Stroke Clinical Trial
Official title:
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.
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 | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2028 |
Est. primary completion date | June 30, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ewha Womans University Seoul Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ankle brachial index | The value of the ankle brachial index evaluated 12 months after the first dose of the clinical trial drug. Ankle brachial index : normal range > 0.9, abnormal range < 0.9 | Baseline, 12months | |
Secondary | Ankle brachial index | The value of the ankle brachial index evaluated 6 months after the first dose of the clinical trial drug. Ankle brachial index : normal range > 0.9, abnormal range < 0.9 | Baseline, 6months | |
Secondary | Brachial ankle pulse wave velocity | The value of Brachial ankle pulse wave velocity evaluated 6 months and 12months after the first dose of the clinical trial drug. Brachial ankle pulse wave velocity : normal range 1000~1500 cm/sec, abnormal range > 1600 cm/sec | Baseline, 6months, 12months | |
Secondary | Major cardio-cerebrovascular events | Major cardio-cerebrovascular events that occurred within 6 months and 12 months after the first medication related to the clinical trial. (Stroke, myocardial infarction, non-stable angina, lower limb vascular intervention, surgery, death) | Baseline, 6months, 12months | |
Secondary | Lower limb angioplasty or re-operation | Whether or not to perform lower limb angioplasty or re-operation, evaluated 6 months and 12 months after the first dose of the clinical trial drug. | Baseline, 6months, 12months | |
Secondary | Change of Rutherford category ratio | Change of Rutherford category ratio, a symptom scale related to vascular stenosis of the lower extremities, evaluated 6 months and 12 months after the first dose of the clinical trial drug. (Grade 0-Asymptomatic, Grade 1-Mild claudication, Grade 2-Moderate claudication, Grade 3-Severe claudication, Grade 4-Ischemic rest pain, Grade 5-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia, Grade 6-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable) | Baseline, 6months, 12months | |
Secondary | Modified Rankin scale | Modified Rankin scale evaluated 6 months and 12 months after the first dose of the clinical trial drug. (0-No symptoms at all, 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance, 4-Moderate to severe disability; unable to walk without assistance, and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention, 6-Death) | Baseline, 6months, 12months | |
Secondary | National Institutes of Health Stroke Scale | Changes in NIHSS evaluated at 6 months and 12 months after the first dose of the clinical trial drug. National Institutes of Health Stroke Scale score of 0 (lowest point) means normal, and a score of 42 (high point) means severe dysfunction caused by stroke, so the higher the score, the more severe the stroke. | Baseline, 6months, 12months | |
Secondary | Coronary angioplasty | Confirmation that coronary angioplasty was performed at 6 months and 12 months after the first dose of the drug in the clinical trial. | Baseline, 6months, 12months | |
Secondary | Cerebrovascular angioplasty | Confirmation that cerebrovascular angioplasty was performed at 6 months and 12 months after the first dose of the drug in the clinical trial. | Baseline, 6months, 12months |
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