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Platelet Reactivity in Stent Thrombosis Patients

NCT01012544 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2011-08-23

No results posted yet for this study

Summary

Recent studies have demonstrated a marked interindividual variability of clopidogrel's capacity to inhibit platelet aggregation with a substantial proportion (11-34%) of the patients considered non-responders to clopidogrel treatment. Variable intestinal absorption is suggested to contribute to the inconsistencies in response to clopidogrel. However, little is known about intestinal absorption in subjects who had suffered from a stent thrombosis. The MAPCAT-study has been designed to investigate whether plasma pharmacokinetics (represented by Cmax, Tmax and the AUC) after a 600 mg loading dose are significantly different between subjects who have suffered a stent thrombosis and subjects who have not suffered a stent thrombosis.

Conditions

  • Coronary Artery Stent Thrombosis

Interventions

DRUG

Clopidogrel

both arms of the study (patients with a history of stent thrombosis as well as patients who did not suffer from a stent thrombosis) will be given a 600 mg loading dose of clopidogrel

Sponsors & Collaborators

  • University of Cologne

    collaborator OTHER

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • J.M. ten Berg, MD, PhD · St Antonius center for platelet function research

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Netherlands

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 NCT01012544 on ClinicalTrials.gov