Beta Blockers In Acute Ischemic Stroke

Beta-Blocker in Acute Ischemic Stroke - a Prospective, Randomized, Double-blinded, Placebo-controlled Safety and Efficacy Trial of Early Treatment

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01061190

Acronym

BIAS

Enrollment

Registered

2010-02-03

Start date

2010-01-31

Completion date

2013-04-30

Last updated

2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke

Brief summary

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.

Interventions

DRUGPropranolol

oral application of 160 mg Propranolol for 30 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Symptom onset within 18 hours * Acute ischemic MCA-territory stroke * Patients with suspected stroke in MCA-territory and a) NIHSS \> 3 or b) imaging evidence of MCA-infarction

Exclusion criteria

* Patients already receiving beta-blockers * Anti-arrhythmic, antiinfectious, antiinflammatory or immunosuppressive therapy * Patients with a major heart disease, hypotension, bradycardia or any contraindication to the use of Propranolol

Design outcomes

Primary

Measure	Time frame
composite incidence of cardiovascular and/or neurological complications including vascular death	90 days

Secondary

Measure	Time frame
mRS and lethality	90 days
number of SAEs and treatment withdrawals	90 days
immunological & cardiological parameters	90 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026