Assessment of Prospective CYP2C19 Genotype Guided Dosing of Anti-Platelet Therapy in Percutaneous Coronary Intervention

Completed · Not applicable

Conditions studied: Acute Coronary Syndrome, Cardiovascular Diseases

In brief

This is a randomized, prospective, open label study to determine the cost-effectiveness of genotype-guided antiplatelet therapy. Patients undergoing percutaneous intervention (PCI) with stent implantation, will be randomized either to genotype guided dosing of antiplatelet therapy or usual care. The study utilizes a novel genotyping device, SpartanRx, to determine CYP2C19 genotypes from a buccal swab sample with 1 hour turnaround time.

Key facts

Study ID

NCT02508116

Run by

University of Pennsylvania

People needed

509

Starts

2014-11-01

Expected to finish

2017-08-01

Last updated by the study team

2018-11-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects, ≥18 to ≤80 years at time of study
• Status post PCI with stent implantation requiring antiplatelet therapy
• Willingness to comply with all study-related procedures

You may not qualify if…

• Pending imminent surgery placing patients at increased risk for bleeding with prasugrel or ticagrelor.
• History of intracranial hemorrhage, TIA, and stroke
• Active bleeding
• Need for long-term anticoagulation (i.e. warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, or lovenox).
• Current or prior (within the past four weeks) treatment with voraxapar (Zontivity).
• Severe renal or hepatic impairment
• Treating physician does not want subject to participate
• Drug allergy to clopidogrel, prasugrel or ticagrelor.

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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