Trial Outcomes & Findings for Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH) (NCT NCT00795288)
NCT ID: NCT00795288
Last Updated: 2016-03-21
Results Overview
Resting cerebral blood flow during peak period of vasospasm risk measured by PET
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
42 participants
Primary outcome timeframe
7-10 days after hemorrhage
Results posted on
2016-03-21
Participant Flow
Participant milestones
| Measure |
Placebo
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.
|
Simvastatin
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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)
Baseline characteristics by cohort
| Measure |
Simvastatin
n=21 Participants
Simvastatin, 80 mg/day
Simvastatin, 80 mg/day for 21 days: Active treatment group
|
Control
n=21 Participants
placebo: Control group
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 12 • n=99 Participants
|
60 years
STANDARD_DEVIATION 10 • n=107 Participants
|
60 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
21 participants
n=107 Participants
|
42 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7-10 days after hemorrhagePopulation: 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
Resting cerebral blood flow during peak period of vasospasm risk measured by PET
Outcome measures
| Measure |
Simvastatin
n=13 Participants
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.
|
Control
n=12 Participants
placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
|
|---|---|---|
|
Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk
|
.34 mL/100 g/min
Standard Deviation 0.1
|
.30 mL/100 g/min
Standard Deviation .18
|
PRIMARY outcome
Timeframe: 7-10 days after hemorrhageFraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) \* 100 A value of \<60 is considered abnormal.
Outcome measures
| Measure |
Simvastatin
n=13 Participants
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.
|
Control
n=12 Participants
placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
|
|---|---|---|
|
Cerebral Autoregulation During Peak Period of Vasospasm Risk
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 7-10 days after hemorrhageOxygen 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.
Outcome measures
| Measure |
Simvastatin
n=13 Participants
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.
|
Control
n=12 Participants
placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
|
|---|---|---|
|
Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk
|
.34 ratio
Standard Deviation .1
|
.3 ratio
Standard Deviation .18
|
Adverse Events
Simvastatin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place