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Trial Outcomes & Findings for Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage (NCT NCT00487461)

NCT ID: NCT00487461

Last Updated: 2015-11-25

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

21 days

Results posted on

2015-11-25

Participant Flow

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
2
12
11
Overall Study
COMPLETED
2
10
7
Overall Study
NOT COMPLETED
0
2
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group
n=2 Participants
Placebo tablet Placebo: Placebo tablet
Study Group #1
n=12 Participants
Simvastatin 40 mg Simvastatin: Comparing two doses of Simvastatin to placebo
Study Group #2
n=11 Participants
Simvastatin 80 mg Simvastatin: Comparing two doses of Simvastatin to placebo
Total
n=25 Participants
Total of all reporting groups
Age, Continuous
57 years
STANDARD_DEVIATION 5.6 • n=99 Participants
47 years
STANDARD_DEVIATION 10.7 • n=107 Participants
50 years
STANDARD_DEVIATION 11.6 • n=206 Participants
49 years
STANDARD_DEVIATION 10.9 • n=7 Participants
Age, Customized
> 70 years
0 participants
n=99 Participants
1 participants
n=107 Participants
2 participants
n=206 Participants
3 participants
n=7 Participants
Age, Customized
60-70 years
1 participants
n=99 Participants
0 participants
n=107 Participants
1 participants
n=206 Participants
2 participants
n=7 Participants
Age, Customized
50-60 years
1 participants
n=99 Participants
3 participants
n=107 Participants
3 participants
n=206 Participants
7 participants
n=7 Participants
Age, Customized
40-50 years
0 participants
n=99 Participants
6 participants
n=107 Participants
4 participants
n=206 Participants
10 participants
n=7 Participants
Age, Customized
< 40 years
0 participants
n=99 Participants
2 participants
n=107 Participants
1 participants
n=206 Participants
3 participants
n=7 Participants
Sex: Female, Male
Female
2 Participants
n=99 Participants
8 Participants
n=107 Participants
8 Participants
n=206 Participants
18 Participants
n=7 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
4 Participants
n=107 Participants
3 Participants
n=206 Participants
7 Participants
n=7 Participants
Race/Ethnicity, Customized
Caucasian
1 participants
n=99 Participants
6 participants
n=107 Participants
4 participants
n=206 Participants
11 participants
n=7 Participants
Race/Ethnicity, Customized
Black
0 participants
n=99 Participants
3 participants
n=107 Participants
4 participants
n=206 Participants
7 participants
n=7 Participants
Race/Ethnicity, Customized
Hispanic
1 participants
n=99 Participants
3 participants
n=107 Participants
3 participants
n=206 Participants
7 participants
n=7 Participants
Region of Enrollment
United States
2 participants
n=99 Participants
12 participants
n=107 Participants
11 participants
n=206 Participants
25 participants
n=7 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Study PI left before outcome data was collected for the study and therefore the Outcome(s) will never be analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Study Group #1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Study Group #2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ali Alaraj, MD

University of Illinois at Chicago

Phone: 312-996-4842

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place