BLeeding Events and Maintenance DoSe of PraSugrel

Study Overview
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Brief Summary
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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).

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

Conditions
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Adverse Reaction to Antiplatelet Agent, Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Prasugrel dose 5 mg/day
* Drug: Prasugrel dose 10 mg/day


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prasugrel dose 5 mg/day<br>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 | Drug: Prasugrel dose 5 mg/day<br> <br> |
| Active Comparator: Prasugrel dose 10 mg/day<br>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 | Drug: Prasugrel dose 10 mg/day<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding | major, minor and minimal bleeding defined according BARC (Bleeding Academic Research Consortium criteria (11), occurring from 1 month to the end of the study. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | MACE (cardiac death, Myocardial Infarction, stroke) occurring from 1 month to the end of the study; late stent thrombosis. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prasugrel, antiplatelet, Acute Coronary Syndrome