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)

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

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Drug: Placebo; Drug: Metamizole

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo
EXPERIMENTAL: Metamizole	Drug: Metamizole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS)	after 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	up to 30 days
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
Duration of hospital stay	up to 30 days
Assessment of tympanic temperature	up to 3 days after start of treatment
Percentage of mortality	after 30 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 1998
• Primary Completion (ACTUAL): May 1, 2002

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (ESTIMATE): July 9, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Dipyrone
• Other Study ID Numbers: 1093.15