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

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=5 Participants	47 years STANDARD_DEVIATION 10.7 • n=7 Participants	50 years STANDARD_DEVIATION 11.6 • n=5 Participants	49 years STANDARD_DEVIATION 10.9 • n=4 Participants
Age, Customized > 70 years	0 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	3 participants n=4 Participants
Age, Customized 60-70 years	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Age, Customized 50-60 years	1 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	7 participants n=4 Participants
Age, Customized 40-50 years	0 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	10 participants n=4 Participants
Age, Customized < 40 years	0 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	1 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	11 participants n=4 Participants
Race/Ethnicity, Customized Black	0 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	7 participants n=4 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	7 participants n=4 Participants
Region of Enrollment United States	2 participants n=5 Participants	12 participants n=7 Participants	11 participants n=5 Participants	25 participants n=4 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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place