Implementing Precision Medicine Approaches to Guide Anti-platelet Selection

NCT04090281 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: APP-19-00099
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

precision medicine; antiplatelet; pharmacogenetics; de-escalation; dual antiplatelet therapy (DAPT); percutaneous coronary intervention (PCI)

Outcome Measures

Primary Outcomes (2)

• Feasibility of implementing pharmacogenetics to guide antiplatelet therapy

  The proportion of patients in whom a genetic-guided recommendation is accepted by the clinician

  12 months

• Feasibility of implementing platelet reactivity testing to guide de-escalation of antiplatelet therapy

  The proportion of patients in whom a platelet reactivity phenotype-guided recommendation is accepted by the clinician

  12 months

Secondary Outcomes (8)

• Net clinical utility

  30 days

• Net clinical utility

  12 months

• Change in score of anxiety using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)

  30 days

• Change in score of anxiety using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)

  12 months

• Change in score of depression using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)

  30 days

Study Arms (1)

Precision medicine implementation

OTHER

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.

Genetic: CYP2C19 genotyping

Interventions

CYP2C19 genotyping 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

Also known as: platelet reactivity phenotyping

Precision medicine implementation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

LAC+USC Medical Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Scott A Mosley, PharmD

  University of Southern California School of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pharmacy

Model Details: Prospective, single-center, single arm, pragmatic study to determine feasibility of intervention

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 16, 2019
• Study Start: March 13, 2020
• Primary Completion: May 31, 2023
• Study Completion: November 30, 2023
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Study protocol is anticipated to be published within 12 months of completing the study, and not anticipated to have a time limit.

Locations

US (1)