Platelet Function Assessment for Atherothrombotic Patients
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Clopidogrel |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Validation of the Clinical Applicability of Various Platelet Function Assessments in High-Risk Atherothrombotic Patients Undergoing Percutaneous Coronary Angioplasty: Phase 4 Study |
- the occurrence of major cardiovascular events (MACE)(death, myocardial infarction, stroke, and clinically driven target lesion revascularization) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- the correlations between various platelet parameters and coronary angiographic findings [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- the correlations among different platelet function measurements [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- the responsiveness of CADP-CT on high-dose clopidogrel loading [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: c6
Clopidogrel 600 mg loading
|
Drug: Clopidogrel
Clopidogrel 600 mg loading
Other Name: clopidogrel
|
Detailed Description:
Methods and Expected Results—In this prospective follow-up study, we will assess the predictive power of different assays of platelet function (PFA-100, plasma levels of von Willebrand factor, P-selectin, soluble CD40 ligand, and myeloid-related protein-8/14, and ADP-induced P-selectin [CD62P] expression on platelets by flow cytometry) before and after high-dose (600 mg) clopidogrel loading, at 3-month follow-up, and at study end on the occurrence of major cardiovascular events (MACE)(death, myocardial infarction, stroke, and coronary revascularization). We will also evaluate the correlations between different assays of platelet function. Based on our previous pilot study which demonstrated that a significant association between collagen-ADP closure time measured by PFA-100 and the occurrence of major cardiovascular events in 130 patients undergoing coronary angioplasty followed up for 6 months, we plan to include 150-200 patients into the present study. The total inclusion period is estimated to be 1 year. Therefore, a total of 2 to 2.5 years will be needed to complete this study. In the first year, we will analyze (1) the correlations between various platelet parameters and coronary angiographic findings; (2) the correlations among different platelet function measurements; and (3) the responsiveness of CADP-CT on high-dose clopidogrel loading.
In the second year, we will (1) analyze the predictability of various platelet parameters, at different point of time (baseline, after clopidogrel loading, at study end), on the occurrence of MACE and (2) establish a risk-prediction schema for patients undergoing coronary angioplasty. A pre-defined threshold value for the collagen-epinephrine closure time is set at 190 s, since this value has been recommended by other investigators to differentiate the presence or absence of aspirin resistance. A pre-defined threshold value for the collagen-ADP closure time is set at 90 s, since we found in our pilot study that this value was associated with the best discriminating ability for identifying patients developing MACE. In the third year, genetic background determining the PFA-100 closure time and levels of plasma markers of platelet activation will be explored by analyzing the relationships between various SNP/haplotype patterns and values of different platelet function assessments.
Clinical Significance—The present study will be the first to explore the clinical role of platelet function assessment both at baseline, after high-dose clopidogrel loading, and at study end. It may give us great insights regarding how to treat high-risk patients adequately with antiplatelet agents.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Coronary artery disease
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Tzung-Dau Wang, M.D.,Ph.D. | 886-2-23123456 ext 5632 | tdwang@ntu.edu.tw |
| Taiwan | |
| Division of Cardiology, Department of Internal Medicine and Department of Medical Imaging, National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Tzung-Dau Wang, MD, PhD 886-2-2312-3456 ext 5632 tdwang@ha.mc.ntu.edu.tw | |
| Principal Investigator: Tzung-Dau Wang, MD, PhD | |
| Study Chair: | Tzung-Dau Wang, M.D.,Ph.D. | National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | Tzung-Dau Wang, M.D., Ph.D., NTUH |
| ClinicalTrials.gov Identifier: | NCT00513149 History of Changes |
| Other Study ID Numbers: | 200612040R |
| Study First Received: | August 6, 2007 |
| Last Updated: | January 20, 2011 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
angioplasty clopidogrel coronary artery disease PFA |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Clopidogrel Ticlopidine Platelet Aggregation Inhibitors Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013