Beta Blockers In Acute Ischemic Stroke "BIAS"

Completed

Phase 2/3 Results N/A

Trial Description

The objective of this trial is to assess the safety and efficacy of neuro- and cardioprotective effects of propranolol in acute ischemic stroke. Furthermore, exploratory analyses of cardiologic-electrophysiologic and immunologic parameters will be performed.

Detailed Description

The main objective of this trial is to assess the efficacy and safety of propranolol in middle cerebral artery stroke patients. The primary hypothesis is as follows: Early administration of propranolol reduces the frequency of cardiovascular and/or neurological complications including vascular death in the first 30 days after acute ischemic stroke. Secondary hypotheses are as follows: Early administration of propranolol improves neurological and functional outcome of patients with acute ischemic stroke. Early administration of propranolol reduces post-stroke immunodepression and therefore lowers the rate of pneumonia after acute ischemic stroke, without increasing the frequency of auto-aggressive, CNS antigen-specific T cells. Early administration of propranolol influences alterations in cardiologic, electrophysiologic phenomenons as a reaction to autonomic dysregulation after acute ischemic stroke. Early administration of Propranolol reduces growth of infarct as determined by MRI examinations in the first 6 days.

Conditions

Interventions

  • Propranolol (Inderal)Drug
    Intervention Desc: oral application of 160 mg Propranolol for 30 days
    ARM 1: Kind: Experimental
    Label: Propranolol
    ARM 2: Kind: Experimental
    Label: Placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary composite incidence of cardiovascular and/or neurological complications including vascular death 90 days No
Secondary mRS and lethality 90 days No
Secondary number of SAEs and treatment withdrawals 90 days Yes
Secondary immunological & cardiological parameters 90 days No

Sponsors