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

NCT06579274 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-08-30

No results posted yet for this study

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.

Conditions

  • Neurological Complication

Interventions

DRUG

Parecoxib

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Masaryk University

    collaborator OTHER

  • CZECRIN - Czech Clinical Research Infrastructure Network

    collaborator UNKNOWN

  • St. Anne's University Hospital Brno, Czech Republic

    lead OTHER

Principal Investigators

  • Peter Solar · St. Anne´s University Hospital Brno

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-01-01
Completion
2027-07-01

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579274 on ClinicalTrials.gov