Back to resultsIU Health Krannert Personalized Medicine Study
Primary Purpose
Coronary Artery Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prescriber Access to Genetic Information
Sponsored by
About this trial
This is an interventional health services research trial for Coronary Artery Disease focused on measuring Cytochrome P-450 CYP2C19, Pharmacogenetics, Platelet Aggregation Inhibitors, Percutaneous Coronary Intervention
Eligibility Criteria
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.
Sites / Locations
- Indiana University Health Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Pharmacogenetic Results Available to Provider
Control Arm
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Death, Myocardial Infarction, Stroke
Combined incidence of either death, myocardial infarction or stroke during follow up
Stent Thrombosis
Combined incidence of stent thrombosis according to Academic Research Consortium definitions during follow up
Urgent target vessel revascularization
Incidence of urgent target revascularization
Major and Minor Bleeding
Incidence of Major or Minor Bleeding according to GUSTO criteria during follow up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02955121
Brief Title
IU Health Krannert Personalized Medicine Study
Official Title
IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Slower than anticipated recruitment
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 9, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Cytochrome P-450 CYP2C19, Pharmacogenetics, Platelet Aggregation Inhibitors, Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacogenetic Results Available to Provider
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Prescriber Access to Genetic Information
Primary Outcome Measure Information:
Title
Change in prescription of antiplatelet therapy
Description
Number of individuals whose initial P2Y12 inhibitor therapy was changed to another P2Y12 inhibitor during time of follow up
Time Frame
one year
Secondary Outcome Measure Information:
Title
Death, Myocardial Infarction, Stroke
Description
Combined incidence of either death, myocardial infarction or stroke during follow up
Time Frame
one year
Title
Stent Thrombosis
Description
Combined incidence of stent thrombosis according to Academic Research Consortium definitions during follow up
Time Frame
one year
Title
Urgent target vessel revascularization
Description
Incidence of urgent target revascularization
Time Frame
one year
Title
Major and Minor Bleeding
Description
Incidence of Major or Minor Bleeding according to GUSTO criteria during follow up
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Kreutz, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified Data Sharing only
Learn more about this trial
IU Health Krannert Personalized Medicine Study
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