Evaluation and Comparison of Several Point-of-Care Platelet Function Tests in Predicting Clinical Outcomes in Clopidogrel Pre-Treated Patients Undergoing Elective PCI.
Recruitment status was Recruiting
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.
Stable Angina Pectoris
|Study Design:||Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
|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|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352014
|Contact: Jurrien M. ten Berg, MD, PhDfirstname.lastname@example.org|
|Contact: Jochem W. van Werkum, MDemail@example.com|
|Department of Cardiology, St. Antonius Hospital, The Netherlands||Recruiting|
|Nieuwegein, Utrecht, Netherlands, 3435 CM|
|Contact: Jurrien M ten Berg, MD, PhD 0031-31-6099111 firstname.lastname@example.org|
|Contact: Jochem W van Werkum, MD 0031-30-6099111 email@example.com|
|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|