Antiplatelet Response, Interval Variability & Events in Percutaneous Coronary Intervention (ARIVE-PCI) Registry (ARIVE-PCI)
Subjects in this study have recently had or are scheduled for a percutaneous coronary intervention (PCI) as part of their normal, routine medical care. This procedure should restore the blood flow in the vessels of the heart.
One complication that can occur after a PCI procedure is blood clotting and narrowing of the artery in the area that was treated. This can result in a decrease in the blood flow to the heart. To avoid this complication, patients are given antiplatelet or "blood-thinning" drugs such as aspirin and clopidogrel as part of their routine care after this procedure.
For this research study, the investigators would like to take blood samples from subjects at 3 different time points while they are taking these antiplatelet drugs. The investigators will study the subjects' blood and medical history to help us further our understanding of how these drugs respond in individuals and in certain patient populations. Everyone responds a little differently to medications due to many reasons including our genetic make-up. Genes are passed down from our parents and determine our physical appearance such as the color of our hair and eyes. Differences in our genes may also help explain why some drugs work in some people, but not in others. By studying subjects' blood, medical history, genetic make-up and by recording how the subjects' blood responds over the course of their treatment, the investigators hope to learn more about how our bodies respond when taking these drugs. Additionally, the investigators hope to find better ways to predict who will respond more effectively to these drugs and better ways to monitor how these drugs are working in patients' bodies over time after PCI procedures.
Coronary Artery Disease
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Incidence, Predictors and Impact of Response Variability to Oral Dual Antiplatelet Therapy, as Measured by Point-of-care Platelet Aggregometry, Following Percutaneous Coronary Intervention|
- The primary endpoint of the study is occurrence of significant interval thienopyridine response variability and/or inhibition of platelet aggregation (IPA)) measured at study entry vs. 1 week vs. 1 month following oral thienopyridine load. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- The co-primary endpoint is occurrence of absolute thienopyridine hyporesponse at any of the specified timepoints. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- The secondary endpoint of the study explores the relationship between CYP 2C19 genotypes (ultra-rapid and extensive metabolizers vs. intermediate and poor metabolizers) and thienopyridine response / response variability. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Exploratory analyses will assess correlation between point-of-care platelet aggregometry (VerifyNow) and laboratory-based assessment of platelet function via Light Transmittance Aggregometry (LTA). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Additional analysis will explore the correlation between antiplatelet response to aspirin (ASA) and thienopyridines with incident major adverse cardiac events (MACE) and bleeding events during a 6 month follow-up period. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278043
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Sandeep Nathan, MD||University of Chicago|