IU Health Krannert Personalized Medicine Study

IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel

Randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Prescriber Access to Genetic Information

Detailed Description

The study will randomize patients who have completed PCI and who are prescribed dual antiplatelet therapy to a genotype guided arm, in which CYP2C19 pharmacogenetic testing will be performed and a standard therapy arm without genetic testing. The study will examine the impact of pharmacogenetic testing on physician medication choice and clinical outcomes.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with ischemic heart disease, who are prescribed dual antiplatelet therapy after percutaneous coronary intervention (PCI). Enrollment has to occur during index hospitalization or during outpatient visit for cath lab procedure.

Exclusion Criteria:

• Pregnant or breastfeeding.
• Unwilling or unable, in the opinion of the investigator, to comply with instructions on prescribed medicines.
• Prior known allergy or intolerance to clopidogrel.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pharmacogenetic Results Available to Provider; Genotyping for CYP2C19 variants is performed. The test results are integrated into the electronic health record and alerts are displayed to the prescriber. The ultimate decision regarding antiplatelet therapy is left to the prescriber	Other: Prescriber Access to Genetic Information
No Intervention: Control Arm; No genotyping information is performed as part of clinical care. Standard therapy is followed. Genotyping will be performed at conclusion of study in control arm, and genotyping results will not be incorporated into electronic health record.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in prescription of antiplatelet therapy	Number of individuals whose initial P2Y12 inhibitor therapy was changed to another P2Y12 inhibitor during time of follow up	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death, Myocardial Infarction, Stroke	Combined incidence of either death, myocardial infarction or stroke during follow up	one year
Stent Thrombosis	Combined incidence of stent thrombosis according to Academic Research Consortium definitions during follow up	one year
Urgent target vessel revascularization	Incidence of urgent target revascularization	one year
Major and Minor Bleeding	Incidence of Major or Minor Bleeding according to GUSTO criteria during follow up	one year

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Rolf Kreutz, MD, Indiana University

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): August 9, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimate): November 4, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Pharmacogenetics; Platelet Aggregation Inhibitors; Cytochrome P-450 CYP2C19
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 1408765880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified Data Sharing only