Clinical trial NCT02184260: Efficacy and Safety of Metamizole Versus Placebo as Antithermic Therapy in the Acute Phase of Ischemic Stroke
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Stroke
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical efficacy and safety of Metamizole 2 g i.v. versus placebo, as antithermic therapy in the acute phase of ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS)
timeFrame: after 30 days
Secondary outcomes:
measure: Assessment of functional outcome according to SSS
timeFrame: Baseline, after 3 and 7 days
measure: Number of patients with score of SSS < 30 points
timeFrame: after 30 days
measure: Clinical impression assessed on the Modified Rankin Scale
timeFrame: after 30 days
measure: Effect on the activities of daily living assessed on Barthel Index
timeFrame: after 30 days
measure: Number of patients requiring rescue therapy
timeFrame: up to 30 days
measure: Duration of hospital stay
timeFrame: up to 30 days
measure: Assessment of tympanic temperature
timeFrame: up to 3 days after start of treatment
measure: Percentage of mortality
timeFrame: after 30 days
measure: Number of patients with adverse events
timeFrame: up to 30 days
Other outcomes:
Locations:
Study officials:
References: