Beta Blockers In Acute Ischemic Stroke (BIAS)
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ClinicalTrials.gov Identifier: NCT01061190 |
Recruitment Status
:
Completed
First Posted
: February 3, 2010
Last Update Posted
: October 14, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke | Drug: Propranolol | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 : | January 2010 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | April 2013 |
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
|
- composite incidence of cardiovascular and/or neurological complications including vascular death [ Time Frame: 90 days ]
- mRS and lethality [ Time Frame: 90 days ]
- number of SAEs and treatment withdrawals [ Time Frame: 90 days ]
- immunological & cardiological parameters [ Time Frame: 90 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061190
Germany | |
Charité, University Berlin, Center for Stroke Research Berlin | |
Berlin, Germany, 10117 |
Principal Investigator: | Wilhelm Haverkamp, Prof. Dr. med. | Charité, University Berlin, Center for Stroke Research Berlin |
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 ) |
First Posted: | February 3, 2010 Key Record Dates |
Last Update Posted: | October 14, 2015 |
Last Verified: | October 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 |