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
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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:
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 ]
| 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) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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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 2008-007031-41 |
| Study First Received: | February 1, 2010 |
| Last Updated: | October 12, 2015 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by 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 September 27, 2016