Recruiting

Ticagrelor vs. Clopidogrel

Sponsor:

University of Florida

Code:

NCT06228456

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ticagrelor 60mg

Clopidogrel

Study Details

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.

Conditions

Coronary Artery Disease

Study ID

NCT06228456

Start date

Apr 1, 2024

Status verified date

Feb, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low-dose ticagrelor

Stable CAD patients undergoing elective PCI treated with standard of care clopidogrel will be randomly assigned in a 1:1 fashion to either switch to ticagrelor or continue with clopidogrel.

active comparator: Clopidogrel

Stable CAD patients undergoing elective PCI treated with standard of care clopidogrel will be randomly assigned in a 1:1 fashion to either switch to ticagrelor or continue with clopidogrel.

Interventions

Ticagrelor 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.

Clopidogrel

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.

Primary outcome measure

  • P2Y12 reaction units (PRU) [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

University of Florida Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

More Information

Sponsor

University of Florida

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • platelet reactivity
  • antiplatelet therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-02-05.