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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00809965
First Posted: December 17, 2008
Last Update Posted: September 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 15526
Study Start Date: November 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


  Show 584 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bayer
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

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

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00809965     History of Changes
Other Study ID Numbers: CR014710
RIVAROXACS3001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
First Submitted: December 16, 2008
First Posted: December 17, 2008
Results First Submitted: May 5, 2014
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:
Syndrome
Infarction
Myocardial Infarction
Ischemia
Acute Coronary Syndrome
Myocardial Ischemia
Coronary Artery Disease
Angina, Unstable
Disease
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action