Pharmacodynamic Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention Who Are At Risk of Peri-PCI Myocardial Infarction Using a Precision Medicine Tool

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The proposed study aims to assess the antiplatelet effects of more potent oral P2Y12 inhibition with low-dose ticagrelor (60 mg bid) compared with standard of care clopidogrel in patients with a high ABCD-GENE score (≥10). We hypothesize that ticagrelor is associated with better pharmacodynamic effects (i.e., lower platelet reactivity and high platelet reactivity rates) compared with clopidogrel in stable coronary artery disease patients undergoing percutaneous coronary intervention with a high ABCD-GENE score.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Stable CAD undergoing elective PCI;

• Male or females, Age ≥ 18 years old;

• Troponin negative before coronary angiography;

• On treatment with low-dose aspirin (81mg od) and clopidogrel for at least 24 hours after index PCI;

• ABCD-GENE score greater or equal than 10.

⁃ Troponin negative is defined as hs-cTn below the URL for the laboratory (Male \< 22 ng/L; Female \< 14 ng/L) or modestly positive hs-cTn (Male: 22-99 ng/L; Female: 14-99 ng/L) flat or decreasing from hour 0 to 3.

Locations
United States
Florida
University of Florida Jacksonville
RECRUITING
Jacksonville
Contact Information
Primary
Francesco Franchi, MD
francesco.franchi@jax.ufl.edu
9042442060
Backup
Andrea Burton, MPH, CPH
andrea.burton@jax.ufl.edu
9042445617
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 50
Treatments
Experimental: Low-dose ticagrelor
Stable CAD patients undergoing elective PCI treated with standard of care clopidogrel will be randomly assigned in a 1:1 fashion to either switch to ticagrelor or continue with clopidogrel.
Active_comparator: Clopidogrel
Stable CAD patients undergoing elective PCI treated with standard of care clopidogrel will be randomly assigned in a 1:1 fashion to either switch to ticagrelor or continue with clopidogrel.
Sponsors
Collaborators: Scott R. MacKenzie Foundation
Leads: University of Florida

This content was sourced from clinicaltrials.gov

Similar Clinical Trials