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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
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Study Group #1 Study Group #2
Hide Arm/Group Description

Placebo tablet

Placebo: Placebo tablet

Simvastatin 40 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Simvastatin 80 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Period Title: Overall Study
Started 2 12 11
Completed 2 10 7
Not Completed 0 2 4
Arm/Group Title Control Group Study Group #1 Study Group #2 Total
Hide Arm/Group Description

Placebo tablet

Placebo: Placebo tablet

Simvastatin 40 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Simvastatin 80 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Total of all reporting groups
Overall Number of Baseline Participants 2 12 11 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 12 participants 11 participants 25 participants
57  (5.6) 47  (10.7) 50  (11.6) 49  (10.9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 12 participants 11 participants 25 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 12 participants 11 participants 25 participants
Female
2
 100.0%
8
  66.7%
8
  72.7%
18
  72.0%
Male
0
   0.0%
4
  33.3%
3
  27.3%
7
  28.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 12 participants 11 participants 25 participants
Caucasian 1 6 4 11
Black 0 3 4 7
Hispanic 1 3 3 7
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 12 participants 11 participants 25 participants
2 12 11 25
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
Study PI left before outcome data was collected for the study and therefore the Outcome(s) will never be analyzed.
Arm/Group Title Control Group Study Group #1 Study Group #2
Hide Arm/Group Description:

Placebo tablet

Placebo: Placebo tablet

Simvastatin 40 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Simvastatin 80 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 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
Hide Description Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.
Arm/Group Title Control Group Study Group #1 Study Group #2
Hide Arm/Group Description:

Placebo tablet

Placebo: Placebo tablet

Simvastatin 40 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Simvastatin 80 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and Other (Not Including Serious) Adverse Events were not collected/assessed.
 
Arm/Group Title Control Group Study Group #1 Study Group #2
Hide Arm/Group Description

Placebo tablet

Placebo: Placebo tablet

Simvastatin 40 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

Simvastatin 80 mg

Simvastatin: Comparing two doses of Simvastatin to placebo

All-Cause Mortality
Control Group Study Group #1 Study Group #2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Study Group #1 Study Group #2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Group Study Group #1 Study Group #2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Early termination leading to small numbers of subjects analyzed and Primary Physician leaving institution before study completion.
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
Layout table for Results Point of Contact information
Name/Title: Ali Alaraj, MD
Organization: University of Illinois at Chicago
Phone: 312-996-4842
EMail: alaraj@uic.edu
Layout table for additonal information
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