Trial record 13 of 680 for:
Open Studies | "Hemorrhage"
Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Washington University School of Medicine.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Washington University School of Medicine
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00795288
First received: November 20, 2008
Last updated: March 2, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Subarachnoid Hemorrhage |
Drug: Simvastatin, 80 mg/day for 21 days Drug: placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- Resting cerebral blood flow during peak period of vasospasm risk [ Time Frame: 7-10 days after hemorrhage ] [ Designated as safety issue: No ]
- Cerebral autoregulation during peak period of vasospasm risk [ Time Frame: 7-10 days after hemorrhage ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Impact of statin on oxygen extraction fraction and cerebral metabolism during peak period of vasospasm risk [ Time Frame: 7-10 days after hemorrhage ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Simvastatin, 80 mg/day
|
Drug: Simvastatin, 80 mg/day for 21 days
Active treatment group
|
| Placebo Comparator: 2 |
Drug: placebo
Control group
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18
- SAH from ruptured cerebral aneurysm within 48 hours of admission.
- Modified Fisher grade 2,3,or 4
- Planned surgical or endovascular aneurysm repair
Exclusion Criteria:
- Pregnancy
- SAH secondary to traumatic or mycotic aneurysms
- Pre-ictal statin therapy
- Contraindication to stain therapy
- WFNS grade 5
- Contraindications to MAP elevation on day 7-10
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795288
Contacts
| Contact: Abbie Bradley, RN | (314) 747-8882 | bradleya@nsurg.wustl.edu |
Locations
| United States, Missouri | |
| Washington Univeristy | Recruiting |
| ST Louis, Missouri, United States, 63110 | |
| Contact: Michael N Diringer, md 314-362-2999 DIRINGERM@WUSTL.EDU | |
| Sub-Investigator: Greg Zipfel, MD | |
| Sub-Investigator: Colin Derdeyn, MD | |
Sponsors and Collaborators
Washington University School of Medicine
Investigators
| Principal Investigator: | Michael Diringer, MD | Washington University School of Medicine |
More Information
No publications provided
| Responsible Party: | Michael Diringer, MD, Washington Univeristy |
| ClinicalTrials.gov Identifier: | NCT00795288 History of Changes |
| Other Study ID Numbers: | 3857 - 54118B, 1P50NS05597701A2 |
| Study First Received: | November 20, 2008 |
| Last Updated: | March 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
subarachnoid hemorrhage vasospasm cerebral blood flow cerebral metabolism |
autoregulation statin Vasospasm associated with Subarachnoid hemorrhage |
Additional relevant MeSH terms:
|
Hemorrhage Subarachnoid Hemorrhage Intracranial Hemorrhages Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Simvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013