RECRUITING

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

Conditions

Coronary Artery Disease platelet reactivity antiplatelet therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-01

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06228456

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Francesco Franchi, MD

CONTACT

9042442060

francesco.franchi@jax.ufl.edu

Andrea Burton, MPH, CPH

CONTACT

9042445617

andrea.burton@jax.ufl.edu

Principal Investigator

Francesco Franchi, MD

PRINCIPAL_INVESTIGATOR

Univesrsity of Florida

Study Locations (Sites)

University of Florida Jacksonville

Jacksonville, Florida, 32209

United States

Collaborators and Investigators

Sponsor: University of Florida

Francesco Franchi, MD, PRINCIPAL_INVESTIGATOR, Univesrsity of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2024-04-01

Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

platelet reactivity
antiplatelet therapy

Additional Relevant MeSH Terms

Coronary Artery Disease