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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT01118793
Eligibility Criteria:
Inclusion Criteria:
* Males and non-pregnant females between the ages of 18-85.
* Patients able to give informed written consent.
* Patients on clopidogrel for ≥ 7 days.
Exclusion Criteria:
* Participation in a study of experimental therapy or device within prior 30 days.
* Pregnant women or women of childbearing potential not using an acceptable method of contraception who have not been proven to have a negative pregnancy test result.
* Inability to comply with all aspects of the protocol.
* History of bleeding diathesis or evidence of active abnormal bleeding within previous 90 days.
* Severe hypertension (systolic blood pressure \> 200 mm Hg or diastolic blood pressure \> 110 mm Hg) not adequately controlled on antihypertensive therapy.
* Major surgery within the preceding 6 weeks.
* History of stroke within 30 days or any history of hemorrhagic stroke.
* History of intracranial neoplasm.
* Current or planned administration of another parenteral GP IIb-IIIa inhibitor within 7 days of enrollment.
* Known hypersensitivity to any component of the product.
* Unstable angina with dynamic ST or T wave changes within 48 hours of enrollment.
* Administration of LMWH within 8 hours prior to enrollment or UFH within 60 minutes unless a PPT \< 50 secs or ACT \< 150 secs.
* On chronic anticoagulation (i.e. Coumadin).
* Hemoglobin \< 10 g/dL.
* Hematocrit \< 30%.
* Platelet count \< 100,000 mcL.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01118793
Study Brief:
Protocol Section:
NCT01118793