drugset / Trial / NCT01356992
Patients With High-risk Acute Coronary Syndrome Without ST-segment Elevation
RandomizedParallel-groupOpen-labelTreatment
Summary
This non-inferiority study aims at comparing Versa® to the reference enoxaparin (Clexane®, Sanofi-Aventis) in patients with high-risk unstable angina and NSTEMI. The main justification is the search for scientific evidence to prove the Versa® effectiveness for this new therapeutic indication, since it is a product with potential for reducing costs, with effectiveness and safety comparable to the reference drug.
Timeline
- Start
- 2012-07
- Primary completion
- 2013-07
- Completion
- 2013-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enoxaparin sodium | Other / unclassified | 1 mg/kg | Subcutaneous |