JPRN-jRCT1080220034已完成4 期
Post-marketing study of cilostazol: Study to confirm efficacy in preventing recurrence of cerebral infarction in comparison with aspirin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,757
研究概览
简要总结
The results of this study demonstrated that cilostazol (200 mg/day) was not only noninferior, but actually superior to aspirin (81 mg/day) in preventing recurrence of stroke in patients with cerebral infarction (excluding those with cardiogenic cerebral embolism).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •(1) Patients with stable medical conditions after occurrence of cerebral infarction,
- •(2) Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI,
- •(3) Patients aged 20 to 80 years old (inclusive) at time of consent,
- •(4) Patients with no cardiac diseases that may be associated with cardiogenic cerebral embolism,
- •(5) Patients without asymptomatic cerebral infarction,
- •(6) Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction,
- •(7) Patients without severe disturbances/impairments following occurrence of cerebral infarction
排除标准
- •(1) Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
- •(2) Pregnant, possibly pregnant, or nursing women
- •(3) Patients with ischemic heart failure
- •(4) Patients with peptic ulcer
- •(5) Patients with severer blood disorders
- •(6) Patients with severe hepatic or renal
- •(7) Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
- •(8) Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
- •(9) Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
- •(10) Patients who are being treated with ticlopidine hydrochloride
- •(11) Patients who are participating in another study for an investigational drug
- •(12) Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
研究者
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