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.

Study Overview

• Status: Unknown
• Conditions: 30 Healthy People
• Intervention / Treatment: Drug: Clopidogrel and proton pump inhibitors

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Fu-Tien Chiang, MD, PhD; Phone Number: 62150 886-2-23123456; Email: futienc@ntu.edu.tw
• Study Contact Backup: Name: Jen-Kuang Lee, MD; Phone Number: 62394 886-2-23123456; Email: jenkuang_lee@yahoo.com.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Fu-Tien Chiang, MD, PhD; Phone Number: 62150 886-2-23123456; Email: futienc@ntu.edu.tw
    • Contact: Jen-Kuang Lee, MD; Phone Number: 62394 886-2-23123456; Email: jenkuang_lee@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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: esomeprazole; clopidogrel; pantoprazole; rabeprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of the antiplatelet drug response apparently shown in TEG & Platelet mapping assay	6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Haemonetics Corporation
• Investigators: Principal Investigator: Fu-Tien Chiang, MD, Phd, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ANTICIPATED): October 1, 2010
• Study Completion (ANTICIPATED): October 1, 2010

Study Registration Dates

• First Submitted: August 7, 2008
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (ESTIMATE): December 2, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2009
• Last Update Submitted That Met QC Criteria: December 1, 2009
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Gastrointestinal Agents; Anti-Ulcer Agents; Clopidogrel; Rabeprazole; Esomeprazole; Pantoprazole; Proton Pump Inhibitors
• Other Study ID Numbers: 200804034R