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Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

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.
ClinicalTrials.gov Identifier: NCT00795288
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : January 16, 2015
Last Update Posted : March 21, 2016
Information provided by (Responsible Party):

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

  Baseline Characteristics

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.
No text entered.

Reporting Groups

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 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   21   21   42 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 59  (12)   60  (10)   60  (11) 
[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

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

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
No text entered.

  More Information

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
First Submitted: November 20, 2008
First Posted: November 21, 2008
Results First Submitted: December 8, 2014
Results First Posted: January 16, 2015
Last Update Posted: March 21, 2016