Implementing Precision Medicine Approaches to Guide Anti-platelet Selection

Status unconfirmed · Phase 4

Conditions studied: Acute Coronary Syndrome (ACS), STEMI - ST Elevation Myocardial Infarction (MI), NSTEMI - Non-ST Segment Elevation MI, Unstable Angina (UA)

In brief

The study aims to determine the feasibility and clinical utility of incorporating precision medicine approaches, incorporating both cytochrome P450 2C19 (CYP2C19) genotyping and platelet reactivity phenotyping, with standard of care for patients with acute coronary syndromes (ACS), post PCI.

Key facts

Study ID

NCT04090281

Run by

University of Southern California

People needed

200

Starts

2020-03-13

Expected to finish

2023-11-30

Last updated by the study team

2021-09-28

Who can join

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

You may qualify if…

• Patients with troponin positive ACS
• Patients scheduled for left heart catheterization and undergoing PCI
• Age 18-80 years at time of enrollment
• Currently receiving or anticipated to receive DAPT, with P2Y12 inhibitor
• Ability to follow-up for a clinic visit with LAC+USC outpatient cardiology
• Written informed consent

You may not qualify if…

• Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage
• Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage, and a history of prior transient ischemic attack (TIA) or stroke
• Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to enrolling in this study. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i. v. catecholamines) for ≥7 days.
• Subjects requiring concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban)
• Indication for major surgery (per decision of the treating physician) for the planned duration of the study
• Subject with history of liver transplant or plan to undergo liver transplant during the next 12 months
• Evidence of significant active neuropsychiatric disease, in the investigator's opinion.

Where it is running

• LAC+USC Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.