Beta Blockers In Acute Ischemic Stroke (BIAS)

Wilhelm Haverkamp

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stroke

Treatments: Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01061190

BIAS1.0

2008-007031-41 (EudraCT Number)

ZS EK 11 165/09 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Propranolol

Active Comparator group

Treatment:

Drug: Propranolol

Placebo

Placebo Comparator group

Treatment:

Drug: Propranolol