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

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 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:

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

U.S. FDA Resources

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:


Propranolol Adrenergic Agents Adrenergic Antagonists Adrenergic beta-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 March 03, 2015

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