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Implementing Precision Medicine Approaches to Guide Anti-platelet Selection

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ClinicalTrials.gov Identifier: NCT04090281
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Scott Mosley, PharmD, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome (ACS) STEMI - ST Elevation Myocardial Infarction (MI) NSTEMI - Non-ST Segment Elevation MI Unstable Angina (UA) Genetic: CYP2C19 genotyping Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single-center, single arm, pragmatic study to determine feasibility of intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementing Precision Medicine Approaches to Guide Anti-platelet Selection Following Percutaneous Coronary Intervention (PCI)
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

Arm Intervention/treatment
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.
Genetic: 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
Other Name: platelet reactivity phenotyping




Primary Outcome Measures :
  1. Feasibility of implementing pharmacogenetics to guide antiplatelet therapy [ Time Frame: 12 months ]
    The proportion of patients in whom a genetic-guided recommendation is accepted by the clinician

  2. Feasibility of implementing platelet reactivity testing to guide de-escalation of antiplatelet therapy [ Time Frame: 12 months ]
    The proportion of patients in whom a platelet reactivity phenotype-guided recommendation is accepted by the clinician


Secondary Outcome Measures :
  1. Net clinical utility [ Time Frame: 30 days ]
    The incidence of combined endpoints of major adverse cardiovascular events (MACE), stent thrombosis, unstable angina, major and minor bleeding, all-cause mortality, and hospital readmission rate within 30 days, post discharge

  2. Net clinical utility [ Time Frame: 12 months ]
    The incidence of combined endpoints of MACE, stent thrombosis, unstable angina, major and minor bleeding, all-cause mortality, and hospital readmission rate within 12 months, post discharge

  3. Change in score of anxiety using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) [ Time Frame: 30 days ]
    Patient Reported Outcomes Measurement Information System (PROMIS) subscale for anxiety include fear, anxiety, worry, and uneasiness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.

  4. Change in score of anxiety using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) [ Time Frame: 12 months ]
    Patient Reported Outcomes Measurement Information System (PROMIS) subscale for anxiety include fear, anxiety, worry, and uneasiness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.

  5. Change in score of depression using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) [ Time Frame: 30 days ]
    Patient Reported Outcomes Measurement Information System (PROMIS) subscale for depression include worthless, helpless, depressed, and hopelessness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.

  6. Change in score of depression using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) [ Time Frame: 12 months ]
    Patient Reported Outcomes Measurement Information System (PROMIS) subscale for depression include worthless, helpless, depressed, and hopelessness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.

  7. Change in score of social abilities using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) [ Time Frame: 30 days ]
    Patient Reported Outcomes Measurement Information System (PROMIS) subscale for social abilities include leisure, family, usual work, and friends. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.

  8. Change in score of social abilities using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale) [ Time Frame: 12 months ]
    Patient Reported Outcomes Measurement Information System (PROMIS) subscale for social abilities include leisure, family, usual work, and friends. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090281


Contacts
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Contact: Scott A Mosley, PharmD 3234420355 samosley@usc.edu
Contact: Tien Ng, PharmD 3234421840 tienng@usc.edu

Locations
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United States, California
LAC+USC Medical Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Scott A Mosley, PharmD    323-442-0355    samosley@usc.edu   
Contact: Tien Ng, PharmD    3234421840    tienng@usc.edu   
Principal Investigator: Scott A Mosley, PharmD         
Sub-Investigator: Tien Ng, PharmD         
Sub-Investigator: Leonardo Clavijo, MD, PhD         
Sub-Investigator: David Shavelle, MD         
Sub-Investigator: Samantha Yeung, PharmD         
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Scott A Mosley, PharmD University of Southern California School of Pharmacy

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Responsible Party: Scott Mosley, PharmD, Assistant Professor of Clinical Pharmacy, University of Southern California
ClinicalTrials.gov Identifier: NCT04090281     History of Changes
Other Study ID Numbers: APP-19-00099
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Scott Mosley, PharmD, University of Southern California:
precision medicine
antiplatelet
pharmacogenetics
de-escalation
dual antiplatelet therapy (DAPT)
percutaneous coronary intervention (PCI)
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Angina, Unstable
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms