Platelet Function Assessment for Atherothrombotic Patients
Validation of the Clinical Applicability of Various Platelet Function Assessments in High-Risk Atherothrombotic Patients Undergoing Percutaneous Coronary Angioplasty: Phase 4 Study
1 other identifier
interventional
150
1 country
1
Brief Summary
Background-Despite the pivotal pathogenic role of platelets in atherothrombosis has been widely recognized, there is a striking lack of consensus regarding how to measure platelet function and how to monitor the effects of various antiplatelet drugs. In view of the fact that recurrent ischemic events occurred in 8.5% to 8.8% of patients treated with dual antiplatelet drugs and there is significant inter-individual variability in platelet reactivity, we believe that the importance of platelet function assessment and its clinical implication should not be overlooked.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 coronary-artery-disease
Started Jul 2006
Longer than P75 for phase_4 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 6, 2007
CompletedFirst Posted
Study publicly available on registry
August 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJanuary 24, 2011
January 1, 2011
4.9 years
August 6, 2007
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the occurrence of major cardiovascular events (MACE)(death, myocardial infarction, stroke, and clinically driven target lesion revascularization)
1 year
Secondary Outcomes (3)
the correlations between various platelet parameters and coronary angiographic findings
1 year
the correlations among different platelet function measurements
1 year
the responsiveness of CADP-CT on high-dose clopidogrel loading
1 year
Study Arms (1)
c6
ACTIVE COMPARATORClopidogrel 600 mg loading
Interventions
Eligibility Criteria
You may qualify if:
- Coronary artery disease
You may not qualify if:
- History of bleeding diathesis
- History of drug or alcohol abuse or liver disease
- Abnormal prothrombin time
- Abnormal platelet count
- Serum creatinine \>1.5 mg/dl.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Department of Internal Medicine and Department of Medical Imaging, National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tzung-Dau Wang, M.D.,Ph.D.
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 6, 2007
First Posted
August 8, 2007
Study Start
July 1, 2006
Primary Completion
June 1, 2011
Study Completion
July 1, 2011
Last Updated
January 24, 2011
Record last verified: 2011-01