Status:
COMPLETED
Evaluation and Comparison of Several Point-of-care Platelet Function Tests in Predicting Clinical Outcomes in Clopidogrel Pre-treated Patients Undergoing Elective PCI.
Lead Sponsor:
R&D Cardiologie
Conditions:
Stable Angina Pectoris
Eligibility:
All Genders
21+ years
Brief Summary
The purpose of this study is to investigate whether the level of Platelet Inhibition as assessed with five point-of-care platelet function assays correlates with clinical (periprocedural) outcomes suc...
Detailed Description
Antiplatelet agents-aspirin, thienopyridines, and platelet glycoprotein IIb/IIIa (GpIIb/IIIa) inhibitors-have become cornerstones in the treatment of ischemic heart disease for patients undergoing per...
Eligibility Criteria
Inclusion
- Coronary artery disease with objective evidence of ischemia (e.g., symptoms of angina pectoris, positive results of a stress test or dynamic electrocardiographic \[ECG\] changes)
- Adequate Aspirin and Clopidogrel pre-treatment.( Adequate clopidogrel pre-treatment is defined as a 600 mg loading dose of clopidogrel at least 6 hours prior to the PCI-procedure or a 300 mg loading dose of clopidogrel \>24 hours prior to the PCI-procedure or a 75 mg dose of clopidogrel for at least \>5 days prior to the PCI procedure
- Patient is thought to be at a high likelihood for requiring PCI (significant angiographic lesions in native coronary arteries amenable to and requiring a percutaneous coronary intervention)
- A stent (either drug-eluting or bare metal) is planned to be placed in at least one lesion.
- Written Informed consent
Exclusion
- ST-segment elevation Acute Myocardial Infarction (ST-segment ≥0.1mV in ≥2 contiguous ECG leads persisting for at least 20 minutes) within 48 hours from symptom onset.
- Contraindications to antithrombotic/antiplatelet therapy
- Failed coronary intervention in the previous 2 weeks
- Malignancies
- Increased risk of bleeding (previous stroke in the past months, active bleeding or bleeding diathesis, recent trauma or major surgery in the last month, suspected aortic dissection, oral anticoagulation therapy with coumarin derivate within 7 days, recent use of GPIIb/IIIa inhibitors within 14 days, severe uncontrolled hypertension \>180 mmHg unresponsive to therapy)
- Relevant hematologic deviations (hemoglobin \<100g/L (6,2 mmol/L) or hematocrit \<34%, platelet count \<100 x 109 /L or platelet count \> 600 x 109/L)
- Known allergy to clopidogrel
- Pregnancy (present or suspected)
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00352014
Start Date
January 1 2006
End Date
May 1 2008
Last Update
April 11 2018
Active Locations (1)
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1
Department of Cardiology, St. Antonius Hospital, The Netherlands
Nieuwegein, Utrecht, Netherlands, 3435 CM