Acute Coronary Syndrome (ACS)Phase 4NCT04090281
Implementing Precision Medicine Approaches to Guide Anti-platelet Selection
A Phase 4 study testing CYP2C19 genotyping in people with Acute Coronary Syndrome (ACS) and STEMI - ST Elevation Myocardial Infarction (MI), run by University of Southern California at 1 site in United States.
Trial summary
The study aims to determine the feasibility and clinical utility of incorporating precision medicine approaches, incorporating both cytochrome P450 2C19 (CYP2C19) genotyping and platelet reactivity phenotyping, with standard of care for patients with acute coronary syndromes (ACS), post PCI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome (ACS), STEMI - ST Elevation Myocardial Infarction (MI), NSTEMI - Non-ST Segment Elevation MI
- What is being tested?
- CYP2C19 genotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2020to 30 Nov 2023
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with troponin positive ACS
- Patients scheduled for left heart catheterization and undergoing PCI
- Age 18-80 years at time of enrollment
- Currently receiving or anticipated to receive DAPT, with P2Y12 inhibitor
- Ability to follow-up for a clinic visit with LAC+USC outpatient cardiology
- Written informed consent
Who cannot join
- Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage
- Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage, and a history of prior transient ischemic attack (TIA) or stroke
- Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to enrolling in this study. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i. v. catecholamines) for ≥7 days.
- Subjects requiring concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban)
- Indication for major surgery (per decision of the treating physician) for the planned duration of the study
- Subject with history of liver transplant or plan to undergo liver transplant during the next 12 months
- Evidence of significant active neuropsychiatric disease, in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC+USC Medical Center
Los Angeles, California, 90033
About this study
Official title: Implementing Precision Medicine Approaches to Guide Anti-platelet Selection Following Percutaneous Coronary Intervention (PCI)
The study aims to determine the feasibility and clinical utility of incorporating precision medicine approaches, incorporating both cytochrome P450 2C19 (CYP2C19) genotyping and platelet reactivity phenotyping, with standard of care for patients with acute coronary syndromes (ACS), post PCI.
Read the detailed description
Study Population:
Adult patients will be eligible for inclusion if they provide informed consent and have no contraindications for 12-months of dual antiplatelet therapy (DAPT).
Baseline Evaluation:
Overview of clinical protocol: Patients with successful PCI will receive a genotype guided recommendation, upon discharge, based on CYP2C19 genotype. Patients who are determined to have CYP2C19 poor metabolizer (PM) or intermediate metabolizer (IM) status will be recommended to receive 12-months of prasugrel. Patients who are determined to have CYP2C19 normal metabolizer (NM), rapid metabolizer (RM), or ultra-rapid metabolizer (UM) phenotype will be recommended to receive a de-escalation treatment, guided by on-treatment platelet reactivity phenotype at 14 days, post discharge.
30-day, 6-month, and 12-month Follow-up: Patients will be contacted by phone or visited during one of their regularly scheduled appointments, at 14 days, 30 days, 6 months , and 12 months, to complete "Follow-up Case Report Forms" to collect outcomes data. The 12-month follow up communication with enrolled patients will end their participation in the study.
- Conditions
- Acute Coronary Syndrome (ACS), STEMI - ST Elevation Myocardial Infarction (MI), NSTEMI - Non-ST Segment Elevation MI, Unstable Angina (UA)
- Being tested
- CYP2C19 genotyping
- Keywords
- precision medicine, antiplatelet, pharmacogenetics, de-escalation, dual antiplatelet therapy (DAPT), percutaneous coronary intervention (PCI)
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP2C19 genotypingGenetic
Also called platelet reactivity phenotyping
Upon hospital discharge, patients will undergo CYP2C19 genotyping to guide initial P2Y12 inhibitor selection. At 14 days, post discharge, patients will undergo on treatment platelet reactivity phenotyping to further guide deescalation of P2Y12 inhibitor therapy
| Study group | Role | What they receive |
|---|---|---|
| Precision medicine implementation | Other | Patients will receive a precision medicine approach, incorporating both CYP2C19 genotyping and platelet reactivity phenotyping, to guide dual antiplatelet therapy selection for patients with ACS, post PCI and followed over a 12 month period. Receives: Genetic: CYP2C19 genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing pharmacogenetics to guide antiplatelet therapy
The proportion of patients in whom a genetic-guided recommendation is accepted by the clinician
Measured: 12 months
Feasibility of implementing platelet reactivity testing to guide de-escalation of antiplatelet therapy
The proportion of patients in whom a platelet reactivity phenotype-guided recommendation is accepted by the clinician
Measured: 12 months
Secondary outcomes (8)
Net clinical utility
The incidence of combined endpoints of major adverse cardiovascular events (MACE), stent thrombosis, unstable angina, major and minor bleeding, all-cause mortality, and hospital readmission rate within 30 days, post discharge
Measured: 30 days
Net clinical utility
The incidence of combined endpoints of MACE, stent thrombosis, unstable angina, major and minor bleeding, all-cause mortality, and hospital readmission rate within 12 months, post discharge
Measured: 12 months
Change in score of anxiety using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Patient Reported Outcomes Measurement Information System (PROMIS) subscale for anxiety include fear, anxiety, worry, and uneasiness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.
Measured: 30 days
Change in score of anxiety using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Patient Reported Outcomes Measurement Information System (PROMIS) subscale for anxiety include fear, anxiety, worry, and uneasiness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.
Measured: 12 months
Change in score of depression using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Patient Reported Outcomes Measurement Information System (PROMIS) subscale for depression include worthless, helpless, depressed, and hopelessness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.
Measured: 30 days
Change in score of depression using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Patient Reported Outcomes Measurement Information System (PROMIS) subscale for depression include worthless, helpless, depressed, and hopelessness. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.
Measured: 12 months
Change in score of social abilities using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Patient Reported Outcomes Measurement Information System (PROMIS) subscale for social abilities include leisure, family, usual work, and friends. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.
Measured: 30 days
Change in score of social abilities using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Patient Reported Outcomes Measurement Information System (PROMIS) subscale for social abilities include leisure, family, usual work, and friends. A score of 0 to 20 based on survey responses will be resulted for this subscale, with higher values representing a worse outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start13 Mar 2020
- Primary completion31 May 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-center, single arm, pragmatic study to determine feasibility of intervention
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Mosley, PharmD, University of Southern California
- Investigators
- Scott A Mosley, PharmD, Principal investigator, University of Southern California School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090281
- Sponsor's protocol ID
- APP-19-00099
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Precision Medicine Approaches to Guide Anti-platelet Selection Following Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT04090281
- Acronym / sponsor ID
- APP-19-00099
- Conditions
- Acute Coronary Syndrome (ACS), STEMI - ST Elevation Myocardial Infarction (MI), NSTEMI - Non-ST Segment Elevation MI, Unstable Angina (UA)
- Keywords
- precision medicine, antiplatelet, pharmacogenetics, de-escalation, dual antiplatelet therapy (DAPT), percutaneous coronary intervention (PCI)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 16 Sep 2019 (actual)
- 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.
The study aims to determine the feasibility and clinical utility of incorporating precision medicine approaches, incorporating both cytochrome P450 2C19 (CYP2C19) genotyping and platelet reactivity phenotyping, with standard of care for patients with acute coronary syndromes (ACS), post PCI.
Detailed description
Study Population:
Adult patients will be eligible for inclusion if they provide informed consent and have no contraindications for 12-months of dual antiplatelet therapy (DAPT).
Baseline Evaluation:
Overview of clinical protocol: Patients with successful PCI will receive a genotype guided recommendation, upon discharge, based on CYP2C19 genotype. Patients who are determined to have CYP2C19 poor metabolizer (PM) or intermediate metabolizer (IM) status will be recommended to receive 12-months of prasugrel. Patients who are determined to have CYP2C19 normal metabolizer (NM), rapid metabolizer (RM), or ultra-rapid metabolizer (UM) phenotype will be recommended to receive a de-escalation treatment, guided by on-treatment platelet reactivity phenotype at 14 days, post discharge.
30-day, 6-month, and 12-month Follow-up: Patients will be contacted by phone or visited during one of their regularly scheduled appointments, at 14 days, 30 days, 6 months , and 12 months, to complete "Follow-up Case Report Forms" to collect outcomes data. The 12-month follow up communication with enrolled patients will end their participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, single arm, pragmatic study to determine feasibility of intervention
| Arm | Type | Receives |
|---|---|---|
| Precision medicine implementation | Other | Genetic: CYP2C19 genotypingPatients will receive a precision medicine approach, incorporating both CYP2C19 genotyping and platelet reactivity phenotyping, to guide dual antiplatelet therapy selection for patients with ACS, post PCI and followed over a 12 month period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with troponin positive ACS
- Patients scheduled for left heart catheterization and undergoing PCI
- Age 18-80 years at time of enrollment
- Currently receiving or anticipated to receive DAPT, with P2Y12 inhibitor
- Ability to follow-up for a clinic visit with LAC+USC outpatient cardiology
Key exclusion criteria (7 listed)
- Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage
- Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage, and a history of prior transient ischemic attack (TIA) or stroke
- Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to enrolling in this study. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i. v. catecholamines) for ≥7 days.
- Subjects requiring concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban)
- Indication for major surgery (per decision of the treating physician) for the planned duration of the study
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 |
|---|---|---|
| CYP2C19 genotypingAlso: platelet reactivity phenotypingUpon hospital discharge, patients will undergo CYP2C19 genotyping to guide initial P2Y12 inhibitor selection. At 14 days, post discharge, patients will undergo on treatment platelet reactivity phenotyping to further guide deescalation of P2Y12 inhibitor therapy | Genetic | Precision medicine implementation |
Primary outcome
Feasibility of implementing pharmacogenetics to guide antiplatelet therapy
Time frame: 12 months
The proportion of patients in whom a genetic-guided recommendation is accepted by the clinician
Feasibility of implementing platelet reactivity testing to guide de-escalation of antiplatelet therapy
Time frame: 12 months
The proportion of patients in whom a platelet reactivity phenotype-guided recommendation is accepted by the clinician
8 secondary outcomes
Net clinical utility
Time frame: 30 days
Net clinical utility
Time frame: 12 months
Change in score of anxiety using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Time frame: 30 days
Change in score of anxiety using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Time frame: 12 months
Change in score of depression using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Time frame: 30 days
Change in score of depression using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Time frame: 12 months
Change in score of social abilities using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Time frame: 30 days
Change in score of social abilities using (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Yes
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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.
Scott A Mosley, PharmD principal investigator
University of Southern California School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CYP2C19 genotyping in people with Acute Coronary Syndrome (ACS) and STEMI - ST Elevation Myocardial Infarction (MI), run by University of Southern California 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Feasibility of implementing pharmacogenetics to guide antiplatelet therapy (time frame: 12 months). The study lists 2 primary outcomes in all. 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 Sep 2021.