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)
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| ClinicalTrials.gov Identifier: NCT02293395 |
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Recruitment Status :
Completed
First Posted : November 18, 2014
Results First Posted : November 13, 2017
Last Update Posted : December 26, 2017
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Sponsor:
Janssen Research & Development, LLC
Collaborators:
Bayer
Duke Clinical Research Institute
Harvard Medical School (HMS and HSDM)
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Brief 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 syndrome (ACS: including ST segment elevation myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome [NSTE-ACS]).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Coronary Syndrome | Drug: Acetylsalicylic acid Drug: Rivaroxaban Drug: Clopidogrel Drug: Ticagrelor | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 3037 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 20, 2015 |
| Actual Primary Completion Date : | October 14, 2016 |
| Actual Study Completion Date : | October 14, 2016 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Acetylsalicylic acid
ASA 100 mg enteric-coated tablet once daily orally.
Other Name: Aspirin Drug: Clopidogrel Clopidogrel 75 mg once daily orally.
Other Name: Plavix |
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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.
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Drug: Rivaroxaban
Rivaroxaban 2.5 mg tablet twice daily orally.
Other Names:
Drug: Clopidogrel Clopidogrel 75 mg once daily orally.
Other Name: Plavix |
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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.
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Drug: Acetylsalicylic acid
ASA 100 mg enteric-coated tablet once daily orally.
Other Name: Aspirin Drug: Ticagrelor Ticagrelor 90 mg twice daily orally.
Other Name: Brilinta |
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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.
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Drug: Rivaroxaban
Rivaroxaban 2.5 mg tablet twice daily orally.
Other Names:
Drug: Ticagrelor Ticagrelor 90 mg twice daily orally.
Other Name: Brilinta |
Primary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293395
Locations
Show 262 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Bayer
Duke Clinical Research Institute
Harvard Medical School (HMS and HSDM)
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT02293395 |
| Other Study ID Numbers: |
CR106261 RIVAROXACS2002 ( Other Identifier: Janssen Research & Development, LLC ) 2014-004266-26 ( EudraCT Number ) |
| First Posted: | November 18, 2014 Key Record Dates |
| Results First Posted: | November 13, 2017 |
| Last Update Posted: | December 26, 2017 |
| Last Verified: | November 2017 |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Janssen Research & Development, LLC:
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Acute Coronary Syndrome Myocardial infarction Unstable angina Acetylsalicylic acid Rivaroxaban JNJ-39039039 Bay 59-7939 |
Xarelto Clopidogrel Ticagrelor Plavix Brilinta Effient |
Additional relevant MeSH terms:
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Acute Coronary Syndrome Syndrome Disease Pathologic Processes Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Aspirin Rivaroxaban Clopidogrel Ticagrelor Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists |