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 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT02567461
Eligibility Criteria:
Inclusion criteria:
1. Patients with angiographically documented CAD (previous PCI or ACS).
2. On DAPT with low-dose aspirin (81mg od) and clopidogrel for at least 30 days as per standard-of-care.
3. Age above 18.
Exclusion criteria:
1. Active pathological bleeding, history of clinically significant bleeding events, or deemed at increased risk of bleeding.
2. CrCL \<15mL/min
3. Any clinical indication to be on anticoagulant therapy
4. Acute coronary events in the past 90 days
5. Prior hemorrhagic stroke or intracranial hemorrhage
6. Ischemic stroke/transient ischemic attack in the past 6 months
7. Chronic use of nonsteroidal anti-inflammatory drugs
8. On treatment with rifampin (induce or P-gp transporter)
9. Known moderate or severe hepatic impairment (Child-Pugh B and C).
10. On treatment with any antiplatelet agent other than aspirin and clopidogrel in the past 30 days.
11. Platelet count \<80x106/mL
12. Hemoglobin \<10g/dL
13. Hemodynamic instability
14. Pregnant females \[women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study\].
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02567461
Study Brief:
Protocol Section:
NCT02567461