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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT06886620
Eligibility Criteria:
Main Inclusion Criteria:
* Stable use of Cilostazol of any strength and any dosing frequency for at least 3 months prior to screening, for the treatment of peripheral arterial disease.
* Initial claudication distance ≥ 30 meters at the constant workload treadmill test.
Main Exclusion Criteria:
* Presence of limb-threatening chronic limb ischemia, manifested by ischemic rest pain, ulceration or gangrene.
* History of lower-extremity surgical or endovascular arterial reconstructions or sympathectomy within 3 months prior to screening.
* Presence of illness(es) (such as angina pectoris, respiratory disease, orthopaedic disease, or neurological disorders, except the study disease) limiting the exercise capacity.
* Presence of uncontrolled hypertension (based on physician's judgment) or other unstable cardiovascular disease such as congestive heart failure of any severity and myocardial infarction within 6 months prior to screening.
* History of coronary artery bypass graft (CABG) or major cardiovascular surgical procedures within 6 months prior to screening.
* History of Buerger's disease or deep vein thrombosis within 3 months prior to screening.
* Presence of haemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer and intracranial bleeding.
* Presence or history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular tachycardia with or without adequate treatment, QTc prolongation associated with cardiac disorders, or severe tachyarrhythmia within 6 months prior to screening, which is considered not suitable for this study by Investigator.
* History of type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
* Use of anticoagulant agent(s) within 6 months prior to screening.
* Use of two or more than two anti-platelet agents within 3 months prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT06886620
Study Brief:
Protocol Section:
NCT06886620