NCT00129805已完成3 期
Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,510
- 主要终点
- recurrence of cerebral infarction
研究概览
简要总结
Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease.
S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrence of cerebral infarction; relative safety was also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral infarction except cardiac source of embolism
- •Onset ≧ 1 week to ≦ 6 months before randomization
- •Neurological signs persisting ≧ 1 day from onset
- •Computed tomography (CT) or magnetic resonance imaging (MRI) detection of responsible site
- •Age ≧ 20 years
- •Systolic pressure ≦ 180 mmHg; diastolic pressure ≦ 110 mmHg
排除标准
- •Functional outcome at randomization: Modified Rankin Scale = 4, 5
- •Previous or planned vascular surgery for cerebral infarction
- •History of intracranial hemorrhage
- •History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
- •Severe complications (renal or hepatic insufficiency, heart failure, hemopathy, etc.)
- •Pregnant or possibly pregnant women, or nursing mothers
- •History of sarpogrelate and aspirin sensitivity
- •Treating malignant tumor or treated within 5 years
- •Current peptic ulceration
研究组 & 干预措施
MCI-9042
Experimental
干预措施: MCI-9042 (Drug)
Aspirin
Active Comparator
干预措施: Aspirin (Drug)
结局指标
主要结局
recurrence of cerebral infarction
次要结局
- intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death
研究者
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