Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary Percutaneous Coronary Intervention or Coronary Artery Bypass Graft Population (VASP)
|ClinicalTrials.gov Identifier: NCT01408927|
Recruitment Status : Unknown
Verified August 2014 by Medstar Health Research Institute.
Recruitment status was: Recruiting
First Posted : August 3, 2011
Last Update Posted : August 11, 2014
|Condition or disease||Intervention/treatment|
|Increased Drug Resistance||Other: Thienopyridine resistance testing Other: Aspirin resistance testing Other: Genetic polymorphism assessment|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary PCI and CABG Population|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2016|
Other: Thienopyridine resistance testing
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|