An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
- Conditions
- Acute Coronary Syndrome Myocardial Infarction Myocardial Ischemia Unstable Angina
- Registration Number
- CTRI/2011/08/001941
- 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.
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.
India: 1550 patients screened, 1469 patients randomized, FPI: 10-Mar-2009, First subject randomized: 17-Mar-2009, Last Patient Enroled : 24-Dec-2010, Last Patient Last Visit : 09-Sep-2011
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15527
- Inclusion Criteria: Ages Eligible for Study: 18 Years and older.
- There is no upper age limit for this study.
- Genders Eligible for Study: Both 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: Patient below 18 years of age.
- 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint is the composite of CV death, MI, or stroke. 6-day screening phase,- treatment phase (consisting of double-blind treatment and follow-up) extending from Day 1 (baseline). - enrollment period estimated to last 27 months, the double-blind treatment phase will last for an additional 6 months, and the follow-up period will last 30 days, making the total study duration approximately 34 months. Study will end when at least 983 primary efficacy endpoints accrue across both strata, and at least 728 primary efficacy endpoints in Stratum 2
- Secondary Outcome Measures
Name Time Method The composite of all cause death, MI, or stroke. - Net clinical outcome, defined as the composite of CV death, MI, ischemic stroke, or TIMI major bleeding event not associated with CABG surgery - Assessments of the composite of CV death, MI, stroke, or severe recurrent ischemia requiring revascularization. - Assessments of the composite of CV death, MI, stroke, or severe recurrent ischemia leading to hospitalization. 6-day screening phase,- treatment phase (consisting of double-blind treatment and follow-up) extending from Day 1 (baseline). - enrollment period estimated to last 27 months, the double-blind treatment phase will last for an additional 6 months, and the follow-up period will last 30 days, making the total study duration approximately 34 months. Study will end when at least 983 primary efficacy endpoints accrue across both strata, and at least 728 primary efficacy endpoints in Stratum 2- FPI: 28-Nov-2008, - LPI: 30-Jan-2011, - LPO: 27-Jun-2011
Trial Locations
- Locations (54)
A J Hospital & Research Centre
🇮🇳Trauma,, AJHRC, India
AMRI Hospital
🇮🇳Kolkata, WEST BENGAL, India
Apollo Gleneagles Hospital
🇮🇳Kolkata, WEST BENGAL, India
Apollo Hospital
🇮🇳Chennai, TAMIL NADU, India
Apollo Hospitals
🇮🇳Hyderabad, ANDHRA PRADESH, India
Apollo Hospitals International Ltd.
🇮🇳Ahmadabad, GUJARAT, India
Bankers Heart Institute
🇮🇳Vadodara, GUJARAT, India
Baroda Heart Institute & Research Centre
🇮🇳Vadodara, GUJARAT, India
Bisne Heart Clinic & Hospital
🇮🇳Nagpur, MAHARASHTRA, India
CIMS Hospital
🇮🇳Ahmadabad, GUJARAT, India
Scroll for more (44 remaining)A J Hospital & Research Centre🇮🇳Trauma,, AJHRC, IndiaDr. PurushothamPrincipal investigator08242225533drrpurushotham@yahoo.com