Clinical Trials Logo

Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04090281
Study type Interventional
Source University of Southern California
Contact
Status Active, not recruiting
Phase Phase 4
Start date March 13, 2020
Completion date November 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04951856 - Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI Phase 4
Completed NCT03103620 - Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
Completed NCT04648306 - Restore EF Observational Study
Recruiting NCT06095557 - MCG Discovery Study in Emergency Departments N/A
Not yet recruiting NCT04403048 - Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID N/A
Completed NCT03489603 - Clinical and Economic Outcomes of High Sensitivity Troponin for no ST Elevation Myocardial Infarction in Patients With Chest Pain in Emergency Departments in Italy-An Observational Study
Recruiting NCT04140019 - Early Cardiac Magnetic Resonance Imaging in Suspected Non-ST-Elevation Myocardial Infarction
Completed NCT04289012 - HELicobacter Pylori Screening in Patients With Acute Myocardial Infarction Pilot Study N/A
Active, not recruiting NCT03052036 - The British Heart Foundation SENIOR-RITA Trial N/A
Completed NCT02983123 - One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome
Completed NCT03943966 - In-vivo Thrombus Imaging With 18F-GP1, a Novel Platelet PET Radiotracer N/A
Completed NCT03677180 - National Cardiogenic Shock Initiative
Completed NCT03507777 - ILUMIEN IV: OPTIMAL PCI N/A
Recruiting NCT03863327 - EKG Criteria and Identification of Acute Coronary Occlusion
Completed NCT03461484 - e-BioMatrix 6 Month DAPT France
Recruiting NCT03089450 - To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent N/A
Recruiting NCT03562572 - FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease N/A
Completed NCT03822377 - Ticagrelor Administered as Standard Tablet or Orodispersible Formulation Phase 3
Recruiting NCT04002739 - PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome N/A
Completed NCT03111862 - Safety of Accelerated Rule-out Protocols in Patients Admitted With Chest Pain to a Crowded Chest Pain Unit (CPU)