RecruitingPhase 2NCT06579274

Evaluation of the Safety and Efficacy of Parecoxib in Patients With Subarachnoid Hemorrhage

A Randomized, Placebo-controlled, Double-blind Clinical Trial Evaluating the Safety and Efficacy of Parecoxib in Hospitalized Patients With Spontaneous Subarachnoid Hemorrhage


Sponsor

St. Anne's University Hospital Brno, Czech Republic

Enrollment

112 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Parecoxib and a drug called Placebo for people with neurological complication. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGParecoxib

Parecoxib (Dynastat) 40 mg solution for injection is for intravenous administration. Parecoxib may be given as an intravenous injection for 30 minutes directly into a vein or through an intravenous infusion set.

DRUGPlacebo

Placebo intravenous injection can be administered quickly and directly into a vein or through an intravenous infusion set.


Locations(4)

St. Anne's University Hospital Brno

Brno, Czech Republic, Czechia

University Hospital Olomouc

Olomouc, Czechia

University Hospital Ostrava

Ostrava, Czechia

Masarykovy nemocnice v Ústí nad Labem, o.z.

Ústí nad Labem, Czechia

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NCT06579274


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