An observational study in Increased Drug Resistance, sponsored by Medstar Health Research Institute. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-11.
Sponsored by Medstar Health Research Institute · Observational
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).
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.
Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
1000 patients, male or female, older than 18 years of age, who are scheduled for or underwent percutaneous coronary intervention (PCI) or CABG and have been treated with a loading dose of a thienopyridine or on a maintenance dose of a thienopyridine.
Exclusion Criteria:
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.
Aspirin resistance will be measured by the VerifyNow aspirin resistance assay.
The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.
The prevalence and degree of thienopyridine resistance
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
Time frame: Duration of hospital stay; average hospital stay of less than 48 hours
The prevalence of aspirin resistance
The prevalence and degree of aspirin resistance will be measured by the VerifyNow aspirin resistance assay.
Time frame: Duration of hospital stay; average hospital stay of less than 48 hours
Correlate levels of platelet reactivity with the presence of selected genetic polymorphisms
The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.
Time frame: Duration of hospital stay; average hospital stay of less than 48 hours
This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Medstar Health Research Institute