Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention

Description

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.

Conditions

Coronary Artery Disease

Study Overview

Study Details

Study overview

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.

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

Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention

Condition
Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Jacksonville

University of Florida Jacksonville, Jacksonville, Florida, United States, 32209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Stable CAD undergoing elective PCI;
  • 2. Male or females, Age ≥ 18 years old;
  • 3. Troponin negative before coronary angiography;
  • 4. On treatment with low-dose aspirin (81mg od) and clopidogrel for at least 24 hours after index PCI;
  • 5. ABCD-GENE score greater or equal than 10.
  • 1. Myocardial infarction at the time of index PCI;
  • 2. On treatment with prasugrel or ticagrelor;
  • 3. Documented hypersensitivity to clopidogrel;
  • 4. Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) in the prior 24 hours;
  • 5. Concomitant therapy with strong CYP3A4 inhibitors or CYP3A4 substrates;
  • 6. Use of oral anticoagulant therapy;
  • 7. History of previous intracerebral bleed at any time;
  • 8. Active pathological bleeding;
  • 9. Documented hypersensitivity to ticagrelor;
  • 10. Increased risk of bradycardic events (e.g., known sick sinus syndrome, second or third degree AV block or previous documented syncope suspected to be due to bradycardia) unless treated with a pacemaker;
  • 11. Known severe liver disease;
  • 12. Known platelet count \<80x106/mL;
  • 13. Known hemoglobin \<9 g/dL;
  • 14. Women of child-bearing potential (i.e., those who are not chemically or surgically sterilized or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR who have a positive pregnancy test at enrollment or randomization OR women who are breast-feeding.
  • 15. Inability to provide written informed consent.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Florida,

Francesco Franchi, MD, PRINCIPAL_INVESTIGATOR, Univesrsity of Florida

Study Record Dates

2026-02-28