Platelet Function Assessment for Atherothrombotic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00513149
First received: August 6, 2007
Last updated: January 20, 2011
Last verified: January 2011
  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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513149

Contacts
Contact: Tzung-Dau Wang, M.D.,Ph.D. 886-2-23123456 ext 5632 tdwang@ntu.edu.tw

Locations
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         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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 August 27, 2014