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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Haemonetics Corporation
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01023360
First received: August 7, 2008
Last updated: December 1, 2009
Last verified: June 2008

August 7, 2008
December 1, 2009
May 2008
October 2010   (final data collection date for primary outcome measure)
Comparison of the antiplatelet drug response apparently shown in TEG & Platelet mapping assay [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01023360 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping ™ Assay
Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping™ Assay

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.

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.

Interventional
Phase 4
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
30 Healthy People
Drug: 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

Other Names:
  • clopidogrel
  • rabeprazole
  • pantoprazole
  • esomeprazole
Experimental: 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.
Intervention: Drug: Clopidogrel and proton pump inhibitors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
Yes
Contact: Fu-Tien Chiang, MD, PhD 886-2-23123456 ext 62150 futienc@ntu.edu.tw
Contact: Jen-Kuang Lee, MD 886-2-23123456 ext 62394 jenkuang_lee@yahoo.com.tw
Taiwan
 
NCT01023360
200804034R
Yes
Chiang Fu-Tien, PhD, National Taiwan University Hospital
National Taiwan University Hospital
Haemonetics Corporation
Principal Investigator: Fu-Tien Chiang, MD, Phd National Taiwan University Hospital
National Taiwan University Hospital
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP