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

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ClinicalTrials.gov Identifier: NCT00809965
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : June 2, 2014
Last Update Posted : September 17, 2014
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Myocardial Infarction Myocardial Ischemia Unstable Angina Drug: Rivaroxaban 2.5 mg Drug: Rivaroxaban 5 mg Drug: Placebo Drug: Standard of care Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Rivaroxaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rivaroxaban 2.5 mg bid
One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
 Drug: Rivaroxaban 2.5 mg
One tablet twice daily

Drug: Standard of care
Experimental: Rivaroxaban 5 mg bid
One 5 mg rivaroxaban tablet twice daily for up to 6 months
 Drug: Rivaroxaban 5 mg
One tablet twice daily

Drug: Standard of care
Placebo Comparator: Placebo
One placebo tablet twice daily for up to 6 months
 Drug: Placebo
One placebo tablet twice daily

Drug: Standard of care


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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.


Secondary Outcome Measures :
  1. The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke [ Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) ]
    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.

  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 [ Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) ]
    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.

  3. The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization [ Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) ]
    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.

  4. The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization [ Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) ]
    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.


Eligibility Criteria
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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:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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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): NCT00809965


Locations
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Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bayer
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00809965    
Other Study ID Numbers: CR014710
RIVAROXACS3001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
First Posted: December 17, 2008    Key Record Dates
Results First Posted: June 2, 2014
Last Update Posted: September 17, 2014
Last Verified: August 2014
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Rivaroxaban
Acute Coronary Syndrome
ACS
Aspirin
Thienopyridine
 Unstable Angina
Myocardial Infarction
Anticoagulation
Clopidogrel (Plavix)
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Myocardial Ischemia
Angina, Unstable
Syndrome
Infarction
Ischemia
Disease
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants