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

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ClinicalTrials.gov Identifier: NCT01023360
Recruitment Status : Unknown
Verified June 2008 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Sponsor:
Collaborator:
Haemonetics Corporation
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE August 7, 2008
First Posted Date  ICMJE December 2, 2009
Last Update Posted Date December 2, 2009
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
Comparison of the antiplatelet drug response apparently shown in TEG & Platelet mapping assay [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping ™ Assay
Official Title  ICMJE Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping™ Assay
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE 30 Healthy People
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2010
Estimated Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01023360
Other Study ID Numbers  ICMJE 200804034R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chiang Fu-Tien, PhD, National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Haemonetics Corporation
Investigators  ICMJE
Principal Investigator: Fu-Tien Chiang, MD, Phd National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date June 2008

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