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Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795288
First Posted: November 21, 2008
Last Update Posted: March 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
Results First Submitted: December 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Subarachnoid Hemorrhage
Interventions: Drug: Simvastatin, 80 mg/day for 21 days
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
Simvastatin All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.

Participant Flow:   Overall Study
    Placebo   Simvastatin
STARTED   21   21 
COMPLETED   21   21 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Simvastatin

Simvastatin, 80 mg/day

Simvastatin, 80 mg/day for 21 days: Active treatment group

Control placebo: Control group
Total Total of all reporting groups

Baseline Measures
   Simvastatin   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   21   42 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   21   21   42 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 59  (12)   60  (10)   60  (11) 
Gender 
[Units: Participants]
     
Female   12   14   26 
Male   9   7   16 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   2   3   5 
White   19   18   37 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   21   21   42 


  Outcome Measures
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1.  Primary:   Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk   [ Time Frame: 7-10 days after hemorrhage ]

2.  Primary:   Cerebral Autoregulation During Peak Period of Vasospasm Risk   [ Time Frame: 7-10 days after hemorrhage ]

3.  Secondary:   Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk   [ Time Frame: 7-10 days after hemorrhage ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information