Coronary Artery DiseaseNCT02955121
IU Health Krannert Personalized Medicine Study
A study testing Prescriber Access to Genetic Information in people with Coronary Artery Disease, run by Indiana University at 1 site in United States.
Trial summary
Randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Prescriber Access to Genetic Information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Official title: IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel
Randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Prescriber Access to Genetic Information
- Keywords
- Cytochrome P-450 CYP2C19, Pharmacogenetics, Platelet Aggregation Inhibitors, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescriber Access to Genetic InformationOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (4)
Death, Myocardial Infarction, Stroke
Combined incidence of either death, myocardial infarction or stroke during follow up
Measured: one year
Stent Thrombosis
Combined incidence of stent thrombosis according to Academic Research Consortium definitions during follow up
Measured: one year
Urgent target vessel revascularization
Incidence of urgent target revascularization
Measured: one year
Major and Minor Bleeding
Incidence of Major or Minor Bleeding according to GUSTO criteria during follow up
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion9 Aug 2019
- Study completion15 Jan 2020
Why it stopped: Slower than anticipated recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolf Kreutz, Indiana University
- Investigators
- Rolf Kreutz, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955121
- Sponsor's protocol ID
- 1408765880
- Status last verified
- Jul 2020
- First submitted
- 7 Oct 2016
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified Data Sharing only
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel
- ClinicalTrials.gov ID
- NCT02955121
- Acronym / sponsor ID
- 1408765880
- Conditions
- Coronary Artery Disease
- Keywords
- Cytochrome P-450 CYP2C19, Pharmacogenetics, Platelet Aggregation Inhibitors, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slower than anticipated recruitment
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenetic Results Available to Provider | Active comparator | Other: Prescriber Access to Genetic InformationGenotyping 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescriber Access to Genetic Information | Other | Pharmacogenetic Results Available to Provider |
Primary outcome
Change in prescription of antiplatelet therapy
Time frame: one year
Number of individuals whose initial P2Y12 inhibitor therapy was changed to another P2Y12 inhibitor during time of follow up
4 secondary outcomes
Death, Myocardial Infarction, Stroke
Time frame: one year
Stent Thrombosis
Time frame: one year
Urgent target vessel revascularization
Time frame: one year
Major and Minor Bleeding
Time frame: one year
Results and safety
The study was stopped early (reason given: Slower than anticipated recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: Yes. De-identified Data Sharing only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Kreutz, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescriber Access to Genetic Information in people with Coronary Artery Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slower than anticipated recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in prescription of antiplatelet therapy (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.