NCT06228456 · University of Florida
Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention
What this study is about
The proposed study aims to assess the antiplatelet effects of more potent taken by mouth P2Y12 inhibition with low-dose ticagrelor (60 mg bid) compared with the usual treatment clopidogrel in patients with a high ABCD-GENE score (≥10). We hypothesize that ticagrelor is associated with better how the drug affects the body effects (i.e.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. 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
- 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.
Where
- Jacksonville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations