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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT02660866
Eligibility Criteria:
Pre-screening criteria
* Laboratory values available ≤ 1 year of the date of screening: hemoglobin ≥9g, platelet count \>50,000 mm3 or \<600,000 mm3
* No history of stroke or transient ischemic attack (TIA)
* No allergy to aspirin
* ≥40 years of age
* Presence of documented PAD by ABI \<0.80 at rest or ≥20% drop in claudication limited exercise ABI in any limb and one of the following criteria in the corresponding limb:
i.Prior surgical and/or endovascular lower extremity intervention (infra-renal aorta to pedal arteries) ii. Known presence of flow-limiting stenosis (≥70%) by clinically indicated angiography, computed tomographic (CT) or magnetic resonance imaging (MRI) tests or by Duplex ultrasonography (DUS) defined standard clinical criteria in lower extremity arteries
* Documented IC Rutherford/Becker (RC) category ≥2
* Presence of any one of the listed classes of agents \[angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), lipid lowering therapy, aspirin and beta-blocker drugs\]-No MI or percutaneous coronary intervention (PCI) with DES within the past 11 months
* No planned surgical or endovascular procedures other than for the treatment of IC for the expected duration of the study
* No warfarin or other chronic oral anticoagulant use within the last 14 days
* No use of ticagrelor, clopidogrel, prasugrel or ticlopidine within last 7 days
* No contraindication(s) to the use of antithrombin or antiplatelet agents (history of intra-cerebral hemorrhage or ICH, presence of intracerebral mass, recent or \<12 weeks gastrointestinal bleed requiring blood transfusion, any blood transfusion within the last 6 weeks, any trauma requiring surgery within the last 4 weeks or any surgical or endovascular procedure within the last 4 weeks
* No use of cilostazol and/or pentoxyphilline within last 7 days
* Severe psychiatric or behavioral illness that in the judgement of the investigator precludes study participation
* No history of major or minor amputation
* Severe heart, vascular and lung disease in the discretion of the investigator that precludes study participation.
* Ability to walk for at least 15 min/day, at least 3 days/week, at ≥20 steps/min
Inclusion criteria
* Treadmill PWT= 2-10 min on Gardner protocol
* Estimated survival ≥1 year in the judgment of the site investigator
* Use of at least one aspirin dose within at least 5 days prior to randomization at 325 mg dose in aspirin naïve patients (0-5 days of prior aspirin use) or at least one aspirin dose prior to randomization at 81 mg dose in patients on chronic (\>5 days) aspirin therapy (at clinically indicated doses).
* Presence of any one of the listed classes of agents \[angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), lipid lowering therapy, aspirin and beta-blocker drugs\]
Exclusion Criteria:
* MI or percutaneous coronary intervention (PCI) with DES within the past 11 months
* Positive pregnancy test
* Planned surgical or endovascular procedures other than for the treatment of IC
* Warfarin or other chronic oral anticoagulant use within 14 days
* Use of Ticagrelor, Clopidogrel, Prasugrel or Ticlopidine within 7 days
* Contraindication(s) to the use of antithrombin or antiplatelet agents (history of intra-cerebral hemorrhage or ICH, presence of intracerebral mass, recent or \<12 weeks gastrointestinal bleed requiring blood transfusion, any blood transfusion within the last 6 weeks, any trauma requiring surgery within the last 4 weeks or any surgical or endovascular procedure within the last 4 weeks
* Use of cilostazol and/or pentoxyphilline within 7 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT02660866
Study Brief:
Protocol Section:
NCT02660866