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: February 24, 2014
Last verified: February 2014

December 16, 2008
February 24, 2014
November 2008
September 2011   (final data collection date for primary outcome measure)
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 primary outcome measure is the reduction in the risk of the composite endpoint of CV death, MI, or stroke.
Complete list of historical versions of study NCT00809965 on ClinicalTrials.gov Archive Site
  • 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 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 ]
    TIMI (thrombolysis in myocardial infarction) bleeding criteria are used to classify major and minor bleeding events in myocardial infarction patients treated with drugs to dissolve clots.
  • 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 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 ]
Secondary outcome include assessments of the composite of all cause of death, MI, or stroke, assessments of the composite primary endpoint including severe recurent ischemia and the net clinical outcome (the composite of efficacy and safety endpoints).
Not Provided
Not Provided
 
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Myocardial Ischemia
  • Unstable Angina
  • Drug: Rivaroxaban 2.5 mg
    One tablet twice daily
  • Drug: Rivaroxaban 5 mg
    One tablet twice daily
  • Drug: Placebo
    One placebo tablet twice daily
  • Drug: Standard of care
  • Experimental: Rivaroxaban 2.5 mg bid
    One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
    Interventions:
    • Drug: Rivaroxaban 2.5 mg
    • Drug: Standard of care
  • Experimental: Rivaroxaban 5 mg bid
    One 5 mg rivaroxaban tablet twice daily for up to 6 months
    Interventions:
    • Drug: Rivaroxaban 5 mg
    • Drug: Standard of care
  • Placebo Comparator: Placebo
    One placebo tablet twice daily for up to 6 months
    Interventions:
    • Drug: Placebo
    • Drug: Standard of care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15526
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czech Republic,   Denmark,   Egypt,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Morocco,   Netherlands,   New Zealand,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Sweden,   Thailand,   Tunisia,   Turkey,   Ukraine,   United Kingdom
 
NCT00809965
CR014710, RIVAROXACS3001
Yes
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bayer
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP