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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT02548650
Eligibility Criteria:
Inclusion criteria:
1. Patients with a prior MI between 2 weeks and 24 months or with PAD.
2. On DAPT with low-dose aspirin (81mg od) and clopidogrel (75mg od) as per standard-of-care for at least 14 days.
3. Age ≥ 18 years old.
Exclusion criteria:
1. History of acute coronary syndrome in the previous 2 weeks.
2. History of stroke, transient ischemic attack, or intracranial hemorrhage.
3. Active pathological bleeding, history of bleeding events or increased risk of bleeding.
4. Known severe hepatic impairment.
5. Use of strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) or inducers (e.g., rifampin, carbamazepine, St. John's Wort and phenytoin).
6. On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban).
7. On treatment with any antiplatelet agent other than aspirin and clopidogrel in the past 14 days.
8. Creatinine clearance \<30 mL/minute.
9. Platelet count \<80x106/mL
10. Hemoglobin \<10g/dL
11. Hemodynamic instability
12. Pregnant females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02548650
Study Brief:
Protocol Section:
NCT02548650