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Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

NCT01431495 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2011-09-09

No results posted yet for this study

Summary

This study aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in patients with coronary disease:

* Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600 mg loading dose or after the last maintenance dose (75 mg).
* Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events (MACE).
* Safety Criteria: severe bleeding (GUSTO scale).

Conditions

  • Coronary Disease

Interventions

DRUG

Pidogrel

Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.

DRUG

Plavix

Plavix(R) 75 mg/day for period ranging from 1 to 6 months.

Sponsors & Collaborators

  • Les Laboratoires des Médicaments Stériles

    lead INDUSTRY

Principal Investigators

  • Rachid MECHMECHE, MD · hospital La RABTA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • Tunisia

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 NCT01431495 on ClinicalTrials.gov