BLeeding Events and Maintenance DoSe of PraSugrel

Phase 4

Terminated

• Conditions: Acute Coronary Syndrome; Adverse Reaction to Antiplatelet Agent
• Interventions: Drug: Prasugrel dose 5 mg/day; Drug: Prasugrel dose 10 mg/day

• Registration Number: NCT01790854
• Lead Sponsor: David Antoniucci

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 195

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prasugrel dose 5 mg/day	Prasugrel dose 5 mg/day	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	Prasugrel dose 10 mg/day	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

Primary Outcome Measures

Name	Time	Method
bleeding	12 months	major, minor and minimal bleeding defined according BARC (Bleeding Academic Research Consortium criteria (11), occurring from 1 month to the end of the study.

Secondary Outcome Measures

Name	Time	Method
MACE	12 months	MACE (cardiac death, Myocardial Infarction, stroke) occurring from 1 month to the end of the study; late stent thrombosis.

Trial Locations

Locations (1)

Careggi Hospital; 🇮🇹 Florence, Italy