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Tailored Antiplatelet Therapy Versus Recommended Dose of Prasugrel

NCT01538446 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2017-01-11

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the superiority of a strategy of platelet monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders and up-adjustment of the dose of prasugrel in low responders as compared to a more conventional strategy of a fixed dose of 5 mg to every patient without monitoring (Conventional Arm) as measured by a reduction in the composite endpoint of, cardiovascular (CV) death, myocardial infarction (MI) , stroke, stent thrombosis (ARC definition type "definite"), urgent revascularisation or bleeding (BARC definition type 2, 3 or 5).

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Modification of Prasugrel based on a biological assay

Monitoring with VerifyNow P2Y12, 2 weeks after initiation of 5 mg of maintenance dose of prasugrel, reduction of antiplatelet therapy if there is high on-treatment platelet inhibition (HPI) or increase in dosing if there is high on-treatment platelet reactivity (HPR) Device: VerifyNow point of care assay VerifyNow (ACCUMETRICS San Diego USA)

DRUG

prasugrel / clopidogrel

fixed dose of prasugrel 5 mg

DEVICE

Verify Now

Monitoring with VerifyNow P2Y12, 2 weeks after initiation of 5 mg of maintenance dose of prasugrel, reduction of antiplatelet therapy if there is high on-treatment platelet inhibition (HPI) or increase in dosing if there is high on-treatment platelet reactivity (HPR) Device: VerifyNow point of care assay VerifyNow (ACCUMETRICS San Diego USA)

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Daiichi Sankyo

    collaborator INDUSTRY

  • Allies in Cardiovascular Trials Initiatives and Organized

    collaborator OTHER

  • Accumetrics, Inc.

    collaborator INDUSTRY

  • Stentys

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Gilles MONTALESCOT, MD,PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

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 NCT01538446 on ClinicalTrials.gov