Beta Blockers In Acute Ischemic Stroke (BIAS)

This study has been completed.

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: October 12, 2015

Last verified: October 2015

History of Changes

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 Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

Drug Information available for: Propranolol hydrochloride Propranolol Adrenergic beta-Antagonists

U.S. FDA Resources

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

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	20
Study Start Date:	January 2010
Study Completion Date:	April 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 (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

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


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 )
Study First Received:	February 1, 2010
Last Updated:	October 12, 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 Adrenergic beta-Antagonists Propranolol	Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Vasodilator Agents

ClinicalTrials.gov processed this record on June 27, 2017

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