The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Sao Paulo General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Sao Paulo General Hospital
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01346748
First received: April 27, 2011
Last updated: May 2, 2011
Last verified: April 2011
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Purpose
Delayed ischemia caused by cerebral vasospasm remains a common cause of morbidity and mortality after aneurysmal subarachnoid hemorrhage. A great deal of drugs has been tested in the last years. Phase II randomized clinical trials have demonstrated that statin decreases the incidence of symptomatic cerebral vasospasm after spontaneous subarachnoid hemorrhage. Clinical, double blind, randomized controlled trials with placebo. Discussion: Even though some articles have shown that statins provide better prognosis, some issues remain in debate, e.g., treatment duration and the choice of the statin.
| Condition | Intervention | Phase |
|---|---|---|
|
Aneurysmal Subarachnoid Hemorrhage |
Drug: statin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo General Hospital:
Primary Outcome Measures:
- The role of statins in preventing cerebral vasospasm secondary to subarachnoid hemorrhage [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Diference in clinical outcome between patients who will or won't receive sinvastatin.
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Statin |
Drug: statin
Sinvastatin 80 mg per day - 21 days versus placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age between 18 and 65 years old, Hunt-hess scale < 3
Exclusion Criteria:
- Liver disfunction, previous use of statin, hunt-hess scale 4 or 5.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346748
Contacts
| Contact: Flavio Romero | 11-34594416 | frromero@ig.com.br |
| Contact: Flávio Romero | 11-34594416 | frromero@ig.com.br |
Locations
| Brazil | |
| Hospital das Clínicas | Recruiting |
| São Paulo, Brazil, 05445-000 | |
| Contact: Flávio Romero 11-34594416 frromero@ig.com.br | |
| Principal Investigator: Eberval Figueiredo | |
| Principal Investigator: Flavio Romero | |
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
| Principal Investigator: | Eberval Figueiredo, PhD | University of São Paulo |
More Information
No publications provided
| Responsible Party: | Eberval Gadelha Figueiredo, Neurology department of São Paulo University |
| ClinicalTrials.gov Identifier: | NCT01346748 History of Changes |
| Other Study ID Numbers: | 1268/09 |
| Study First Received: | April 27, 2011 |
| Last Updated: | May 2, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo General Hospital:
|
vasospasm prevention |
Additional relevant MeSH terms:
|
Hemorrhage Subarachnoid Hemorrhage Vasospasm, Intracranial Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013