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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Ankle brachial index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Administration of Sarpogrelate
The intervention group will receive aspirin 100mg plus sarpogrelate 100mg
干预措施: Administration of Sarpogrelate (Drug)
Traditional administration of Clopidogrel
The control group will receive aspirin 100mg plus clopidogrel 75mg
干预措施: Traditional administration of Clopidogrel (Drug)
结局指标
主要结局
Ankle brachial index
时间窗: 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
次要结局
- Major cardio-cerebrovascular events(Baseline, 6months, 12months)
- Lower limb angioplasty or re-operation(Baseline, 6months, 12months)
- Coronary angioplasty(Baseline, 6months, 12months)
- Cerebrovascular angioplasty(Baseline, 6months, 12months)
- Brachial ankle pulse wave velocity(Baseline, 6months, 12months)
- National Institutes of Health Stroke Scale(Baseline, 6months, 12months)
- Ankle brachial index(Baseline, 6months)
- Change of Rutherford category ratio(Baseline, 6months, 12months)
- Modified Rankin scale(Baseline, 6months, 12months)
研究者
Tae-Jin Song, MD, PhD
Principal Investigator
Ewha Womans University Seoul Hospital