NCT06424548Not yet recruiting
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.
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.
Source: ClinicalTrials.gov · Last updated 22 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 15 Apr 2024
- Start date
- 16 May 2024
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Ewha Womans University Seoul Hospital
- Diseases
- Stroke
- NCT number
- NCT06424548
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 16 May 2024 to the primary completion date, 30 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are unable or contraindicated to administer antithrombotic drugs.
- Patients identified as undergoing renal replacement therapy such as dialysis due to acute or terminal nephropathy during screening.
- Patients who need oral anticoagulant therapy instead of antiplatelet drugs for screening.
- 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.
Other illness
- Patients diagnosed with or treated for cancer within 6 months of screening, or identified as having recurrent or metastatic cancer.
- Patients confirmed to be on medication for liver diseases such as liver cirrhosis during screening.
- Patients with a history of hemorrhagic tendency, conventional cerebral hemorrhage, and gastrointestinal hemorrhage.
Lab values
- 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.
Other
- A pregnant and lactating women.
- A patient with a loss of consciousness/cognition.
- Any person who determines that the tester is not suitable for participating in the clinical trial for other reasons.
Who the study is looking for
- Aged 19 or over.
- Neurologically stable patients after 7 days and within 6 months of diagnosis of ischemic stroke.
- Patients with ankle-brachial index (ABI) \<0.9 performed within 6 months of screening, with lower limb vascular stenosis and intermittent claudication.
- A person who voluntarily agrees to participate in this clinical trial in writing.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.