A Randomized, Open-label, Investigator-initiated, Pilot Clinical Trial Comparing the Improvement for Ankle Brachial Index and Safety of Sarpogrelate and Clopidogrel in Stroke Patients Accompanying Lower Extremity Vascular Atherosclerosis With Decrease of Ankle Brachial Index and Intermittent Claudication.

SEUMC 2023-10-009

The clinical trial aims to confirm the improvement effect of the ankle brachial index and the safety of sarpogrelate administration compared to clopidogrel in stroke patients with decreased ankle brachial arterial pressure index and intermittent claudication of lower limb vascular atherosclerosis. Subjects are assigned to one of the two combinations through random allocation. Intervention group: Aspirin 100mg + sarpogrelate 300mg dosing group, Control group: Aspirin 100mg + clopidogrel 75mg dosing group. This clinical trial is a prospective open study and will be conducted in compliance with the usual diagnosis and treatment process, and in particular, all trial subjects will be tested and treated appropriately in accordance with the standard treatment guidelines for ischemic stroke during the clinical trial period.

2024-05-16

2028-06-30

2028-12-31

Not yet recruiting

100

Inclusion Criteria: 1. Aged 19 or over. 2. Neurologically stable patients after 7 days and within 6 months of diagnosis of ischemic stroke. 3. Patients with ankle-brachial index (ABI) \<0.9 performed within 6 months of screening, with lower limb vascular stenosis and intermittent claudication. 4. A person who voluntarily agrees to participate in this clinical trial in writing. Exclusion Criteria: 1. Patients who are unable or contraindicated to administer antithrombotic drugs. 2. Patients with less than 80,000 platelets, less than 8.0 hemoglobin, liver levels and total bilirubin levels three times normal according to laboratory standards, according to blood tests conducted within one month. 3. Patients identified as undergoing renal replacement therapy such as dialysis due to acute or terminal nephropathy during screening. 4. Patients diagnosed with or treated for cancer within 6 months of screening, or identified as having recurrent or metastatic cancer. 5. Patients confirmed to be on medication for liver diseases such as liver cirrhosis during screening. 6. A pregnant and lactating women. 7. Patients with a history of hemorrhagic tendency, conventional cerebral hemorrhage, and gastrointestinal hemorrhage. 8. Patients who need oral anticoagulant therapy instead of antiplatelet drugs for screening. 9. Patients who are at least 3 in the Rutherford category and need lower-limb vascular procedure/surgery within 6 months, as judged by the doctor. 10. A patient with a loss of consciousness/cognition. 11. Any person who determines that the tester is not suitable for participating in the clinical trial for other reasons.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-05-22