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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00809965
First received: December 16, 2008
Last updated: May 5, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809965

  Show 583 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

No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional 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
Study First Received: December 16, 2008
Results First Received: May 5, 2014
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration
Croatia: Ministry of Health and Social Care
Great Britain: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Ukraine: State Pharmacological Center - Ministry of Health

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:
Angina, Unstable
Myocardial Ischemia
Coronary Artery Disease
Infarction
Ischemia
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Necrosis
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014