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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
History of Changes
  Purpose

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.


Condition Intervention Phase
30 Healthy People
 Drug: Clopidogrel and proton pump inhibitors
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping™ Assay

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Comparison of the antiplatelet drug response apparently shown in TEG & Platelet mapping assay [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023360

Contacts
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

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
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    
Sponsors and Collaborators
National Taiwan University Hospital
Haemonetics Corporation
Investigators
Principal Investigator: Fu-Tien Chiang, MD, Phd National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Chiang Fu-Tien, PhD, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01023360     History of Changes
Other Study ID Numbers: 200804034R
Study First Received: August 7, 2008
Last Updated: December 1, 2009
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Omeprazole
Pantoprazole
Rabeprazole
Clopidogrel
Platelet Aggregation Inhibitors
Ticlopidine
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013