IU Health Krannert Personalized Medicine Study

Not Applicable

Terminated

• Conditions: Coronary Artery Disease

• Registration Number: NCT02955121
• Lead Sponsor: Indiana University

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-10-07
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Primary Completion: 2019-08-09
• Study Completion: 2020-01-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in prescription of antiplatelet therapy	one year	Number of individuals whose initial P2Y12 inhibitor therapy was changed to another P2Y12 inhibitor during time of follow up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States