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

Primary Purpose

Stroke

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Metamizole

Placebo

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metamizole

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS)

Secondary Outcome Measures

Assessment of functional outcome according to SSS

Number of patients with score of SSS < 30 points

Clinical impression assessed on the Modified Rankin Scale

Effect on the activities of daily living assessed on Barthel Index

Number of patients requiring rescue therapy

Duration of hospital stay

Assessment of tympanic temperature

Percentage of mortality

Number of patients with adverse events

Full Information

NCT ID

NCT02184260

First Posted

July 8, 2014

Last Updated

July 9, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02184260

Brief Title

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

Acronym

ATIS

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

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Terminated

Study Start Date

December 1998 (undefined)

Primary Completion Date

May 2002 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metamizole

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Metamizole

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS)

Time Frame

after 30 days

Secondary Outcome Measure Information:

Title

Assessment of functional outcome according to SSS

Time Frame

Baseline, after 3 and 7 days

Title

Number of patients with score of SSS < 30 points

Time Frame

after 30 days

Title

Clinical impression assessed on the Modified Rankin Scale

Time Frame

after 30 days

Title

Effect on the activities of daily living assessed on Barthel Index

Time Frame

after 30 days

Title

Number of patients requiring rescue therapy

Time Frame

up to 30 days

Title

Duration of hospital stay

Time Frame

up to 30 days

Title

Assessment of tympanic temperature

Time Frame

up to 3 days after start of treatment

Title

Percentage of mortality

Time Frame

after 30 days

Title

Number of patients with adverse events

Time Frame

up to 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1093/1093.15_U04-1020.pdf

Description

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

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