drugset / Trial / NCT01790854

BLeeding Events and Maintenance DoSe of PraSugrel

NCT01790854

Phase 4 Terminated 195 enrolled David Antoniucci A.R. CARD Onlus Foundation · collab
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

EvaluationDrugModalityDoseRoute
Subject Prasugrel Small molecule 5 mg
Subject Prasugrel Small molecule 10 mg