Beta Blockers In Acute Ischemic Stroke

Phase 2

Completed

• Conditions: Stroke
• Interventions: Drug: Propranolol

• Registration Number: NCT01061190
• Lead Sponsor: Wilhelm Haverkamp

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Primary Completion: 2011-10
• Study Completion: 2013-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-12
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Propranolol	-
Propranolol	Propranolol	-

Primary Outcome Measures

Name	Time	Method
composite incidence of cardiovascular and/or neurological complications including vascular death	90 days

Secondary Outcome Measures

Name	Time	Method
mRS and lethality	90 days
number of SAEs and treatment withdrawals	90 days
immunological & cardiological parameters	90 days

Trial Locations

Locations (1)

Charité, University Berlin, Center for Stroke Research Berlin; 🇩🇪 Berlin, Germany