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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014