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

Terminated

Phase 4 Results N/A

Trial Description

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

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
  • Metamizole Drug
    ARM 1: Kind: Experimental
    Label: Metamizole

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS) after 30 days No
Secondary Assessment of functional outcome according to SSS Baseline, after 3 and 7 days No
Secondary Number of patients with score of SSS < 30 points after 30 days No
Secondary Clinical impression assessed on the Modified Rankin Scale after 30 days No
Secondary Effect on the activities of daily living assessed on Barthel Index after 30 days No
Secondary Number of patients requiring rescue therapy up to 30 days No
Secondary Duration of hospital stay up to 30 days No
Secondary Assessment of tympanic temperature up to 3 days after start of treatment No
Secondary Percentage of mortality after 30 days No
Secondary Number of patients with adverse events up to 30 days No

Sponsors