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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT02044250
Eligibility Criteria:
Inclusion Criteria:
1. Male and female aged ≥20 years
2. Maintenance of dual or triple antiplatelet therapy at least 12 ± 6 months after PCI with DES
3. No history of further clinical event after PCI with DES
4. Plan to change to antiplatelet monotherapy
5. Agreement to give written informed consent
Exclusion Criteria:
1. History of hypersensitivity to aspirin or clopidogrel
2. History of contraindication to aspirin or clopidogrel
3. Active pathologic bleeding, such as peptic ulcer, tumor bleeding or intracranial hemorrhage
4. History of major bleeding, BARC class ≥3, resulting in stop of antiplatelet agents within 3 months
5. Bleeding diathesis
6. Known coagulopathy or refusal of blood transfusion
7. Presence of non-cardiac comorbidity with life expectancy \<2 years from randomization
8. Plan to surgery or intervention which needs to stop antiplatelet agents ≥3 months
9. Females with childbearing potential or breast-feeding
10. Conditions that may result in protocol non-compliance by the committees
11. Co-administration of contraindicated medications as follows: other P2Y 12 inhibitors (prasugrel or ticagrelor); anticoagulants (warfarin, new oral anticoagulants, or chronic therapy of heparin); cytochrome P450 2C19 inhibitors (fluoxetine, moclobemid or voriconazole); probenecid; high dose of methotrexate (≥15 mg/week); lithium
12. Refusal to give written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02044250
Study Brief:
Protocol Section:
NCT02044250