BLeeding Events and Maintenance DoSe of PraSugrel

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Antoniucci
• Collaborator: A.R. CARD Onlus Foundation
• Treatments: Prasugrel Hydrochloride

Criteria

Inclusion Criteria:

• all ACS patients treated with PCI (percutaneous coronary intervention) and dual antiplatelet therapy (DAPT: aspirin plus prasugrel).

• Informed written consent

Exclusion Criteria:

• Age < 18 years

• Active bleeding; bleeding diathesis; coagulopathy

• History of gastrointestinal or genitourinary bleeding <2 months

• Major surgery in the last 6 weeks

• History of intracranial bleeding or structural abnormalities

• Suspected aortic dissection

• Any previous TIA (transient ischemic attack)/stroke

• Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux .

• Known relevant hematological deviations: Hb <10 g/dl, Thrombocytopenia. <100x10^9/l

• Use of coumadin derivatives within the last 7 days

• Chronic therapy with prasugrel or ticagrelor

• Known malignancies or other comorbid conditions with life expectancy <1 year

• Known severe liver disease, severe renal failure

• Known allergy to the study medications

• Pregnancy