Beta Blockers In Acute Ischemic Stroke (BIAS)

October 12, 2015 updated by: Wilhelm Haverkamp

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité, University Berlin, Center for Stroke Research Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Propranolol
oral application of 160 mg Propranolol for 30 days
ACTIVE_COMPARATOR: Propranolol
Drug: Propranolol
oral application of 160 mg Propranolol for 30 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wilhelm Haverkamp

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Wilhelm Haverkamp, Prof. Dr. med., Charité, University Berlin, Center for Stroke Research Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 2, 2010

First Posted (ESTIMATE)

February 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIAS1.0
  • ZS EK 11 165/09 (OTHER: ethic's committee of the German federal state Berlin)
  • 2008-007031-41 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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