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 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
NCT ID:
NCT02325466
Eligibility Criteria:
Inclusion Criteria:
* Female or male aged ≥ 35 years
* Type 2 diabetes mellitus
* Symptomatic PAD
* Ankle-brachial index ≤ 0.85 or calcified blood vessels with toe-brachial index ≤ 0.6 and/or abnormal post-exercise ankle-brachial index
* Prior surgical or percutaneous intervention of the peripheral arteries ≥12 months previously with a residual stenoses of ≥50% in a non-dilated artery.
Exclusion Criteria:
* Subject is pregnant or breast-feeding
* Planned revascularization or amputation
* Known bleeding disorder
* History of intracranial hemorrhag3
* Considered at risk of hemorrhagic events
* Hypersensitivity or allergic reactions to aspirin
* Concomitant use of anticoagulants such as warfarin, dabigatran, factor Xa inhibitors or antiplatelet drugs such as clopidogrel, dipyridamole and sulfapyridine
* Subject has a condition or circumstance which would prevent them from adhering to treatment regimens
* Subject has active infection
* Subject has an anemia
* Subject has given blood or received a blood transfusion at any point during the study
* Subject has polycythemia vera or any hyperviscosity syndrome
* Subjects with Waldenstrom's macroglobulinemia who have an increased risk of hyperviscosity syndrome
* Subject has history of severe liver disease, obstructive liver disease such as primary biliary cirrhosis or end-stage renal disease (eGFR \<30 mL/min/m2)
* Family members or employees of the investigator or study centers involved in the study
* Subject has poor diabetes or hypertension control (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02325466
Study Brief:
Protocol Section:
NCT02325466