Evaluation and Comparison of Several Point-of-care Platelet Function Tests in Predicting Clinical Outcomes in Clopidogrel Pre-treated Patients Undergoing Elective PCI.
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| ClinicalTrials.gov Identifier: NCT00352014 |
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Recruitment Status :
Completed
First Posted : July 14, 2006
Last Update Posted : April 11, 2018
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| Condition or disease |
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| Stable Angina Pectoris |
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 percutaneous coronary intervention (PCI)1,2. However, several studies have demonstrated with the use of platelet function assays that subgroups of patients receiving either aspirin, clopidogrel, or both fail to produce the anticipated antiplatelet effect3-5. Consequently, terms like "aspirin-resistance" and "clopidogrel resistance" have been introduced in literature.
Light transmittance platelet aggregometry is generally considered to be the gold standard for determining platelet function, but its relevance to in vivo platelet function is questionable and the logistically demands of the method make it impossible to use in daily practice. In addition, aggregation is just one of several important platelet functions. The introduction of several point-of-care assays may be the key to the widespread clinical use of platelet function testing to identify so called anti-platelet therapy low-responders. However, whether these point-of-care platelet function tests provide predictive value (i.e. correlate with clinical outcomes) and the allocation of the "best" or most suitable point-of-care Platelet function assay to determine the level of inhibition of platelet function remains to be established.
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Time Perspective: | Prospective |
| Official Title: | Do Point-of-care Platelet Function Assays Predict Clinical Outcomes in Clopidogrel Pre-treated Patients Undergoing Elective PCI. (The POPular Study) |
| Study Start Date : | January 2006 |
| Actual Primary Completion Date : | May 2008 |
| Actual Study Completion Date : | May 2008 |
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352014
| Netherlands | |
| Department of Cardiology, St. Antonius Hospital, The Netherlands | |
| Nieuwegein, Utrecht, Netherlands, 3435 CM | |
| Principal Investigator: | Jurrien M ten Berg, MD, PhD | Department of Cardiology, St. Antonius Hospital Nieuwegein, The Netherlands | |
| Study Chair: | Jochem W van Werkum, MD | Department of Research and Development in Cardiology, St. Antonius Hospital Nieuwegein, The Netherlands | |
| Study Chair: | Christian M Hackeng, PhD | Department of Clinical Chemistry, Nieuwegein, St. Antonius Hospital The Netherlands |
| ClinicalTrials.gov Identifier: | NCT00352014 |
| Other Study ID Numbers: |
Z-05.13 |
| First Posted: | July 14, 2006 Key Record Dates |
| Last Update Posted: | April 11, 2018 |
| Last Verified: | April 2018 |
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Monitoring of antiplatelet therapy antiplatelet therapy platelet function assays |
Aspirin Clopidogrel elective PCI |
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Angina Pectoris Angina, Stable Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Neurologic Manifestations Signs and Symptoms |