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Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage

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ClinicalTrials.gov Identifier: NCT00487461
Recruitment Status : Terminated (Study PI left the institution and study was stopped at that time.)
First Posted : June 18, 2007
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Ali Alaraj, University of Illinois at Chicago

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Aneurysmal Subarachnoid Hemorrhage
Cerebral Vasospasm
Interventions: Drug: Simvastatin 40 mg
Drug: Placebo
Drug: Simvastatin 80 mg

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Group

Placebo tablet

Placebo: Placebo tablet

Study Group #1

Simvastatin 40 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Study Group #2

Simvastatin 80 mg

Simvastatin: Comparing two doses of Simvastatin to placebo


Participant Flow:   Overall Study
    Control Group   Study Group #1   Study Group #2
STARTED   2   12   11 
COMPLETED   2   10   7 
NOT COMPLETED   0   2   4 



  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
  Description
Control Group

Placebo tablet

Placebo: Placebo tablet

Study Group #1

Simvastatin 40 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Study Group #2

Simvastatin 80 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Total Total of all reporting groups

Baseline Measures
   Control Group   Study Group #1   Study Group #2   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   12   11   25 
Age 
[Units: Years]
Median (Standard Deviation)
 57  (5.6)   47  (10.7)   50  (11.6)   49  (10.9) 
Age, Customized 
[Units: Participants]
       
> 70 years   0   1   2   3 
60-70 years   1   0   1   2 
50-60 years   1   3   3   7 
40-50 years   0   6   4   10 
< 40 years   0   2   1   3 
Gender 
[Units: Participants]
       
Female   2   8   8   18 
Male   0   4   3   7 
Race/Ethnicity, Customized 
[Units: Participants]
       
Caucasian   1   6   4   11 
Black   0   3   4   7 
Hispanic   1   3   3   7 
Region of Enrollment 
[Units: Participants]
       
United States   2   12   11   25 


  Outcome Measures

1.  Primary:   To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH   [ Time Frame: 21 days ]

2.  Secondary:   To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up   [ Time Frame: 6 months ]


  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
Early termination leading to small numbers of subjects analyzed and Primary Physician leaving institution before study completion.


  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: Ali Alaraj, MD
Organization: University of Illinois at Chicago
phone: 312-996-4842
e-mail: alaraj@uic.edu



Responsible Party: Ali Alaraj, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00487461     History of Changes
Other Study ID Numbers: 2005-0857
First Submitted: June 15, 2007
First Posted: June 18, 2007
Results First Submitted: July 22, 2015
Results First Posted: November 25, 2015
Last Update Posted: November 25, 2015