drugset / Trial / NCT01790854
BLeeding Events and Maintenance DoSe of PraSugrel
RandomizedParallel-groupOpen-labelTreatment
Summary
Aim: to verify if after the acute phase of ACS acute coronary syndrome (1-months), from 1 to 12 months the reduction of maintenance dose of prasugrel from 10 mg to 5 mg/day may reduce the bleeding events (5 mg vs 10 mg). All patients will be treated with 325 mg of aspirin followed by a maintenance dosage of 100 mg of aspirin for at least 1 year. At baseline (after 60 mg loading dose of prasugrel) and after 1 month (7 days after the randomization at 10 or 5 mg of prasugrel) all patients will undergo light transmittance aggregometry (LTA) test to evaluate residual platelet reactivity (pharmacodynamic effects).
Timeline
- Start
- 2012-11
- Primary completion
- 2014-10
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prasugrel | Small molecule | 5 mg | — |
| Subject | Prasugrel | Small molecule | 10 mg | — |