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Trial record 39 of 509 for:    ASPIRIN AND P2

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
Recruitment Status : Completed
First Posted : November 18, 2014
Results First Posted : November 13, 2017
Last Update Posted : December 26, 2017
Sponsor:
Collaborators:
Bayer
Duke Clinical Research Institute
Harvard Medical School
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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

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.

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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
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 Name: Aspirin

Drug: Clopidogrel
Clopidogrel 75 mg once daily orally.
Other Name: 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: Rivaroxaban
Rivaroxaban 2.5 mg tablet twice daily orally.
Other Names:
  • JNJ-39039039
  • Bay 59-7939
  • Xarelto

Drug: Clopidogrel
Clopidogrel 75 mg once daily orally.
Other Name: Plavix

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 Name: Aspirin

Drug: Ticagrelor
Ticagrelor 90 mg twice daily orally.
Other Name: 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:
  • JNJ-39039039
  • Bay 59-7939
  • Xarelto

Drug: Ticagrelor
Ticagrelor 90 mg twice daily orally.
Other Name: Brilinta




Primary Outcome Measures :
  1. 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


  Show 262 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Bayer
Duke Clinical Research Institute
Harvard Medical School
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02293395     History of Changes
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

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Acetylsalicylic acid
Acute Coronary Syndrome
Myocardial infarction
Unstable angina
Rivaroxaban
JNJ-39039039
Bay 59-7939
Xarelto
Clopidogrel
Ticagrelor
Plavix
Brilinta
Effient
Additional relevant MeSH terms:
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Aspirin
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Rivaroxaban
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents