Coronary Artery Disease Clinical Trial
Official title:
IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel
Verified date | July 2020 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).
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. |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Health Methodist Hospital | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
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 |
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