NCT06228456 Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention
| NCT ID | NCT06228456 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Florida |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2024-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion 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. 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. Exclusion Criteria: 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.
Contact & Investigator
Francesco Franchi, MD
PRINCIPAL INVESTIGATOR
Univesrsity of Florida
Frequently Asked Questions
Who can join the NCT06228456 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06228456 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06228456 currently recruiting?
Yes, NCT06228456 is actively recruiting participants. Contact the research team at francesco.franchi@jax.ufl.edu for enrollment information.
Where is the NCT06228456 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT06228456 clinical trial?
NCT06228456 is sponsored by University of Florida. The principal investigator is Francesco Franchi, MD at Univesrsity of Florida. The trial plans to enroll 50 participants.