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NCT06228456RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 5 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
50 (estimated)
First submitted
19 Jan 2024
Start date
1 Apr 2024
Primary completion date
31 Dec 2026
Lead sponsor
University of Florida
NCT number
NCT06228456

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 50
  • From 1 Apr 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • On treatment with prasugrel or ticagrelor;
  • 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;
  • 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;

Other illness

  • Myocardial infarction at the time of index PCI;
  • Documented hypersensitivity to clopidogrel;
  • Active pathological bleeding;
  • Documented hypersensitivity to ticagrelor;
  • Known severe liver disease;

Lab values

  • Known platelet count \<80x106/mL;
  • Known hemoglobin \<9 g/dL;

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Florida - Jacksonville
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.