Administration of Sarpogrelate
DrugAspirin 100mg plus Sarpogrelate 100mg
NCT Number: NCT06424548
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.
Trial opening soon.
Get Notified19 year and older
All sexes
Interventional
Not applicable
A total of 100 subjects are recruited and divided into a intervention group and a control group through randomization.
In this clinical trial, the intervention group and the control group are assigned 1:1.
The researcher allocates 1:1 to the intervention group or control group through a two-way random number table on the assignment date in the order of the subjects who are satisfied with the Inclusion and exclusion criteria and agreed to the study.
This study is a prospective open randomized clinical trial that can confirm which group the subjects themselves were assigned to. After randomization, the drug is prescribed and the outcome variable is checked at 12 months.
During the course of the clinical trial, the examiner and researchers carefully observe the presence or absence of adverse events during the follow-up period after randomization, and closely observe outcome variables, including neurological changes.
Visit after 6 months and 12 months during the clinical trial period to confirm the effectiveness and safety. When an event corresponding to the outcome variable occurs, the researcher first plans to implement appropriate medical measures in this regard.
Both groups will be conducted in compliance with the usual diagnosis and treatment process, and in particular, all subjects will be tested and treated appropriately according to the standard treatment guidelines for ischemic stroke during the clinical trial period.
The purpose of this study is to determine whether there is a difference in the improvement and safety of the ankle-brachial arterial pressure index of aspirin+sarpogrelate and aspirin+clopidogrel in stroke patients with decreased ankle-brachial arterial pressure index and intermittent claudication.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aspirin 100mg plus Sarpogrelate 100mg
Aspirin 100mg plus Clopidogrel 75mg
Time frame: Baseline, 12months
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
Time frame: Baseline, 6months
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
Time frame: Baseline, 6months, 12months
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
Time frame: Baseline, 6months, 12months
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)
Time frame: Baseline, 6months, 12months
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.
Time frame: Baseline, 6months, 12months
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)
Time frame: Baseline, 6months, 12months
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)
Time frame: Baseline, 6months, 12months
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.
Time frame: Baseline, 6months, 12months
Confirmation that coronary angioplasty was performed at 6 months and 12 months after the first dose of the drug in the clinical trial.
Time frame: Baseline, 6months, 12months
Confirmation that cerebrovascular angioplasty was performed at 6 months and 12 months after the first dose of the drug in the clinical trial.
Contact information is provided by the study sponsor or research team.
Ewha Womans University Seoul Hospital
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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