Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Clinical-pharmacological Dose-response Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- The maximum intensity of platelet aggregation on the last day of medication and as post-treatment percentage inhibition of the maximum intensity of platelet aggregation at baseline [(baseline - post-treatment )/baseline × 100 in each subject].
研究概览
简要总结
Sarpogrelate is an antiplatelet agent that decreases 5-hydroxytryptamine( 5-HT )levels in platelets via blockade of 5-HT2 receptors, has been used in atherosclerotic peripheral arterial disease.
The present double-blind controlled clinical pharmacology study was performed on 45 patients with cerebral infarction, who were given 75, 150, or 300 mg three times daily of sarpogrelate for 7 days in order to evaluate the dose-response relationship in terms of the precisely measured inhibition of platelet aggregation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral infarction except cardiac source of embolism based on the NINDSⅢclassification
- •Neurological signs persisting≧ 1 day from onset
- •Defined onset of symptoms, and stable condition at the period of enrollment
- •CT or MRI detection of responsible site
- •Systolic pressure≦180 mmHg, Diastolic pressure≦110 mmHg
- •The maximum intensity of platelet aggregation is above 15 % induced by serotonin (1µM) and epinephrine (3µM) on the day of prior to the first medication
- •Written informed consent must be obtained from the patients before enrollment into the study
排除标准
- •Functional outcome at randomization: Modified Rankin Scale=4, 5
- •Previous or planned for vascular surgery to cerebral infarction
- •History of intracranial hemorrhage
- •History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
- •With severe complications ( renal or hepatic insufficiency, heart failure, hemopathy, and so on )
- •Treating malignant tumor
- •Pregnant or possibly pregnant women, or nursing mothers
- •History of sarpogrelate sensitivity
- •Previously entered in other clinical trials within 3 months
- •Less than 3 months since any other clinical trial
- •Judged by investigator to be unsuitable for the study
研究组 & 干预措施
group L
25mg sarpogrelate
干预措施: MCI-9042 (Drug)
group M
50mg sarpogrelate
干预措施: MCI-9042 (Drug)
group H
100mg sarpogrelate
干预措施: MCI-9042 (Drug)
结局指标
主要结局
The maximum intensity of platelet aggregation on the last day of medication and as post-treatment percentage inhibition of the maximum intensity of platelet aggregation at baseline [(baseline - post-treatment )/baseline × 100 in each subject].
次要结局
未报告次要终点