Efficacy and Safety of Metamizole Versus Placebo as Antithermic Therapy in the Acute Phase of Ischemic Stroke
ATIS
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)
1 other identifier
interventional
58
0 countries
N/A
Brief Summary
Clinical efficacy and safety of Metamizole 2 g i.v. versus placebo, as antithermic therapy in the acute phase of ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 8, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedJuly 10, 2014
July 1, 2014
3.4 years
July 8, 2014
July 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS)
after 30 days
Secondary Outcomes (9)
Assessment of functional outcome according to SSS
Baseline, after 3 and 7 days
Number of patients with score of SSS < 30 points
after 30 days
Clinical impression assessed on the Modified Rankin Scale
after 30 days
Effect on the activities of daily living assessed on Barthel Index
after 30 days
Number of patients requiring rescue therapy
up to 30 days
- +4 more secondary outcomes
Study Arms (2)
Metamizole
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age over 18 years
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2014
First Posted
July 9, 2014
Study Start
December 1, 1998
Primary Completion
May 1, 2002
Last Updated
July 10, 2014
Record last verified: 2014-07