Implementing Precision Medicine Approaches to Guide Anti-platelet Selection

NCT ID: NCT04090281

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-13
• Study Completion Date: 2023-11-30

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 phenotyping, with standard of care for patients with acute coronary syndromes (ACS), post PCI.

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:

Overview of clinical protocol: Patients with successful PCI will receive a genotype guided recommendation, upon discharge, based on CYP2C19 genotype. Patients who are determined to have CYP2C19 poor metabolizer (PM) or intermediate metabolizer (IM) status will be recommended to receive 12-months of prasugrel. Patients who are determined to have CYP2C19 normal metabolizer (NM), rapid metabolizer (RM), or ultra-rapid metabolizer (UM) phenotype will be recommended to receive a de-escalation treatment, guided by on-treatment platelet reactivity phenotype at 14 days, post discharge.

30-day, 6-month, and 12-month Follow-up: Patients will be contacted by phone or visited during one of their regularly scheduled appointments, at 14 days, 30 days, 6 months , and 12 months, to complete "Follow-up Case Report Forms" to collect outcomes data. The 12-month follow up communication with enrolled patients will end their participation in the study.

Conditions

Acute Coronary Syndrome (ACS); STEMI - ST Elevation Myocardial Infarction (MI); NSTEMI - Non-ST Segment Elevation MI; Unstable Angina (UA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Precision medicine implementation

Patients will receive a precision medicine approach, incorporating both CYP2C19 genotyping and platelet reactivity phenotyping, to guide dual antiplatelet therapy selection for patients with ACS, post PCI and followed over a 12 month period.

Group Type: OTHER

CYP2C19 genotyping

Intervention Type: GENETIC

Upon hospital discharge, patients will undergo CYP2C19 genotyping to guide initial P2Y12 inhibitor selection. At 14 days, post discharge, patients will undergo on treatment platelet reactivity phenotyping to further guide deescalation of P2Y12 inhibitor therapy

Interventions

CYP2C19 genotyping

Upon hospital discharge, patients will undergo CYP2C19 genotyping to guide initial P2Y12 inhibitor selection. At 14 days, post discharge, patients will undergo on treatment platelet reactivity phenotyping to further guide deescalation of P2Y12 inhibitor therapy

Intervention Type: GENETIC

Other Intervention Names

platelet reactivity phenotyping

Eligibility Criteria

Inclusion Criteria

1. Patients with troponin positive ACS

2. Patients scheduled for left heart catheterization and undergoing PCI

3. Age 18-80 years at time of enrollment

4. Currently receiving or anticipated to receive DAPT, with P2Y12 inhibitor

5. Ability to follow-up for a clinic visit with LAC+USC outpatient cardiology

6. Written informed consent

Exclusion Criteria

1. 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

2. 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

3. 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.

4. Subjects requiring concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban)

5. Indication for major surgery (per decision of the treating physician) for the planned duration of the study

6. Subject with history of liver transplant or plan to undergo liver transplant during the next 12 months

7. Evidence of significant active neuropsychiatric disease, in the investigator's opinion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Scott Mosley, PharmD

Assistant Professor of Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott A Mosley, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California School of Pharmacy

Locations

LAC+USC Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

APP-19-00099

Identifier Type: -

Identifier Source: org_study_id