Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Perihematomal edema change volume percentage
研究概览
简要总结
This trial is a phase IIa human clinical study, in which 60 patients with intracerebral hemorrhage (ICH) at basal ganglion or thalamus within 6 h after onset will be enrolled. Patients will be randomly assigned as treatment group or control group as 1:1 distribution. Early initiation of celecoxib within 6 h after ICH and treatment for 21 days will be performed. The safety will be evaluated by drug adverse effects. The efficacy will be assessed by hematoma expansion, brain edema, and 3-month modified Rankin scale.
详细描述
A phase IIa human clinical trial will be performed to clarify the safety and efficacy of using usual dose of celecoxib (200 mg/day) for 21 days starting within 6 hours after onset of ICH. Totally 60 patients will be enrolled prospectively, and the case number was estimated by statistical methods for the percentage of participants with increased perihematomal edema volume shown in the previous clinical trial (Lee et al., 2013) (estimated by G-power software, settings as: exact test, one sample test, α = 0.05, power = 0.95). Patients will be randomly assigned as treatment group or control group as 1:1 distribution.
Intervention: Celecoxib 200 mg per dose, started within 6 h after onset, then one dose per day for 21 days in the treatment group. The low dose of Celecoxib will be used to minimize the side effect of Celecoxib. No trial medication will be given for the control group. Pregnancy will be excluded at enrollment and prevented throughout the treatment period in female cases at reproductive ages.
Evaluations:
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Brain CT:
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Initial brain CT: for initial hematoma volume (length * width * height /2)
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Brain CT on day 2 for final hematoma volume and hematoma expansion
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Brain CT on day 7±1 for perihematomal edema and hematoma resolution
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Neurological functions: NIHSS score, GCS score, modified Rankin scale (mRS) on day 1, 2, 7±2, 14±2, 21±2, and mRS at 3 months
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Renal function (creatinine) on day 1, then once per week during day 2-7, day 8-14 and 15-21
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Gastrointestinal bleeding evens within 21 days
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Myocardial infarction evens within 21 days
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Blood sampling on day 1, 7±2, and 21±2
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ICH patients able to take the first dose within 6 hours after onset
- •ICH location at basal ganglion or thalamus
- •ICH volume < 30 mL
- •Normal renal function (creatinine [Cr] ≤ 1.3 mg/dL)
- •No surgical indication
- •Signed informed consent
- •Consciousness clear or mild drowsiness
- •Age 20-80 years old
排除标准
- •Allergy to celecoxib or other non-steroid anti-inflammatory drugs (NSAIDs)
- •Post-coronary artery bypass graft (CABG) within 14 days
- •Previous myocardial infarction
- •Previous peptic ulcer disease
- •Abnormal renal function (Cr > 1.3 mg/dL)
- •Surgery for this ICH
- •Pregnancy or under breast feeding (If the female case is not sure about pregnancy, pregnancy test will be performed)
- •Premorbid mRS > or = 3
- •Previous ICH not at basal ganglia or thalamus
- •Coagulation abnormality (abnormal PT/PTT), or taking anticoagulant or antiplatelet
- •Abnormal liver function (ALT > 3x upper limit)
- •History of severe bleeding event, requiring admission or blood transfusion
- •History of stenting or valve replacement, requiring long-term using antithrombotics
研究组 & 干预措施
Celebrex treatment arm
Celecoxib 200 mg/dose, started within 6 h after onset, then one dose per day for 21 days.
干预措施: Celecoxib 200mg (Drug)
结局指标
主要结局
Perihematomal edema change volume percentage
时间窗: Day 2, 7
(Followed perihematomal edema volume - initial perihematomal edema volume) / initial perihematomal edema volume x100%
Percentage of participants with perihematomal edema volume change > 20%
时间窗: Day 2, 7
Participants with \[(followed perihematomal edema volume - initial perihematomal edema volume) / initial perihematomal edema volume x100%\] larger than 20% / total participants x100%
Hematoma expansion volume percentage
时间窗: Day 2
(Followed hematoma volume - initial hematoma volume) / initial hematoma volume x100%
次要结局
- Hematoma and perihematomal edema expansion volume(Day 2, 7±1)
- Percentage of participants with adverse events (AEs)(Day 1-21)
- Hematoma expansion volume(Day 2)
- Hematoma and perihematomal edema expansion percentage(Day 2, 7±1)
- Percentage of participants with hematoma expansion (33% relative or 12.5 mL absolute volume increase)(Day 2)
- Perihematomal edema increase volume(Day 2, 7±1)
- Change in National Institutes of Health Stroke Scale (NIHSS)(Day 21±2)
- modified Rankin scale (mRS) score(3-month)