Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 4
- 主要终点
- Aspirin Resistance (ARU ≥ 550)
研究概览
简要总结
This study will recruit 316 ischemic stroke patients taking aspirin.
They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month.
The primary outcome variable of this study is rate of biochemical aspirin resistance on the Ultra Rapid Platelet Function Assay-ASA.
详细描述
[Goal] To reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance.
[Trial Design] Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
[Participants] Ischemic stroke patients taking aspirin
[Methods]
- Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
- Investigational product: Cilostazol 200mg (100mg twice per day)
- Concomitant medication: Aspirin 100 mg per day
- Medication Duration: 1 month
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic cerebral infarction documented on MRI or CT
- •More than 35 years of age
- •Patients taking aspirin 100mg a day for 2 weeks or more before randomization
排除标准
- •Patients taking any antiplatelets other than aspirin within 2 weeks before randomization
- •Patients taking any anticoagulants within 2 weeks before randomization
- •Patients taking thrombolytic therapy within 2 weeks before randomization
- •Patients taking any NSAIDs within 2 weeks before randomization
- •Patients who need to take NSAIDs regularly (e.g. rheumatic arthritis).
- •Bleeding diathesis
- •Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl)
- •Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
- •Pregnant or lactating patients
- •Patients scheduled for angioplasty or revascularization procedures within 4 weeks
- •Patients scheduled for any surgery or invasive procedures within 4 weeks
- •Patients having acute coronary syndrome
研究组 & 干预措施
1 Cilostazol
100mg of Cilostazol twice a day
干预措施: Cilostazol (Drug)
Placebo
matching placebo to cilostazol
干预措施: placebo (Drug)
结局指标
主要结局
Aspirin Resistance (ARU ≥ 550)
时间窗: 4 weeks after treatment
The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients
次要结局
- Aspirin Resistance (ARU ≥ 500)(4 weeks after reatment)
- Bleeding Time (BT)(4 weeks after reatment)
- Fatal or Major Bleeding Complications;(events ocurred during study medication after randomization)
- Any Bleeding Complications(events ocurred during study medication after randomization)
- Difference of Post-treatment ARU and Baseline ARU(baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication)
- Post-treatment ARU(after 4 weeks treatment)