RecruitingPhase 4

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

United States50 participantsStarted 2024-04-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Myocardial infarction at the time of index PCI;
✕. On treatment with prasugrel or ticagrelor;
✕. Documented hypersensitivity to clopidogrel;
✕. Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) in the prior 24 hours;
✕. Concomitant therapy with strong CYP3A4 inhibitors or CYP3A4 substrates;
✕. Use of oral anticoagulant therapy;
✕. History of previous intracerebral bleed at any time;
✕. Active pathological bleeding;

What they're measuring

P2Y12 reaction units (PRU)

Timeframe: 30 days

Trial details

NCT IDNCT06228456

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Francesco Franchi, MD

9042442060 francesco.franchi@jax.ufl.edu

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