IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Beta Blockers In Acute Ischemic Stroke (BIAS)
This study has been completed.
Sponsor:
Wilhelm Haverkamp
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: 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 |
Resource links provided by NLM:
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
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 Propranolol Adrenergic beta-Antagonists |
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 August 17, 2017