Search / Trial NCT06228456

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

Launched by UNIVERSITY OF FLORIDA · Jan 19, 2024

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Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Platelet Reactivity Antiplatelet Therapy

ClinConnect Summary

This clinical trial is studying the effects of a medication called ticagrelor, taken in a lower dose, compared to clopidogrel, which is a standard medication used to prevent blood clots. The trial focuses on patients with stable coronary artery disease who are undergoing a specific heart procedure known as elective percutaneous coronary intervention (PCI). Researchers believe that ticagrelor may work better in reducing the activity of platelets (the cells that help blood clot) in patients who have a high ABCD-GENE score, which indicates a higher risk for heart issues.

To participate in the trial, individuals must be at least 18 years old, have stable coronary artery disease, and show no signs of a heart attack before the procedure. They should also be receiving low-dose aspirin and clopidogrel for a short time before the study begins. Participants can expect to be closely monitored during the trial to assess how well the ticagrelor is working compared to clopidogrel. It's important to note that certain health conditions or treatments may prevent someone from joining the trial, such as recent heart attacks, severe bleeding, or being on other specific medications. If you're interested in learning more or think you might qualify, it's a good idea to discuss this with your healthcare provider.

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

Francesco Franchi, MD

Principal Investigator

Univesrsity of Florida

About University Of Florida

The University of Florida, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials. With a focus on enhancing patient outcomes and exploring new therapeutic avenues, the university leverages its extensive resources, interdisciplinary expertise, and state-of-the-art facilities to conduct rigorous research across a variety of medical fields. Committed to ethical standards and patient safety, the University of Florida fosters collaboration among researchers, healthcare professionals, and community stakeholders to translate scientific discoveries into impactful clinical applications.

Locations

Jacksonville, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0