30 Healthy People
Conditions
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.
Interventions
DRUGClopidogrel 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
Sponsors
Haemonetics Corporation
National Taiwan University Hospital
Study design
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the antiplatelet drug response apparently shown in TEG & Platelet mapping assay | 6 months |
Countries
Taiwan
Contacts
Primary ContactFu-Tien Chiang, MD, PhD
Backup ContactJen-Kuang Lee, MD
Outcome results
None listed