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

Trial Information

Current as of October 03, 2024

Recruiting

Keywords

Platelet Reactivity Antiplatelet Therapy

Description

Clopidogrel is the P2Y12 inhibitor of choice in patients with stable coronary artery disease (CAD) undergoing elective percutaneous coronary intervention (PCI). However, clopidogrel effects are subject to variability and 30-40% of patients have high platelet reactivity (HPR), which translates into higher rates of thrombotic complications. Despite the relative safety of PCI with new generation stents, peri-PCI thrombotic complications, including myocardial infarction and myocardial injury, are common in elective PCI. Importantly, these events are associated with poor prognosis, including car...

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.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Jacksonville, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0