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.

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Administration of Sarpogrelate
  Aspirin 100mg plus Sarpogrelate 100mg
• Препарат Traditional administration of Clopidogrel
  Aspirin 100mg plus Clopidogrel 75mg

Первичные конечные точки

• Ankle brachial index [Срок оценки: Baseline, 12months]

Вторичные конечные точки (9)

• Ankle brachial index [Срок оценки: Baseline, 6months]
• Brachial ankle pulse wave velocity [Срок оценки: Baseline, 6months, 12months]
• Major cardio-cerebrovascular events [Срок оценки: Baseline, 6months, 12months]
• Lower limb angioplasty or re-operation [Срок оценки: Baseline, 6months, 12months]
• Change of Rutherford category ratio [Срок оценки: Baseline, 6months, 12months]
• Modified Rankin scale [Срок оценки: Baseline, 6months, 12months]
• National Institutes of Health Stroke Scale [Срок оценки: Baseline, 6months, 12months]
• Coronary angioplasty [Срок оценки: Baseline, 6months, 12months]
• Cerebrovascular angioplasty [Срок оценки: Baseline, 6months, 12months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Patients who are unable or contraindicated to administer antithrombotic drugs.
• 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.
• Patients identified as undergoing renal replacement therapy such as dialysis due to acute or terminal nephropathy during screening.
• 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.
• A pregnant and lactating women.
• Patients with a history of hemorrhagic tendency, conventional cerebral hemorrhage, and gastrointestinal hemorrhage.
• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06424548 · SEUMC 2023-10-009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗