Comparing low-dose ticagrelor and clopidogrel in heart patients undergoing procedures

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

This study is testing if a lower dose of ticagrelor can help heart patients with high platelet activity have fewer complications during and after a procedure compared to clopidogrel.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT06228456 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of low-dose ticagrelor compared to clopidogrel in patients with stable coronary artery disease who are undergoing elective percutaneous coronary intervention. It focuses on patients identified as having high platelet reactivity using the ABCD-GENE score, which combines clinical and genetic factors. The goal is to determine if ticagrelor can reduce the risk of thrombotic complications associated with the procedure. Participants will be monitored for their platelet reactivity and overall outcomes following treatment.

Who should consider this trial

Good fit: Ideal candidates are stable coronary artery disease patients aged 18 and older with a high ABCD-GENE score undergoing elective PCI.

Not a fit: Patients currently experiencing a myocardial infarction or those on other antiplatelet therapies like prasugrel or ticagrelor will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved antiplatelet therapy for patients at risk of complications during heart procedures.

How similar studies have performed: Previous studies have shown that more potent P2Y12 inhibitors like ticagrelor can reduce high platelet reactivity and improve outcomes, suggesting a promising approach.

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.

Where this trial is running

Jacksonville, Florida

• University of Florida Jacksonville — Jacksonville, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Francesco Franchi, MD — Univesrsity of Florida
• Study coordinator: Francesco Franchi, MD

Conditions Coronary Artery Disease; platelet reactivity; antiplatelet therapy