BIAS: Beta Blockers In Acute Ischemic Stroke

Sponsor

Wilhelm Haverkamp (Other)

Overall Status

Completed

CT.gov ID

NCT01061190

Collaborator

German Federal Ministry of Education and Research (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jan 1, 2010

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

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

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wilhelm Haverkamp, MD, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01061190

Other Study ID Numbers:

BIAS1.0
ZS EK 11 165/09
2008-007031-41

First Posted:

Feb 3, 2010

Last Update Posted:

Oct 14, 2015

Last Verified:

Oct 1, 2015

Keywords provided by Wilhelm Haverkamp, MD, Charite University, Berlin, Germany

Stroke

Additional relevant MeSH terms:

Stroke

Ischemic Stroke

Propranolol

Study Results

No Results Posted as of Oct 14, 2015