None listed
Conditions
Interventions
Intervention1: Fondaparinux: 2.5mg once daily subcutaneously for a minimum duration of 5 days.
Control Intervention1: Enoxaparin: Historical controls given enoxaparin
1mg/kg twice daily
Sponsors
Christian Medical College, Vellore
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome: A composite outcome measure comprising of Death/ nonfatal myocardial infarction/ refractory angina Primary safety outcome: major/minor bleeding or stroke Timepoint: At 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactLeena Thomas
Outcome results
None listed