Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping ™ Assay

Phase 4

• Conditions: 30 Healthy People
• Interventions: Drug: Clopidogrel and proton pump inhibitors

• Registration Number: NCT01023360
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Currently, drugs commonly used for antiplatelet are aspirin and clopidogrel when encountering stroke or coronary heart disease. In this study, we would use VASP assay and thromboelastograph with platelet mapping assay kit to evaluate the antiplatelet resistance in general population and the relationship between clopidogrel and proton pump inhibitor.

Detailed Description

This study intent is to search the standard to diagnose of the antiplatelet drug resistance and to discover the prevalence of drug resistance in Taiwanese population in Taiwan. The trial will enroll at least 30 healthy people after fulfilling the investigation questionnaire. All the participants will receive antiplatelet drugs in two separate period and measured the efficacy by VASP assay and thromboelastograph with platelet mapping assay. The health volunteer will receive clopidogrel and different types of proton pump inhibitor to see the interference of antiplatelet efficacy between each drug.

Study Timeline

• Study Start: 2008-05
• Status Verified: 2008-06
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2009-12-01
• Last Update Submitted: 2009-12-01
• Study First Posted: 2009-12-02
• Last Update Posted: 2009-12-02
• Primary Completion: 2010-10
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 30 Healthy people, without major systemic disease, not under medication treatment

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Exclusion Criteria

• Systemic disease, under medication control with NSAID, anticoagulants, taking antiplatelet drugs before entering trial, Chinese herb, pregnant or breast feeding woman

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clopidogrel and proton pump inhibitors	Clopidogrel and proton pump inhibitors	all participating healthy people should receive clopidogrel and 3 kinds of PPI sequentially with one week interval between each PPI.

Primary Outcome Measures

Name	Time	Method
Comparison of the antiplatelet drug response apparently shown in TEG & Platelet mapping assay	6 months

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan