Beta Blockers In Acute Ischemic Stroke

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Drug: Propranolol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propranolol<br> | Drug: Propranolol<br>* oral application of 160 mg Propranolol for 30 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Propranolol<br>* oral application of 160 mg Propranolol for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite incidence of cardiovascular and/or neurological complications including vascular death |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS and lethality |  | 90 days | 
| number of SAEs and treatment withdrawals |  | 90 days | 
| immunological & cardiological parameters |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke