Beta Blockers In Acute Ischemic Stroke

Stroke Clinical Trial

— BIAS  

Official title:

Beta-Blocker in Acute Ischemic Stroke - a Prospective, Randomized, Double-blinded, Placebo-controlled Safety and Efficacy Trial of Early Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061190
• Other study ID #: BIAS1.0
• Secondary ID: ZS EK 11 165/092
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 1, 2010
• Last updated: October 12, 2015
• Start date: January 2010
• Est. completion date: April 2013

Study information

• Verified date: October 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Propranolol
oral application of 160 mg Propranolol for 30 days

Locations

Country	Name	City	State
Germany	Charité, University Berlin, Center for Stroke Research Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Wilhelm Haverkamp	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite incidence of cardiovascular and/or neurological complications including vascular death		90 days	No
Secondary	mRS and lethality		90 days	No
Secondary	number of SAEs and treatment withdrawals		90 days	Yes
Secondary	immunological & cardiological parameters		90 days	No