NCT01408927

Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary Percutaneous Coronary Intervention or Coronary Artery Bypass Graft Population

Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary PCI and CABG Population

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population undergoing contemporary percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).

Detailed description

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.

Conditions

• Increased Drug Resistance

Interventions

Type	Name	Description
OTHER	Thienopyridine resistance testing	Thienopyridine resistance will be measured by flow cytometry of vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and/or VerifyNow P2Y12 assay, and/or the Chrono-Log Lumi-Aggregometer, and/or the PlaCor PRT 7000 platelet reactivity assay.
OTHER	Aspirin resistance testing	Aspirin resistance will be measured by the VerifyNow aspirin resistance assay.
OTHER	Genetic polymorphism assessment	The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.

Timeline

• Start date: 2008-10-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2011-08-03
• Last updated: 2014-08-11

Locations

1 site across 1 country: United States