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:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT02545933
Eligibility Criteria:
Inclusion criteria:
1. Patients with a prior MI within the previous 2 weeks to 12 months.
2. On DAPT with low-dose aspirin (81mg od) and either prasugrel (10mg od) or ticagrelor (90mg bid) as per standard-of-care for at least 2 weeks.
3. Free from bleeding and ischemic events after the index MI event.
4. Age between 18 and 75 years old.
Exclusion criteria:
1. History of stroke, transient ischemic attack, or intracranial hemorrhage.
2. Active pathological bleeding, history of bleeding events or increased risk of bleeding.
3. Known severe hepatic impairment.
4. Age \>75 years.
5. Body weight \<60 Kg.
6. Use of strong Cytochrome P450 3A 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).
7. On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban).
8. On treatment with any antiplatelet agent other than aspirin, prasugrel and ticagrelor in the past 14 days.
9. Creatinine clearance \<30 mL/minute.
10. Platelet count \<80x106/mL
11. Hemoglobin \<10g/dL
12. Hemodynamic instability
13. Pregnant females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02545933
Study Brief:
Protocol Section:
NCT02545933