Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579274
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Evaluation of the Safety and Efficacy of Parecoxib in Patients With Subarachnoid Hemorrhage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blind Clinical Trial Evaluating the Safety and Efficacy of Parecoxib in Hospitalized Patients With Spontaneous Subarachnoid Hemorrhage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARISAH
Brief Summary:
Because of the important role of inflammation in the pathophysiology of SAH it was hypothesized that its pharmacological manipulation might improve the prognosis of patients In recent years the effects of several groups of anti-inflammatory drugs on the development of complications after SAH have been described Initially promising glucocorticoids thought to reduce cerebrovascular inflammation brain swelling and headache failed in clinical trials Studies have not provided clear evidence of the beneficial effects of these drugs in patients after SAH Therefore the administration of glucocorticoids is not currently part of the recommended practice In addition glucocorticoid treatment is associated with adverse effects that worsen outcomes including hyperglycemia infection and the risk of gastrointestinal bleeding
Detailed Description:
Spontaneous subarachnoid hemorrhage SAH is a specific type of hemorrhagic stroke with a worldwide incidence ranging from 05 to 28 per 100000 population with large regional variations Despite improvements in diagnosis treatment and care SAH remains a disease with high mortality and morbidity According to the literature one third of patients die within the first few days after SAH and most survivors have cognitive impairment or long-term disability The overall clinical outcome depends on the severity of early brain injury EBI cerebral edema hydrocephalus development of delayed ischemic neurological deficit DIND epileptic seizures and other complications The pathophysiological cascades responsible for the development of these complications remain poorly understood However numerous studies support the important role of aseptic cerebrovascular inflammation induced by blood and blood breakdown products in the subarachnoid space after SAH The increased interest in the development of cerebrovascular inflammation after SAH is confirmed by the increasing number of clinical and experimental studies devoted to this topic Cerebrovascular aseptic inflammation as a potential treatment target is also mentioned in current guidelines for the management of patients after SAH
The results of experimental studies formed the basis for the clinical evaluation of the effects of NSAIDs after SAH The effects of several commonly used NSAIDs particularly dexketoprofen ibuprofen diclofenac indomethacin or dipyrone have been evaluated in prospective and retrospective clinical trials over the past decade In addition to reducing pro-inflammatory markers such as IL6 lowering body temperature and platelet aggregation the administration of NSAIDs has been associated with reduced mortality and improved clinical outcomes Despite the beneficial effects of some NSAIDs more robust studies are still lacking except for one study that evaluated the effect of meloxicam in patients after SAH This study was a randomized double-blind placebo-controlled trial It showed a trend towards a better outcome with a lower incidence of vasospasm or mortality in patients after SAH
Despite encouraging experimental results no clinical trials have yet evaluated the anti-inflammatory and other potentially beneficial effects of cyclooxygenase-2 COX-2 inhibitors COX-2 inhibitors or coxibs belong to the group of NSAIDs that selectively inhibit the COX-2 enzyme which is responsible for developing inflammation and pain A planned clinical study will evaluate the effects of parecoxib a specific COX-2 inhibitor in the NSAIDs group on overall clinical outcome and development of complications in patients following spontaneous SAH
The results of experimental studies formed the basis for the clinical evaluation of the effects of NSAIDs after SAH The effects of several commonly used NSAIDs particularly dexketoprofen ibuprofen diclofenac indomethacin or dipyrone have been evaluated in prospective and retrospective clinical trials over the past decade In addition to reducing pro-inflammatory markers such as IL6 lowering body temperature and platelet aggregation the administration of NSAIDs has been associated with reduced mortality and improved clinical outcomes Despite the beneficial effects of some NSAIDs more robust studies are still lacking except for one study that evaluated the effect of meloxicam in patients after SAH This study was a randomized double-blind placebo-controlled trial It showed a trend towards a better outcome with a lower incidence of vasospasm or mortality in patients after SAH
Despite encouraging experimental results no clinical trials have yet evaluated the anti-inflammatory and other potentially beneficial effects of cyclooxygenase-2 COX-2 inhibitors COX-2 inhibitors or coxibs belong to the group of NSAIDs that selectively inhibit the COX-2 enzyme which is responsible for developing inflammation and pain A planned clinical study will evaluate the effects of parecoxib a specific COX-2 inhibitor in the NSAIDs group on overall clinical outcome and development of complications in patients following spontaneous SAH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None