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The primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design.
We will determine if statin therapy improves CBF in patients with aneurysmal subarachnoid hemorrhage. This improvement, if present, may be due to improved basal CBF, improved autoregulatory function, or a mitigation of large arterial narrowing. The information gain from this study will help us to better understand the mechanism of action of statins. This knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin, 80 mg/day | Experimental | Simvastatin, 80 mg/day for 21 days |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin, 80 mg/day for 21 days | Drug | Active treatment group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk | Resting cerebral blood flow during peak period of vasospasm risk measured by PET | 7-10 days after hemorrhage |
| Cerebral Autoregulation During Peak Period of Vasospasm Risk | Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal. | 7-10 days after hemorrhage |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk | Oxygen 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. | 7-10 days after hemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Diringer, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Univeristy | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26721259 | Result | Diringer MN, Dhar R, Scalfani M, Zazulia AR, Chicoine M, Powers WJ, Derdeyn CP. Effect of High-Dose Simvastatin on Cerebral Blood Flow and Static Autoregulation in Subarachnoid Hemorrhage. Neurocrit Care. 2016 Aug;25(1):56-63. doi: 10.1007/s12028-015-0233-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Simvastatin | Simvastatin, 80 mg/day Simvastatin, 80 mg/day for 21 days: Active treatment group |
| BG001 | Control | placebo: Control group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk | Resting cerebral blood flow during peak period of vasospasm risk measured by PET | 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 | Posted | Mean | Standard Deviation | mL/100 g/min | 7-10 days after hemorrhage |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simvastatin | Simvastatin, 80 mg/day Simvastatin, 80 mg/day for 21 days: Active treatment group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Diringer | Washington University | 314-362-2999 | diringerm@wustl.edu |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| placebo | Drug | Control group |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Control |
placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage. |
|
|
| Primary | Cerebral Autoregulation During Peak Period of Vasospasm Risk | Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal. | Posted | Number | participants | 7-10 days after hemorrhage |
|
|
|
| Secondary | Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk | Oxygen 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. | Posted | Mean | Standard Deviation | ratio | 7-10 days after hemorrhage |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Control | placebo: Control group | 0 | 21 | 0 | 21 |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |