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

NCT ID: NCT01023360

Last Updated: 2009-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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30 Healthy People

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clopidogrel and proton pump inhibitors

Intervention Type DRUG

baseline detection --\> clopidogrel 75 mg PO QD for 1 week --\> clopidogrel 75 mg plus rabeprazole 20mg PO QD for 1 week --\> clopidogrel 75 mg PO QD for 1 week (wash-out phase) --\> clopidogrel 75 mg plus pantoprazole 40mg PO QD for 1 week --\> clopidogrel 75 mg PO QD for 1 week (wash-out phase) --\> clopidogrel 75 mg plus esomeprazole 40mg PO QD for 1 week --\>

1 week washout --\> aspirin 100mg PO QD for 1 week

Interventions

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Clopidogrel and proton pump inhibitors

baseline detection --\> clopidogrel 75 mg PO QD for 1 week --\> clopidogrel 75 mg plus rabeprazole 20mg PO QD for 1 week --\> clopidogrel 75 mg PO QD for 1 week (wash-out phase) --\> clopidogrel 75 mg plus pantoprazole 40mg PO QD for 1 week --\> clopidogrel 75 mg PO QD for 1 week (wash-out phase) --\> clopidogrel 75 mg plus esomeprazole 40mg PO QD for 1 week --\>

1 week washout --\> aspirin 100mg PO QD for 1 week

Intervention Type DRUG

Other Intervention Names

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clopidogrel rabeprazole pantoprazole esomeprazole

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Haemonetics Corporation

INDUSTRY

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

Principal Investigators

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Fu-Tien Chiang, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Fu-Tien Chiang, MD, PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Jen-Kuang Lee, MD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Fu-Tien Chiang, MD, PhD

Role: primary

Jen-Kuang Lee, MD

Role: backup

Other Identifiers

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200804034R

Identifier Type: -

Identifier Source: org_study_id