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Prasugrel Versus Clopidogrel to TREAT High Platelet Reactivity

NCT01493999 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2014-10-08

No results posted yet for this study

Summary

MAIN AIM: To compare the pharmacological potency of administering adjusted 600 mg clopidogrel loading doses and 60 mg prasugrel in patients with high on-clopidogrel platelet reactivity (HPR) after PCI.

SECONDARY OBJECTIVES: To define the optimal maintenance dose with both prasugrel (5 mg vs. 10 mg) and clopidogrel (75 mg vs. 150 mg) in patients with HPR for chronic therapy.

DESIGN: Prospective, Randomized, Open-label, Single-center trial.

PRIMARY ENDPOINT: Platelet reactivity measured with Multiplate between clopidogrel and prasugrel arm at day 4.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Clopidogrel reloading

Up to three times 600 mg clopidogrel

DRUG

Prasugrel

60 mg prasugrel in patients with HPR

Sponsors & Collaborators

  • University of Pecs

    lead OTHER

Principal Investigators

  • Dániel Aradi, MD PhD · University of Pécs, Heart Institute, Hungary

  • András Komócsi, MD PhD · University of Pécs, Heart Institute, Hungary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-01-31
Completion
2013-04-30

Countries

  • Hungary

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 NCT01493999 on ClinicalTrials.gov