Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352014
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2006-07-13
Brief Title:
Evaluation and Comparison of Several Point-of-care Platelet Function Tests in Predicting Clinical Outcomes in Clopidogrel Pre-treated Patients Undergoing Elective PCI
Sponsor:
RD Cardiologie
Organization:
RD Cardiologie
Study Overview
Official Title:
Do Point-of-care Platelet Function Assays Predict Clinical Outcomes in Clopidogrel Pre-treated Patients Undergoing Elective PCI The POPular Study
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 such as Acute Myocardial Infarction death Target Vessel revascularization andor stroke in patients undergoing elective PCI
Detailed Description:
Antiplatelet agents-aspirin thienopyridines and platelet glycoprotein IIbIIIa GpIIbIIIa inhibitors-have become cornerstones in the treatment of ischemic heart disease for patients undergoing percutaneous coronary intervention PCI12 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None