Trial | NCT01790854  Report issue

Title

BLeeding Events and Maintenance DoSe of PraSugrel
Bless Study (BLeeding Events and Maintenance DoSe of PraSugrel)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    prasugrel ...

  • Study Participants

    195
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).
Study Started
Nov 30
2012
Primary Completion
Oct 31
2014
Study Completion
Oct 31
2014
Last Update
Jul 29
2016
Estimate

Drug Prasugrel dose 5 mg/day

Drug Prasugrel dose 10 mg/day

Prasugrel dose 5 mg/day Experimental

225 patients will be treated with 325 mg of aspirin (followed by a maintenance dosage of 100 mg of aspirin for at least 1 year and with 60 mg loading dose of prasugrel followed by a maintenance dosage of 5 mg/day of prasugrel for 12 months

Prasugrel dose 10 mg/day Active Comparator

225 patients will be treated with 325 mg of aspirin (followed by a maintenance dosage of 100 mg of aspirin for at least 1 year and with 60 mg loading dose of prasugrel followed by a maintenance dosage of 10 mg/day of prasugrel for 12 months

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
No Results Posted