Status:
UNKNOWN
Implementing Precision Medicine Approaches to Guide Anti-platelet Selection
Lead Sponsor:
University of Southern California
Conditions:
Acute Coronary Syndrome (ACS)
STEMI - ST Elevation Myocardial Infarction (MI)
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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 ph...
Detailed Description
Study Population: Adult patients will be eligible for inclusion if they provide informed consent and have no contraindications for 12-months of dual antiplatelet therapy (DAPT). Baseline Evaluation:...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04090281
Start Date
March 13 2020
End Date
November 30 2023
Last Update
September 28 2021
Active Locations (1)
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1
LAC+USC Medical Center
Los Angeles, California, United States, 90033