Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary Percutaneous Coronary Intervention or Coronary Artery Bypass Graft Population (VASP)
Recruitment status was: Recruiting
|Increased Drug Resistance||Other: Thienopyridine resistance testing Other: Aspirin resistance testing Other: Genetic polymorphism assessment|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary PCI and CABG Population|
- The prevalence and degree of thienopyridine resistance [ Time Frame: Duration of hospital stay; average hospital stay of less than 48 hours ]
Thienopyridine resistance will be assessed by:
oThe VASP assay, which measures the platelet reactivity index; and/or oThe VerifyNow P2Y12 receptor inhibition assay, which measures P2Y12 reaction units (PRU); and/or oThe Chrono-Log Lumi-Aggregometer, which measures platelet aggregation (via optical density or electrical impedance) in response to ADP stimulation; and/or oThe PlaCor PRT 7000 platelet reactivity assay
- The prevalence of aspirin resistance [ Time Frame: Duration of hospital stay; average hospital stay of less than 48 hours ]The prevalence and degree of aspirin resistance will be measured by the VerifyNow aspirin resistance assay.
- Correlate levels of platelet reactivity with the presence of selected genetic polymorphisms [ Time Frame: Duration of hospital stay; average hospital stay of less than 48 hours ]The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Other: Thienopyridine resistance testing
This is a prospective cohort study of 1000 patients presenting to the Washington Hospital Center for percutaneous coronary intervention or coronary artery bypass surgery.
The aim of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population presenting for cardiac catheterization and undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Thienopyridine resistance will be measured by flow cytometry of the vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and/or the VerifyNow P2Y12 assay, and/or the Chrono-Log Lumi-Aggregometer, and/or the PlaCor PRT 7000 platelet reactivity assay.
A secondary objective of this study is to correlate a variety of genetic polymorphisms with levels of platelet reactivity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408927
|Contact: Ron Waksman, MDemail@example.com|
|United States, District of Columbia|
|Washington Hospital Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Ron Waksman, MD 202-877-5975 firstname.lastname@example.org|
|Principal Investigator: Ron Waksman, MD|