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

February 1, 2010
February 23, 2012
January 2010
October 2011   (final data collection date for primary outcome measure)
composite incidence of cardiovascular and/or neurological complications including vascular death [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01061190 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Beta Blockers In Acute Ischemic Stroke
Beta-Blocker in Acute Ischemic Stroke - a Prospective, Randomized, Double-blinded, Placebo-controlled Safety and Efficacy Trial of Early Treatment

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Stroke
Drug: Propranolol
oral application of 160 mg Propranolol for 30 days
  • Active Comparator: Propranolol
    Intervention: Drug: Propranolol
  • Placebo Comparator: Placebo
    Intervention: Drug: Propranolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
250
October 2013
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01061190
BIAS1.0, ZS EK 11 165/09, 2008-007031-41
Yes
Wilhelm Haverkamp, Charite University, Berlin, Germany
Wilhelm Haverkamp
German Federal Ministry of Education and Research
Principal Investigator: Wilhelm Haverkamp, Prof. Dr. med. Charité, University Berlin, Center for Stroke Research Berlin
Charite University, Berlin, Germany
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP