Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT06228456
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06228456
Study Brief:
Protocol Section:
NCT06228456