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Efficacy and Safety of Metamizole Versus Placebo as Antithermic Therapy in the Acute Phase of Ischemic Stroke (ATIS)

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ClinicalTrials.gov Identifier: NCT02184260
Recruitment Status : Terminated
First Posted : July 9, 2014
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Stroke Drug: Metamizole Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 1998
Actual Primary Completion Date : May 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Dipyrone

Arm Intervention/treatment
Experimental: Metamizole Drug: Metamizole
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS) [ Time Frame: after 30 days ]

Secondary Outcome Measures :
  1. Assessment of functional outcome according to SSS [ Time Frame: Baseline, after 3 and 7 days ]
  2. Number of patients with score of SSS < 30 points [ Time Frame: after 30 days ]
  3. Clinical impression assessed on the Modified Rankin Scale [ Time Frame: after 30 days ]
  4. Effect on the activities of daily living assessed on Barthel Index [ Time Frame: after 30 days ]
  5. Number of patients requiring rescue therapy [ Time Frame: up to 30 days ]
  6. Duration of hospital stay [ Time Frame: up to 30 days ]
  7. Assessment of tympanic temperature [ Time Frame: up to 3 days after start of treatment ]
  8. Percentage of mortality [ Time Frame: after 30 days ]
  9. Number of patients with adverse events [ Time Frame: up to 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02184260     History of Changes
Other Study ID Numbers: 1093.15
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Dipyrone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antipyretics