Acute Coronary Syndrome, run by Janssen Research & Development, LLC at 259 sites in 20 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 estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Acetylsalicylic acid, Rivaroxaban and Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,037 participants
Where
259 sitesin 20 countries
Study dates
20 Apr 2015to 14 Oct 2016
Phase
Phase 2
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

  • Participants, 18 years or older, must have symptoms suggestive of acute coronary syndrome (ACS) (angina, or symptoms thought to be equivalent) within 48 hours of hospital presentation, or developed ACS while being hospitalized, and has a diagnosis of: a) ST segment elevation myocardial infarction (STEMI); b) non-ST-segment elevation acute coronary syndrome (NSTE-ACS). However, participant who is 54 years of age or younger must also have either diabetes mellitus or a history of a prior myocardial infarction (MI), in addition to the presenting ACS event
  • Participant must be randomized within the screening window of 10 days after hospital admission for the index ACS event. Participant should have received acute phase treatment for the index ACS, such as intravenous anticoagulant or antiplatelet, and are receiving maintenance dual antiplatelet therapy (DAPT) with either clopidogrel plus acetyl salicylic acid (ASA), or ticagrelor plus ASA, with the intent to continue the treatment with a platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor) after randomization
  • Participants must agree to provide a pharmacogenomics deoxyribonucleic acid (DNA) sample

Who cannot join

  • Participant has any conditions that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk
  • Participant with a prior stroke of any etiology or transient ischemic attack (TIA)
  • Participant who received thrombolytic therapy as treatment for the index ACS event cannot be enrolled in the ticagrelor stratum
  • Participant has anticipated need for chronic administration of omeprazole or esomeprazole concomitantly with clopidogrel
  • Participant has known allergy or intolerance to ASA or rivaroxaban

Trial locations and contacts

259 sites in 20 countries.

259 sites in 20 countries

United States49 sites

  • Study site

    Abington, Pennsylvania

  • Study site

    Alexander City, Alabama

  • Study site

    Amarillo, Texas

  • Study site

    Athens, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Banning, California

  • Study site

    Bartlesville, Oklahoma

  • Study site

    Bay City, Michigan

  • Study site

    Boise, Idaho

  • Study site

    Cincinnati, Ohio

  • Study site

    Coeur d'Alene, Idaho

  • Study site

    Columbia, Missouri

  • Study site

    Cumming, Georgia

  • Study site

    Danville, Virginia

  • Study site

    Fort Sam Houston, Texas

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jerseyville, Illinois

  • Study site

    Jupiter, Florida

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kalispell, Montana

  • Study site

    Langhorne, Pennsylvania

  • Study site

    Lansing, Michigan

  • Study site

    Littleton, Colorado

  • Study site

    Macon, Georgia

  • Study site

    Miami, Florida

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mount Clemens, Michigan

  • Study site

    Munster, Indiana

  • Study site

    Oak Ridge, Tennessee

  • Study site

    Odessa, Texas

  • Study site

    Orlando, Florida

  • Study site

    Pensacola, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Puyallup, Washington

  • Study site

    Rapid City, South Dakota

  • Study site

    Rocky Mount, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    Sanford, North Carolina

  • Study site

    Sayre, Pennsylvania

  • Study site

    St Louis, Missouri

  • Study site

    Stony Brook, New York

  • Study site

    Sylmar, California

  • Study site

    Tampa, Florida

  • Study site

    Tucker, Georgia

  • Study site

    Tulsa, Oklahoma

  • Study site

    York, Pennsylvania

  • Study site

    Ypsilanti, Michigan

  • Study site

    Zanesville, Ohio

Other trials in United States

Poland20 sites

  • Study site

    Bielsko-Biala

  • Study site

    Bytom

  • Study site

    Chrzanów

  • Study site

    Dąbrowa Górnicza

  • Study site

    Gdynia

  • Study site

    Grodzisk Mazowiecki

  • Study site

    Inowrocław

  • Study site

    Kędzierzyn-Koźle

  • Study site

    Kielce

  • Study site

    Koszalin

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Nowy Targ

  • Study site

    Nysa

  • Study site

    Oświęcim

  • Study site

    Polanica-Zdrój

  • Study site

    Puławy

  • Study site

    Tychy

  • Study site

    Warsaw

  • Study site

    Włocławek

Other trials in Poland

Russia18 sites

  • Study site

    Barnaul

  • Study site

    Chita

  • Study site

    Ivanovo

  • Study site

    Kaliningrad

  • Study site

    Kemerovo

  • Study site

    Krasnodar

  • Study site

    Krasnoyarsk

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Orenburg

  • Study site

    Penza

  • Study site

    Perm

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Syktyvkar

  • Study site

    Tyumen

  • Study site

    Yekaterinburg

Other trials in Russia

Brazil15 sites

  • Study site

    Belo Horizonte

  • Study site

    Blumenau

  • Study site

    Campina Grande do Sul

  • Study site

    Campinas

  • Study site

    Curitiba

  • Study site

    Marília

  • Study site

    Passo Fundo

  • Study site

    Porto Alegre

  • Study site

    Recife

  • Study site

    Salvador

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

  • Study site

    Tatuí

  • Study site

    Uberlândia

  • Study site

    Votuporanga

Other trials in Brazil

Japan14 sites

  • Study site

    Gifu

  • Study site

    Kagawa

  • Study site

    Kitakyushu

  • Study site

    Kobe

  • Study site

    Kumamoto

  • Study site

    Matsue

  • Study site

    Nagano

  • Study site

    Osaka

  • Study site

    Sayama-Shi

  • Study site

    Tokyo

  • Study site

    Uwajima-Shi

  • Study site

    Yokohama

  • Study site

    Yonago

  • Study site

    Yotsui 2-8-1

Other trials in Japan

Argentina13 sites

  • Study site

    Buenos Aires

  • Study site

    Caba

  • Study site

    Ciudad de Buenos Aires

  • Study site

    Córdoba

  • Study site

    Cordooba

  • Study site

    Corrientes

  • Study site

    La Plata

  • Study site

    Mar del Plata

  • Study site

    Resistencia

  • Study site

    Rosario

  • Study site

    Salta

  • Study site

    San Martin

  • Study site

    Santa Fe

Other trials in Argentina

Belgium13 sites

  • Study site

    Antwerp

  • Study site

    Bonheiden

  • Study site

    Brasschaat

  • Study site

    Bruges

  • Study site

    Edegem

  • Study site

    Genk

  • Study site

    Ghent

  • Study site

    Huy

  • Study site

    Liège

  • Study site

    Mol

  • Study site

    Roeselare

  • Study site

    Ronse

  • Study site

    Turnhout

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Netherlands13 sites

  • Study site

    's-Hertogenbosch

  • Study site

    Amersfoort

  • Study site

    Amsterdam

  • Study site

    Blaricum

  • Study site

    Den Helder

  • Study site

    Gouda

  • Study site

    Groningen

  • Study site

    Hoofddorp

  • Study site

    Hoogeveen

  • Study site

    Nijmegen

  • Study site

    Rotterdam

  • Study site

    Schiedam

  • Study site

    The Hague

Other trials in Netherlands

Australia11 sites

  • Study site

    Brisbane

  • Study site

    Cairns

  • Study site

    Chermside

  • Study site

    Elizabeth Vale

  • Study site

    Herston

  • Study site

    Hobart

  • Study site

    Launceston

  • Study site

    Liverpool

  • Study site

    Murdoch

  • Study site

    Nambour

  • Study site

    New Lambton Heights

Other trials in Australia

Canada11 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Greater Sudbury, Ontario

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    New West Minister, British Columbia

  • Study site

    Newmarket, Ontario

  • Study site

    Québec

  • Study site

    Saint-Charles-Borromée, Quebec

  • Study site

    Sherbrooke, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Victoria, British Columbia

Other trials in Canada

Turkey (Türkiye)11 sites

  • Study site

    Adana

  • Study site

    Ankara

  • Study site

    Aydin

  • Study site

    Bursa

  • Study site

    Diyarbakır

  • Study site

    Eskişehir

  • Study site

    Istanbul

  • Study site

    Kahramanmaraş

  • Study site

    Kocaeli

  • Study site

    Konya

  • Study site

    Sivas

Other trials in Turkey (Türkiye)

Bulgaria10 sites

  • Study site

    Blagoevgrad

  • Study site

    Burgas

  • Study site

    Haskovo

  • Study site

    Lovech

  • Study site

    Pazardzhik

  • Study site

    Pleven

  • Study site

    Rousse

  • Study site

    Sandanski

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

Hungary10 sites

  • Study site

    Balatonfüred

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Győr

  • Study site

    Gyula

  • Study site

    Kaposvár

  • Study site

    Kecskemét

  • Study site

    Nyíregyháza

  • Study site

    Székesfehérvár

  • Study site

    Szolnok

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Ukraine10 sites

  • Study site

    Cherkasy

  • Study site

    Dnipropetrovsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Lutsk

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Ternopil

  • Study site

    Zaporizhzhya

  • Study site

    Zhytomyr

Other trials in Ukraine

Spain9 sites

  • Study site

    A Coruña

  • Study site

    Almería

  • Study site

    Ávila

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Murcia

  • Study site

    Sant Boi de Llobregat

  • Study site

    Tarragona

Other trials in Spain

Sweden9 sites

  • Study site

    Falun

  • Study site

    Jönköping

  • Study site

    Linköping

  • Study site

    Lund

  • Study site

    Örebro

  • Study site

    Östersund

  • Study site

    Stockholm

  • Study site

    Sundsvall

  • Study site

    Uppsala

Other trials in Sweden

France8 sites

  • Study site

    Besançon

  • Study site

    Chambray-lès-Tours

  • Study site

    Jossigny

  • Study site

    Le Coudray

  • Study site

    Lyon

  • Study site

    Montauban

  • Study site

    Nantes

  • Study site

    Périgueux

Other trials in France

Czechia7 sites

  • Study site

    Brno

  • Study site

    Kolin Iii.

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    Ostrava

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    Plzen-Bory

  • Study site

    Prague

  • Study site

    Třebíč

  • Study site

    Znojmo

Other trials in Czechia

South Korea5 sites

  • Study site

    Gwangju

  • Study site

    Incheon

  • Study site

    Seongnam

  • Study site

    Seoul

  • Study site

    Suwon

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Denmark3 sites

  • Study site

    Herlev

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    Køge

  • Study site

    Silkeborg

Other trials in Denmark

About this study

Official title: A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrome

The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome [NSTE-ACS]).

Read the detailed description

This is a prospective, randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel group (each group of participants will be treated at the same time), multicenter (when more than one hospital or medical school team work on a medical research study) study in participants with a recent ACS (STEMI or NSTE-ACS). All the eligible participants receiving background treatment of ASA plus clopidogrel (Stratum 1) or ASA plus ticagrelor (Stratum 2) will be randomly assigned to either receive ASA or rivaroxaban on background of P2Y12 receptor antagonists treatment. This study will include 3 phases: Screening Phase (up to 10 days, before study start on Day 1), Double-blind Treatment Phase (up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier), and Follow-up Phase (up to 30 days). Participants' safety will be monitored throughout the study.

Being tested
Acetylsalicylic acid, Rivaroxaban, Clopidogrel, Ticagrelor
Keywords
Acute Coronary Syndrome, Myocardial infarction, Unstable angina, Acetylsalicylic acid, Rivaroxaban, JNJ-39039039, Bay 59-7939, Xarelto, Clopidogrel, Ticagrelor, Plavix, Brilinta, Effient
Medical subject headings
Acute Coronary Syndrome, Myocardial Infarction, Angina, Unstable

What participants receive

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

  • Acetylsalicylic acidDrug

    Also called Aspirin

    ASA 100 mg enteric-coated tablet once daily orally.

  • RivaroxabanDrug

    Also called JNJ-39039039, Bay 59-7939, Xarelto

    Rivaroxaban 2.5 mg tablet twice daily orally.

  • ClopidogrelDrug

    Also called Plavix

    Clopidogrel 75 mg once daily orally.

  • TicagrelorDrug

    Also called Brilinta

    Ticagrelor 90 mg twice daily orally.

Study groups in NCT02293395
Study groupRoleWhat they receive
Stratum 1/ASAActive comparatorAcetylsalicylic acid (ASA) 100 milligram (mg) enteric-coated tablet once daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Receives: Drug: Acetylsalicylic acid; Drug: Clopidogrel
Stratum 1/RivaroxabanExperimentalRivaroxaban 2.5 mg tablet twice daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Receives: Drug: Rivaroxaban; Drug: Clopidogrel
Stratum 2/ASAActive comparatorASA 100 mg enteric-coated tablet once daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Receives: Drug: Acetylsalicylic acid; Drug: Ticagrelor
Stratum 2/RivaroxabanExperimentalRivaroxaban 2.5 mg tablet twice daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Receives: Drug: Rivaroxaban; Drug: Ticagrelor

What is being measured

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

  1. Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events

    Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of >=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - <5 g/dl (or drop in hematocrit of 9 - <15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.

    Measured: From start of study treatment until follow-up (up to 390 days)

Timeline

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

  1. First posted18 Nov 2014 (estimated)
  2. Study start20 Apr 2015
  3. Primary completion14 Oct 2016
  4. Study completion14 Oct 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,037 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02293395
Sponsor's protocol ID
CR106261
Other IDs
RIVAROXACS2002, 2014-004266-26, 2014
Acronym
GEMINI ACS 1
Status last verified
Nov 2017
First submitted
13 Nov 2014
Last updated
26 Dec 2017
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • 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

  • Povsic TJ, Ohman EM, Roe MT, White J, Rockhold FW, Montalescot G, Cornel JH, Nicolau JC, Steg PG, James S, Bode C, Welsh RC, Plotnikov AN, Mundl H, Gibson CM. P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes. JAMA Cardiol. 2019 Jul 1;4(7):680-684. doi: 10.1001/jamacardio.2019.1510.

    PubMed 31141104

  • Ohman EM, Roe MT, Steg PG, James SK, Povsic TJ, White J, Rockhold F, Plotnikov A, Mundl H, Strony J, Sun X, Husted S, Tendera M, Montalescot G, Bahit MC, Ardissino D, Bueno H, Claeys MJ, Nicolau JC, Cornel JH, Goto S, Kiss RG, Guray U, Park DW, Bode C, Welsh RC, Gibson CM. Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial. Lancet. 2017 May 6;389(10081):1799-1808. doi: 10.1016/S0140-6736(17)30751-1. Epub 2017 Mar 18.

    PubMed 28325638

  • Povsic TJ, Roe MT, Ohman EM, Steg PG, James S, Plotnikov A, Mundl H, Welsh R, Bode C, Gibson CM. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study. Am Heart J. 2016 Apr;174:120-8. doi: 10.1016/j.ahj.2016.01.004. Epub 2016 Jan 18.

    PubMed 26995378

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acetylsalicylic acid, Rivaroxaban and Clopidogrel in people with Acute Coronary Syndrome, run by Janssen Research & Development, LLC at 259 sites in 20 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 5 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 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 259 sites in United States, Poland, Russia, Brazil, Japan and 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Nov 2017). 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?

Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (time frame: From start of study treatment until follow-up (up to 390 days)). 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 NCT02293395, which also lists 4 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 26 Dec 2017.

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