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Beta Blockers In Acute Ischemic Stroke (BIAS)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Propranolol
Sponsored by
Wilhelm Haverkamp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Charité, University Berlin, Center for Stroke Research Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Propranolol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

composite incidence of cardiovascular and/or neurological complications including vascular death

Secondary Outcome Measures

mRS and lethality
number of SAEs and treatment withdrawals
immunological & cardiological parameters

Full Information

First Posted
February 1, 2010
Last Updated
October 12, 2015
Sponsor
Wilhelm Haverkamp
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01061190
Brief Title
Beta Blockers In Acute Ischemic Stroke
Acronym
BIAS
Official Title
Beta-Blocker in Acute Ischemic Stroke - a Prospective, Randomized, Double-blinded, Placebo-controlled Safety and Efficacy Trial of Early Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wilhelm Haverkamp
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propranolol
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
oral application of 160 mg Propranolol for 30 days
Primary Outcome Measure Information:
Title
composite incidence of cardiovascular and/or neurological complications including vascular death
Time Frame
90 days
Secondary Outcome Measure Information:
Title
mRS and lethality
Time Frame
90 days
Title
number of SAEs and treatment withdrawals
Time Frame
90 days
Title
immunological & cardiological parameters
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilhelm Haverkamp, Prof. Dr. med.
Organizational Affiliation
Charité, University Berlin, Center for Stroke Research Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité, University Berlin, Center for Stroke Research Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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Beta Blockers In Acute Ischemic Stroke

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