Beta Blockers In Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-04-30

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.

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Propranolol

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

oral application of 160 mg Propranolol for 30 days

Placebo

Group Type PLACEBO_COMPARATOR

Propranolol

Intervention Type DRUG

oral application of 160 mg Propranolol for 30 days

Interventions

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Propranolol

oral application of 160 mg Propranolol for 30 days

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No