A study to assess the safety and efficacy of Fondaparinux in unstable angina and non-ST elevation myocardial infarction compared to historical controls treated with Enoxaparin.
Phase 3
- Registration Number
- CTRI/2008/091/000309
- Lead Sponsor
- Christian Medical College, Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Patients will be eligible if they meet at least 1 of the 3 following criteria:
1. Unstable angina as defined as angina pectoris or equivalent type of ischemic discomfort with at least one of 3 features:
a) Occurring at rest or with minimal exertion and usually lasting more than 20 min.
b) Being severe and frank pain and of new onset
c) Occurring with a crescendo pattern
2. An elevated level of troponin or creatine kinase MB
3. ECG changes indicative of ischemia.
Exclusion Criteria
1. Contraindications to anticoagulation
2. Recent hemorrhagic stroke
3. Indications for anticoagulation other than an acute coronary syndrome
4. Serum creatinine level >3 mg/dl.
5. Severe hepatic failure
6. Any active major bleeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy outcome: A composite outcome measure comprising of Death/ nonfatal myocardial infarction/ refractory angina <br>Primary safety outcome: major/minor bleeding or stroke <br>Timepoint: At 1 month
- Secondary Outcome Measures
Name Time Method Death, nonfatal myocardial infarction, refractory angina, stroke or major or minor bleeding at 1 week and rate of revascularization within 1week and within 1 month.Timepoint: 1 week and 1 month