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 (GEMINI ACS 1)

November 30, 2017 updated by: Janssen Research & Development, LLC

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]).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3037

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Caba, Argentina
      • Ciudad De Buenos Aires, Argentina
      • Cordooba, Argentina
      • Corrientes, Argentina
      • Córdoba, Argentina
      • La Plata, Argentina
      • Mar Del Plata, Argentina
      • Resistencia, Argentina
      • Rosario, Argentina
      • Salta, Argentina
      • San Martín, Argentina
      • Santa Fe, Argentina
  • Australia
      • Brisbane, Australia
      • Cairns, Australia
      • Chermside, Australia
      • Elizabeth Vale, Australia
      • Herston, Australia
      • Hobart, Australia
      • Launceston, Australia
      • Liverpool, Australia
      • Murdoch, Australia
      • Nambour, Australia
      • New Lambton Heights, Australia
  • Belgium
      • Antwerpen, Belgium
      • Bonheiden, Belgium
      • Brasschaat, Belgium
      • Brugge, Belgium
      • Edegem, Belgium
      • Genk, Belgium
      • Gent, Belgium
      • Huy, Belgium
      • Liège, Belgium
      • Mol, Belgium
      • Roeselare, Belgium
      • Ronse, Belgium
      • Turnhout, Belgium
  • Brazil
      • Belo Horizonte, Brazil
      • Blumenau, Brazil
      • Campina Grande Do Sul, Brazil
      • Campinas, Brazil
      • Curitiba, Brazil
      • Marília, Brazil
      • Passo Fundo, Brazil
      • Porto Alegre, Brazil
      • Recife, Brazil
      • Salvador, Brazil
      • São José Do Rio Preto, Brazil
      • São Paulo, Brazil
      • Tatuí, Brazil
      • Uberlândia, Brazil
      • Votuporanga, Brazil
  • Bulgaria
      • Blagoevgrad, Bulgaria
      • Burgas, Bulgaria
      • Haskovo, Bulgaria
      • Lovech, Bulgaria
      • Pazardzhik, Bulgaria
      • Pleven, Bulgaria
      • Ruse, Bulgaria
      • Sandanski, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Canada
      • Québec, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • New West Minister, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Ontario
      • London, Ontario, Canada
      • Newmarket, Ontario, Canada
      • Sudbury, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Saint-Charles-Borromée, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • Czechia
      • Brno, Czechia
      • Kolin Iii., Czechia
      • Ostrava, Czechia
      • Plzen-Bory, Czechia
      • Praha 1, Czechia
      • Praha 2, Czechia
      • Trebic, Czechia
      • Znojmo, Czechia
  • Denmark
      • Herlev, Denmark
      • Koge, Denmark
      • Silkeborg, Denmark
  • France
      • Besançon, France
      • Chambray Les Tours, France
      • Jossigny, France
      • Le Coudray, France
      • Lyon, France
      • Montauban, France
      • Nantes, France
      • Nantes Cedex 1, France
      • Périgueux, France
  • Hungary
      • Balatonfüred, Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Gyula, Hungary
      • Győr, Hungary
      • Kaposvar, Hungary
      • Kecskemét, Hungary
      • Nyíregyháza, Hungary
      • Szolnok, Hungary
      • Székesfehérvár, Hungary
  • Japan
      • Gifu, Japan
      • Kagawa, Japan
      • Kitakyushu-City, Japan
      • Kobe-Shi, Japan
      • Kumamoto, Japan
      • Kumamoto-Shi, Japan
      • Matsue-Shi, Japan
      • Nagano-Shi, Japan
      • Osaka-Shi, Japan
      • Sayama-Shi, Japan
      • Tokyo, Japan
      • Uwajima-Shi, Japan
      • Yokohama, Japan
      • Yonago, Japan
      • Yotsui 2-8-1, Japan
  • Korea, Republic of
      • Gwangju, Korea, Republic of
      • Incheon, Korea, Republic of
      • Seongnam, Korea, Republic of
      • Seoul, Korea, Republic of
      • Suwon, Korea, Republic of
  • Netherlands
      • Amersfoort, Netherlands
      • Amsterdam, Netherlands
      • Blaricum, Netherlands
      • Den Haag, Netherlands
      • Den Helder, Netherlands
      • Gouda, Netherlands
      • Groningen, Netherlands
      • Hoofddorp, Netherlands
      • Hoogeveen, Netherlands
      • Nijmegen, Netherlands
      • Rotterdam, Netherlands
      • S-Hertogenbosch, Netherlands
      • Schiedam, Netherlands
  • Poland
      • Bielsko-Biala, Poland
      • Bytom, Poland
      • Chrzanow, Poland
      • Dabrowa Gornicza, Poland
      • Gdynia, Poland
      • Grodzisk Mazowiecki, Poland
      • Inowrocław, Poland
      • Kedzierzyn-Kozle, Poland
      • Kielce, Poland
      • Koszalin, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Nowy Targ, Poland
      • Nysa, Poland
      • Oswiecim, Poland
      • Polanica Zdroj, Poland
      • Pulawy, Poland
      • Tychy, Poland
      • Warszawa, Poland
      • Wloclawek, Poland
  • Russian Federation
      • Barnaul, Russian Federation
      • Chita, Russian Federation
      • Ekaterinburg, Russian Federation
      • Ivanovo, Russian Federation
      • Kaliningrad, Russian Federation
      • Kemerovo, Russian Federation
      • Krasnodar, Russian Federation
      • Krasnoyarsk, Russian Federation
      • Moscow, Russian Federation
      • Nizhniy Novgorod, Russian Federation
      • Orenburg, Russian Federation
      • Penza, Russian Federation
      • Perm, Russian Federation
      • Rostov On Don, Russian Federation
      • Saint Petersburg, Russian Federation
      • Samara, Russian Federation
      • Syktyvkar, Russian Federation
      • Tyumen, Russian Federation
  • Spain
      • A Coruña, Spain
      • Almería, Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Murcia, Spain
      • Málaga, Spain
      • Sant Boi De Llobregat, Spain
      • Tarragona, Spain
      • Ávila, Spain
  • Sweden
      • Falun, Sweden
      • Jönköping, Sweden
      • Linköping, Sweden
      • Lund, Sweden
      • Stockholm, Sweden
      • Sundsvall, Sweden
      • Uppsala, Sweden
      • Örebro, Sweden
      • Östersund, Sweden
  • Turkey
      • Adana, Turkey
      • Ankara, Turkey
      • Aydin, Turkey
      • Bursa, Turkey
      • Diyarbakir, Turkey
      • Eskisehir, Turkey
      • Istanbul, Turkey
      • Kahramanmaras, Turkey
      • Kocaeli, Turkey
      • Konya, Turkey
      • Sivas, Turkey
  • Ukraine
      • Cherkasy, Ukraine
      • Dnipropetrovsk, Ukraine
      • Kharkiv, Ukraine
      • Kyiv, Ukraine
      • Lutsk, Ukraine
      • Lviv, Ukraine
      • Odesa, Ukraine
      • Ternopil, Ukraine
      • Zaporizhzhia, Ukraine
      • Zhytomyr, Ukraine
  • United States
    • Alabama
      • Alexander City, Alabama, United States
    • California
      • Banning, California, United States
      • Sylmar, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Littleton, Colorado, United States
    • Florida
      • Jupiter, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Pensacola, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Athens, Georgia, United States
      • Cumming, Georgia, United States
      • Macon, Georgia, United States
      • Tucker, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
      • Coeur d'Alene, Idaho, United States
    • Illinois
      • Jerseyville, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
      • Munster, Indiana, United States
    • Michigan
      • Bay City, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Lansing, Michigan, United States
      • Mount Clemens, Michigan, United States
      • Ypsilanti, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • Columbia, Missouri, United States
      • Saint Louis, Missouri, United States
    • Montana
      • Kalispell, Montana, United States
    • New York
      • Stony Brook, New York, United States
    • North Carolina
      • Rocky Mount, North Carolina, United States
      • Sanford, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Zanesville, Ohio, United States
    • Oklahoma
      • Bartlesville, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Langhorne, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Sayre, Pennsylvania, United States
      • York, Pennsylvania, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Oak Ridge, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Fort Sam Houston, Texas, United States
      • Houston, Texas, United States
      • Odessa, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Danville, Virginia, United States
    • Washington
      • Puyallup, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stratum 1/ASA
Acetylsalicylic 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.
Drug: Acetylsalicylic acid
ASA 100 mg enteric-coated tablet once daily orally.
Other Names:
  • Aspirin
Drug: Clopidogrel
Clopidogrel 75 mg once daily orally.
Other Names:
  • Plavix
Experimental: Stratum 1/Rivaroxaban
Rivaroxaban 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.
Drug: Clopidogrel
Clopidogrel 75 mg once daily orally.
Other Names:
  • Plavix
Drug: Rivaroxaban
Rivaroxaban 2.5 mg tablet twice daily orally.
Other Names:
  • Xarelto
  • JNJ-39039039
  • Bay 59-7939
Active Comparator: Stratum 2/ASA
ASA 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.
Drug: Acetylsalicylic acid
ASA 100 mg enteric-coated tablet once daily orally.
Other Names:
  • Aspirin
Drug: Ticagrelor
Ticagrelor 90 mg twice daily orally.
Other Names:
  • Brilinta
Experimental: Stratum 2/Rivaroxaban
Rivaroxaban 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.
Drug: Rivaroxaban
Rivaroxaban 2.5 mg tablet twice daily orally.
Other Names:
  • Xarelto
  • JNJ-39039039
  • Bay 59-7939
Drug: Ticagrelor
Ticagrelor 90 mg twice daily orally.
Other Names:
  • Brilinta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
From start of study treatment until follow-up (up to 390 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Collaborators

Harvard Medical School (HMS and HSDM)
Bayer
Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2015

Primary Completion (Actual)

October 14, 2016

Study Completion (Actual)

October 14, 2016

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Actual)

December 26, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR106261
  • RIVAROXACS2002 (Other Identifier: Janssen Research & Development, LLC)
  • 2014-004266-26 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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