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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT03384966
Eligibility Criteria:
Main Inclusion Criteria:
1. Signed informed consent prior to any study-mandated procedure.
2. Male and female subjects aged from 18-85 years, inclusive.
3. For women of childbearing potential: Negative urine pregnancy test at Visit 1 and at Visit 2 before randomization.
4. Stable Coronary artery disease (CAD) defined by the presence of any of the following conditions:
1. History of CAD with coronary artery stenosis on coronary angiogram ≥50%.
2. Previously documented myocardial infarction occurring more than 3 months prior to randomization.
5. Antiplatelet background therapy stable for at least 1 month prior to randomization.
6. Body weight ≥ 40.0 kg (88.2 lbs).
Main Exclusion Criteria:
1. Acute coronary syndrome, percutaneous coronary intervention or any intervention for peripheral artery disease within 3 months prior to randomization.
2. Acute ischemic stroke or transient ischemic attack (TIA) within 3 months prior to randomization.
3. Active internal bleeding, or medical history of recent (\< 1 month) bleeding disorders or conditions associated with high risk of bleeding (e.g., clotting disturbances, gastrointestinal bleed, hemoptysis).
4. Hemoglobin ≤ 10 g/dL at screening.
5. Loss of at least 250 mL of blood within 3 months of screening.
6. Use of anticoagulants (oral, parenteral) or fibrinolytic therapy within 24 h prior to screening (Visit 1).
7. Known platelet disorders (e.g., thrombasthenia, thrombocytopenia, von Willebrand disease).
8. Pregnant or breastfeeding women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03384966
Study Brief:
Protocol Section:
NCT03384966