NCT02184260终止4 期
A Randomized, Multicentre, Double-blind Clinical Trial of Metamizole 2 g /8 h, I.V. Ampoules, Versus Placebo Each 8 h, I.V. Ampoules, Administered During 3 Days Consecutively as Antithermic Therapy in the Acute Phase of Ischemic Stroke. A 30-day Study. (ATIS Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 58
- 主要终点
- Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS)
研究概览
简要总结
Clinical efficacy and safety of Metamizole 2 g i.v. versus placebo, as antithermic therapy in the acute phase of ischemic stroke.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Hemispherical cerebral infarction with moderate (SSS = 30-44 points) or severe (SSS < 30 points) deficit at the time of inclusion. However, only patients with a score between 15 and 44 points on the SSS scale will be included
- •Tympanic temperature between 37 and 38 degrees Celsius. The relationship between tympanic and body temperature is as follows: tympanic temperature = body temperature + 0.3 degrees Celsius
- •Onset of cerebral infarction symptoms within the last 24 hours. When the time of onset of symptoms is unknown (e.g. ictus occurred while sleeping) the last time when the patient was asymptomatic will be considered as time of onset
- •Normal cerebral CT scan or with signs of cerebral infarction
- •Patient's written or orally witnessed informed consent in accordance with local legislation, guidelines of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)-GCP
排除标准
- •Patients with a history of granulocytopenia, thrombocytopenia or aplastic blood diseases of any etiology. Known hypersensitivity to salicylates, pyrazolones and other nonsteroidal antiinflammatory drugs (NSAIDs). NSAID-induced bronchial asthma
- •Patients with a history indicating a life expectancy less than 30 days or patients whom the investigator thinks that it will not be possible to follow for entire 30 days
- •Non-cooperative
- •Patients with neurological sequelae of a previous stroke
- •Cerebral hemorrhage
- •Pregnancy, lactation
- •Participation in another clinical trial
- •Intake of acetylsalicylic acid (ASA) > 300 mg per day, paracetamol or NSAIDs during the 24 hours prior to administration of the study medication
- •Seizures at the start of the stroke
研究组 & 干预措施
Metamizole
Experimental
干预措施: Metamizole (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS)
时间窗: after 30 days
次要结局
- Effect on the activities of daily living assessed on Barthel Index(after 30 days)
- Duration of hospital stay(up to 30 days)
- Number of patients with score of SSS < 30 points(after 30 days)
- Clinical impression assessed on the Modified Rankin Scale(after 30 days)
- Number of patients requiring rescue therapy(up to 30 days)
- Assessment of functional outcome according to SSS(Baseline, after 3 and 7 days)
- Percentage of mortality(after 30 days)
- Assessment of tympanic temperature(up to 3 days after start of treatment)
- Number of patients with adverse events(up to 30 days)
研究者
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