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Beta Blockers In Acute Ischemic Stroke (BIAS)

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ClinicalTrials.gov Identifier: NCT01061190
Recruitment Status : Completed
First Posted : February 3, 2010
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Wilhelm Haverkamp, Charite University, Berlin, Germany

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Stroke Drug: Propranolol Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : April 2013

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. composite incidence of cardiovascular and/or neurological complications including vascular death [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. mRS and lethality [ Time Frame: 90 days ]
  2. number of SAEs and treatment withdrawals [ Time Frame: 90 days ]
  3. immunological & cardiological parameters [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ( Other Identifier: ethic's committee of the German federal state Berlin )
2008-007031-41 ( EudraCT Number )
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Wilhelm Haverkamp, Charite University, Berlin, Germany:
Stroke

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