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BLeeding Events and Maintenance DoSe of PraSugrel

NCT01790854 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2016-07-29

No results posted yet for this study

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).

Conditions

  • Adverse Reaction to Antiplatelet Agent
  • Acute Coronary Syndrome

Interventions

DRUG

Prasugrel dose 5 mg/day

DRUG

Prasugrel dose 10 mg/day

Sponsors & Collaborators

  • A.R. CARD Onlus Foundation

    collaborator OTHER

  • David Antoniucci

    lead OTHER

Principal Investigators

  • David Antoniucci, MD · Careggi Hospital, division of Invasive Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01790854 on ClinicalTrials.gov