RecruitingPhase 4NCT06228456

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

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

Sponsor

University of Florida

Enrollment

50 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease

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

Min Age: 18 Years

Inclusion Criteria6

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.
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 Criteria15

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;
Documented hypersensitivity to ticagrelor;
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;
Known severe liver disease;
Known platelet count <80x106/mL;
Known hemoglobin <9 g/dL;
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.
Inability to provide written informed consent.

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Interventions

DRUGTicagrelor 60mg

Patients in the ticagrelor arm will receive a 180 mg loading dose of ticagrelor followed by ticagrelor 60 mg bid maintenance dose for 30±5 days. Patients will maintain aspirin 81 mg once daily for the duration of the study.

DRUGClopidogrel

Patients in the clopidogrel arm will continue to receive clopidogrel 75 mg/daily for 30±5 days. Patients will maintain aspirin 81 mg once daily for the duration of the study.