Comparison of the Improvement and Safety of the Ankle Brachial Arterial Pressure Index of Sarpogrelate and Clopidogrel in Stroke Patients With Decreased Ankle Brachial Arterial Pressure Index and Intermittent Claudication of Lower Limb Vascular Atherosclerosis.

Launched by EWHA WOMANS UNIVERSITY SEOUL HOSPITAL · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective and safe a medication called sarpogrelate is compared to clopidogrel for patients who have had a stroke and experience leg pain due to poor blood flow. The researchers want to see if using sarpogrelate can improve a specific measure of blood flow called the ankle-brachial index (ABI) in these patients. This trial will involve participants taking either aspirin and sarpogrelate or aspirin and clopidogrel, and it will follow standard treatment guidelines for stroke care.

To be eligible for this trial, participants need to be at least 19 years old and have stable health after a stroke that occurred within the last 6 months. They should also have a low ABI (below 0.9) indicating reduced blood flow in the legs. However, people who have certain health issues, like severe kidney disease or a history of bleeding problems, cannot participate. If someone joins the trial, they can expect regular check-ups and care in line with typical stroke treatment while they are part of the study.

Gender

ALL

Eligibility criteria

• 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.