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Beta Blocker
Metoprolol for Subarachnoid Hemorrhage (BADCATS Trial)
Phase 4
Recruiting
Led By Madeleine Puissant, MD, PhD
Research Sponsored by Madeleine Puissant
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >18 years
Neuro-imaging confirmed non-traumatic subarachnoid hemorrhage
Must not have
Other forms of traumatic or non-traumatic intracranial bleed including intracerebral hemorrhage (ICH), subdural hemorrhage, epidural hemorrhage
Unstable vital signs not amenable to beta-1 adrenergic receptor inhibitor (B1ARi) administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15-weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial aims to see if giving metoprolol early after a certain type of brain bleeding (non-traumatic subarachnoid hemorrhage) has any positive effects.
Who is the study for?
This trial is for adults over 18 who have had a non-traumatic subarachnoid hemorrhage, confirmed by neuro-imaging. It's not specified here, but typically there would be more criteria about the patient's health status and possibly other factors like how recently they've had the hemorrhage.
What is being tested?
The BADCATS trial is testing whether giving metoprolol early after a brain aneurysm that caused bleeding (subarachnoid hemorrhage) can reduce heart damage and inflammation compared to a placebo.
What are the potential side effects?
Metoprolol may cause side effects such as tiredness, dizziness, cold hands and feet, or upset stomach. However, specific side effects related to this trial are not listed here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have a brain bleed not caused by injury, confirmed by a scan.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a brain bleed, such as a stroke or head injury.
Select...
My vital signs are unstable and I can't take beta-1 blockers.
Select...
I have had severe heart failure in the past.
Select...
My brain bleed was caused by a head injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15-weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Delta QTc length
Delta neutrophil activity
Secondary study objectives
Adverse events
Evidence of Clinical Vasospasm
Hospital Length of Stay (LOS)
+6 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Metoprolol (Beta-adrenergic blockade)Experimental Treatment1 Intervention
Patients will receive metoprolol during the first 72-hours of hospitalization after non-traumatic SAH.
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive placebo during the first 72-hours of hospitalization after non-traumatic SAH.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metoprolol
2006
Completed Phase 4
~3730
Find a Location
Who is running the clinical trial?
Madeleine PuissantLead Sponsor
MaineHealthOTHER
74 Previous Clinical Trials
43,755 Total Patients Enrolled
Madeleine Puissant, MD, PhDPrincipal InvestigatorMaineHealth