File Download

There are no files associated with this item.

  Links for fulltext
     (May Require Subscription)
Supplementary

Article: High-dose simvastatin for aneurysmal subarachnoid hemorrhage: A multicenter, randomized, controlled, double-blind clinical trial protocol

TitleHigh-dose simvastatin for aneurysmal subarachnoid hemorrhage: A multicenter, randomized, controlled, double-blind clinical trial protocol
Authors
KeywordsCerebral aneurysm
Delayed cerebral ischemia
Statin
Stroke
Subarachnoid hemorrhage
Issue Date2013
Citation
Neurosurgery, 2013, v. 72, n. 5, p. 840-844 How to Cite?
AbstractBACKGROUND:: Experimental evidence has indicated the benefit of simvastatin in the treatment of subarachnoid hemorrhage. However, no clinical data are available to answer whether a high-dose regimen is more effective than a normal-dose regimen, even though the biochemical actions and related neuroprotective mechanisms are thought to be dose related. OBJECTIVE:: To determine whether 80 mg simvastatin daily (high dose) over 3 weeks initiated within 96 hours of the ictus will reduce the incidence of delayed ischemic deficits after subarachnoid hemorrhage compared with 40 mg simvastatin daily (normal dose), leading to improvements in clinical outcomes and thus cost-effectiveness. METHODS:: The study design is a randomized, controlled, double-blind clinical trial (www.ClinicalTrials.gov; identifier: NCT01077206). Two hundred forty patients with aneurysmal subarachnoid hemorrhage (presenting within 96 hours of the ictus) from 6 neurosurgical centers are being recruited over 3 years. The primary outcome measure is the presence of delayed ischemic deficits. Secondary outcome measures include modified Rankin Disability Score at 3 months and cost-effectiveness analysis. EXPECTED OUTCOMES:: This will be the first study to clarify whether high-dose simvastatin is better than normal-dose simvastatin for patients with acute aneurysmal subarachnoid hemorrhage in terms of neurological outcomes and cost-effectiveness. DISCUSSION:: In the present trial, we compare high-dose and normal-dose simvastatin; we know that another ongoing phase III multicenter trial (Simvastatin in Aneurysmal Subarachnoid Haemorrhage; http://www.stashtrial.com/home.html) is comparing normal-dose and no simvastatin. When the results are interpreted together, the research question of a possible beneficial effect of high-dose simvastatin in acute aneurysmal subarachnoid hemorrhage could be answered. ABBREVIATIONS:: DID, delayed ischemic deficitCBF, cerebral blood flowSAH, subarachnoid hemorrhage. © 2013 by the Congress of Neurological Surgeons.
Persistent Identifierhttp://hdl.handle.net/10722/325264
ISSN
2023 Impact Factor: 3.9
2023 SCImago Journal Rankings: 1.313
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorWong, George Kwok Chu-
dc.contributor.authorLiang, Min-
dc.contributor.authorTan, Haibin-
dc.contributor.authorLee, Michael Wing Yan-
dc.contributor.authorPo, Yin Chung-
dc.contributor.authorChan, Kwong Yau-
dc.contributor.authorPoon, Wai Sang-
dc.date.accessioned2023-02-27T07:31:04Z-
dc.date.available2023-02-27T07:31:04Z-
dc.date.issued2013-
dc.identifier.citationNeurosurgery, 2013, v. 72, n. 5, p. 840-844-
dc.identifier.issn0148-396X-
dc.identifier.urihttp://hdl.handle.net/10722/325264-
dc.description.abstractBACKGROUND:: Experimental evidence has indicated the benefit of simvastatin in the treatment of subarachnoid hemorrhage. However, no clinical data are available to answer whether a high-dose regimen is more effective than a normal-dose regimen, even though the biochemical actions and related neuroprotective mechanisms are thought to be dose related. OBJECTIVE:: To determine whether 80 mg simvastatin daily (high dose) over 3 weeks initiated within 96 hours of the ictus will reduce the incidence of delayed ischemic deficits after subarachnoid hemorrhage compared with 40 mg simvastatin daily (normal dose), leading to improvements in clinical outcomes and thus cost-effectiveness. METHODS:: The study design is a randomized, controlled, double-blind clinical trial (www.ClinicalTrials.gov; identifier: NCT01077206). Two hundred forty patients with aneurysmal subarachnoid hemorrhage (presenting within 96 hours of the ictus) from 6 neurosurgical centers are being recruited over 3 years. The primary outcome measure is the presence of delayed ischemic deficits. Secondary outcome measures include modified Rankin Disability Score at 3 months and cost-effectiveness analysis. EXPECTED OUTCOMES:: This will be the first study to clarify whether high-dose simvastatin is better than normal-dose simvastatin for patients with acute aneurysmal subarachnoid hemorrhage in terms of neurological outcomes and cost-effectiveness. DISCUSSION:: In the present trial, we compare high-dose and normal-dose simvastatin; we know that another ongoing phase III multicenter trial (Simvastatin in Aneurysmal Subarachnoid Haemorrhage; http://www.stashtrial.com/home.html) is comparing normal-dose and no simvastatin. When the results are interpreted together, the research question of a possible beneficial effect of high-dose simvastatin in acute aneurysmal subarachnoid hemorrhage could be answered. ABBREVIATIONS:: DID, delayed ischemic deficitCBF, cerebral blood flowSAH, subarachnoid hemorrhage. © 2013 by the Congress of Neurological Surgeons.-
dc.languageeng-
dc.relation.ispartofNeurosurgery-
dc.subjectCerebral aneurysm-
dc.subjectDelayed cerebral ischemia-
dc.subjectStatin-
dc.subjectStroke-
dc.subjectSubarachnoid hemorrhage-
dc.titleHigh-dose simvastatin for aneurysmal subarachnoid hemorrhage: A multicenter, randomized, controlled, double-blind clinical trial protocol-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1227/NEU.0b013e31828ab413-
dc.identifier.pmid23392270-
dc.identifier.scopuseid_2-s2.0-84876717187-
dc.identifier.volume72-
dc.identifier.issue5-
dc.identifier.spage840-
dc.identifier.epage844-
dc.identifier.isiWOS:000317915100035-

Export via OAI-PMH Interface in XML Formats


OR


Export to Other Non-XML Formats