Beta Blockers In Acute Ischemic Stroke (BIAS)

This study has suspended participant recruitment.
(recruiting numbers were insufficient)
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Wilhelm Haverkamp, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01061190
First received: February 1, 2010
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Stroke
Drug: Propranolol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Beta-Blocker in Acute Ischemic Stroke - a Prospective, Randomized, Double-blinded, Placebo-controlled Safety and Efficacy Trial of Early Treatment

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • composite incidence of cardiovascular and/or neurological complications including vascular death [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mRS and lethality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • number of SAEs and treatment withdrawals [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • immunological & cardiological parameters [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2010
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propranolol Drug: Propranolol
oral application of 160 mg Propranolol for 30 days
Placebo Comparator: Placebo Drug: Propranolol
oral application of 160 mg Propranolol for 30 days

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061190

Locations
Germany
Charité, University Berlin, Center for Stroke Research Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Wilhelm Haverkamp
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Wilhelm Haverkamp, Prof. Dr. med. Charité, University Berlin, Center for Stroke Research Berlin
  More Information

No publications provided

Responsible Party: Wilhelm Haverkamp, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01061190     History of Changes
Other Study ID Numbers: BIAS1.0, ZS EK 11 165/09, 2008-007031-41
Study First Received: February 1, 2010
Last Updated: February 23, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Adrenergic beta-Antagonists
Propranolol
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 15, 2014