IU Health Krannert Personalized Medicine Study

NCT02955121 | Terminated

• 1 other identifier: 1408765880
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Cytochrome P-450 CYP2C19; Pharmacogenetics; Platelet Aggregation Inhibitors; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Death, Myocardial Infarction, Stroke

  one year

• Stent Thrombosis

  one year

• Urgent target vessel revascularization

  one year

• Major and Minor Bleeding

  one year

Study Arms (2)

Pharmacogenetic Results Available to Provider

ACTIVE COMPARATOR

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

Control Arm

NO INTERVENTION

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.

Interventions

Prescriber Access to Genetic Information OTHER

Pharmacogenetic Results Available to Provider

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Rolf Kreutz, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: November 4, 2016
• Study Start: November 1, 2016
• Primary Completion: August 9, 2019
• Study Completion: January 15, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)