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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00809965
Other study ID # CR014710
Secondary ID RIVAROXACS3001
Status Completed
Phase Phase 3
First received December 16, 2008
Last updated August 26, 2014
Start date November 2008
Est. completion date September 2011

Study information

Verified date August 2014
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCroatia: Ministry of Health and Social CareGreat Britain: Medicines and Healthcare Products Regulatory AgencyHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesUkraine: State Pharmacological Center - Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15526
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Rivaroxaban 2.5 mg
One tablet twice daily
Rivaroxaban 5 mg
One tablet twice daily
Placebo
One placebo tablet twice daily
Standard of care


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Bayer

Countries where clinical trial is conducted

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke 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. From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) No
Secondary The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke 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. From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) No
Secondary 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 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. From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) No
Secondary The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization 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. From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) No
Secondary The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization 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. From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) No
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