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Sponsored by: |
R&D Cardiologie |
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Information provided by: | R&D Cardiologie |
ClinicalTrials.gov Identifier: | NCT00352014 |
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 such as Acute Myocardial Infarction, death, Target Vessel revascularization and/or stroke in patients undergoing elective PCI.
Condition |
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Stable Angina Pectoris |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Official Title: | Do Point-of-Care Platelet Function Assays Predict Clinical Outcomes in Clopidogrel Pre-Treated Patients Undergoing Elective PCI. (The POPular Study) |
Estimated Enrollment: | 1000 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | May 2008 |
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jurrien M. ten Berg, MD, PhD | 0031-30-6099111 | berg03@antonius.net |
Contact: Jochem W. van Werkum, MD | 0031-30-609111 | w.van.werkum@antonius.net |
Netherlands, Utrecht | |
Department of Cardiology, St. Antonius Hospital, The Netherlands | Recruiting |
Nieuwegein, Utrecht, Netherlands, 3435 CM | |
Contact: Jurrien M ten Berg, MD, PhD 0031-31-6099111 berg03@antonius.net | |
Contact: Jochem W van Werkum, MD 0031-30-6099111 w.van.werkum@antonius.net | |
Sub-Investigator: Jochem W van Werkum, MD | |
Sub-Investigator: Christian M Hackeng, PhD |
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 |
Study ID Numbers: | Z-05.13 |
Study First Received: | July 13, 2006 |
Last Updated: | July 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00352014 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Monitoring of antiplatelet therapy antiplatelet therapy platelet function assays |
Aspirin Clopidogrel elective PCI |
Signs and Symptoms Heart Diseases Aspirin Clopidogrel Myocardial Ischemia |
Vascular Diseases Angina Pectoris Pain Ischemia Chest Pain |
Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |