IU Health Krannert Personalized Medicine Study

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02955121
• Other study ID #: 1408765880
• Status: Terminated
• Phase: N/A
• Start date: November 2016
• Est. completion date: January 15, 2020

Study information

• Verified date: July 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: January 15, 2020
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Other:
• Prescriber Access to Genetic Information

Locations

Country	Name	City	State
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

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