Ignite Creation Date:
2024-05-06 @ 1:42 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04090281
Status:
UNKNOWN
Last Update Posted:
2021-09-28
First Post:
2019-09-06
Brief Title:
Implementing Precision Medicine Approaches to Guide Anti-platelet Selection
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Implementing Precision Medicine Approaches to Guide Anti-platelet Selection Following Percutaneous Coronary Intervention PCI
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None