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Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

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

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
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Simvastatin
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 21 21
Completed 21 21
Not Completed 0 0
Arm/Group Title Simvastatin Control Total
Hide Arm/Group Description

Simvastatin, 80 mg/day

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

placebo: Control group Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
21
 100.0%
42
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
59  (12) 60  (10) 60  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
12
  57.1%
14
  66.7%
26
  61.9%
Male
9
  42.9%
7
  33.3%
16
  38.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   9.5%
3
  14.3%
5
  11.9%
White
19
  90.5%
18
  85.7%
37
  88.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 21 participants 42 participants
21 21 42
1.Primary Outcome
Title Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk
Hide Description Resting cerebral blood flow during peak period of vasospasm risk measured by PET
Time Frame 7-10 days after hemorrhage
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Of the total population enrolled complete data sets were available on 25. This was due to patient refusal to perform the PET study, logistical difficulties and technical problems.

be completed in seven due to logistical difficulties (n = 4) or patient refusal (n = 3). Two of the completed studies could not be analyzed for technical reasons

Arm/Group Title Simvastatin Control
Hide Arm/Group Description:
Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: mL/100 g/min
.34  (0.1) .30  (.18)
2.Primary Outcome
Title Cerebral Autoregulation During Peak Period of Vasospasm Risk
Hide Description Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.
Time Frame 7-10 days after hemorrhage
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Control
Hide Arm/Group Description:
Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
Overall Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: participants
2 2
3.Secondary Outcome
Title Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk
Hide Description Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.
Time Frame 7-10 days after hemorrhage
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin, 80 mg/Day Placebo
Hide Arm/Group Description:

Simvastatin, 80 mg/day for 21 days

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

Placebo

placebo: Control group

Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: ratio
.34  (.1) .3  (.18)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simvastatin Control
Hide Arm/Group Description

Simvastatin, 80 mg/day

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

placebo: Control group
All-Cause Mortality
Simvastatin Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Simvastatin Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Simvastatin Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
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
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