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:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
NCT ID:
NCT01765400
Eligibility Criteria:
Inclusion Criteria:
* Patients 19 to 74 years of age.
* Patients with a left ventricular ejection fraction \<35% by echocardiogram, SPECT myocardial perfusion study, cardiac MRI, cardiac computerized tomographic angiogram or invasive left ventricular angiogram within the last 6 months.
* Patients with NYHA Class III-IV heart failure at the time of enrollment.
Exclusion Criteria:
* Recent hospitalization within 30 days
* Patients expected to undergo major surgery or PCI in the next 30 days
* Patients taking clopidogrel, prasugrel, ticagrelor, ticlopidine, or cilostazol
* Patients listed for heart transplantation or having left ventricular assist device placement
* Patients with known allergy to either medication
* Patients with prior history of stroke or transient ischemic attack
* Patients with known intracranial neoplasm, aneurysm, or arteriovenous malformation
* Patients with a history of bleeding requiring hospitalization for treatment
* Patients taking oral anticoagulants
* Patients with body weight \<60 kg
* Women who are pregnant or breastfeeding
* Patients with hemoglobin \<10 mg/dl or platelet count \<100,000/ul at baseline
* Patients with known clotting or platelet disorders
* Patients with a baseline INR \> 1.4
* Patients with liver function tests (AST or ALT) \> 2 times normal
* Patients with a suspected change in their use of aspirin during the study (starting, stopping, or changing dose of aspirin)
* Patients unwilling to consent to CYP2C19 genetic testing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT01765400
Study Brief:
Protocol Section:
NCT01765400