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Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00795288
First received: November 20, 2008
Last updated: February 23, 2016
Last verified: February 2016
Results First Received: December 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael Diringer
Organization: Washington University
phone: 314-362-2999
e-mail: diringerm@wustl.edu


Publications of Results:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00795288     History of Changes
Other Study ID Numbers: 3857 - 54118B
Study First Received: November 20, 2008
Results First Received: December 8, 2014
Last Updated: February 23, 2016
Health Authority: United States: Institutional Review Board