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NCT06579274

PHASE2

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

Sponsor: St. Anne's University Hospital Brno, Czech Republic

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2025-01-01

Completion Date

2027-07-01

Last Updated

2024-08-30

Healthy Volunteers

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.

Inclusion Criteria: * Signed informed consent * Age: 18-85 years * Weight\> 50 kg * Spontaneous SAH diagnosed on a native CT brain max. 48 hours after the first symptoms * Spontaneous SAH caused by rupture of the cerebral aneurysm confirmed on DSA or CT angiography (Fisher grade 1 to 4) OR Spontaneous SAH without a source on CT AG, DSA or MRI with Fisher grade 3 and 4 * For women capable of becoming pregnant (see definitions from the CTFG guideline for contraception): use of the following highly reliable contraceptive method within 3 months after the end of the study: adherence to sexual abstinence or contraception containing progesterone with inhibition of ovulation (oral administration, injection) or non-hormonal intrauterine device or hormonal or bilateral tubal occlusion or partner vasectomy. Males: adherence to sexual abstinence or use of an adequate contraceptive method (i.e. condom) in case of sexual intercourse within 3 months after the end of the study. Exclusion Criteria: * Symptoms of SAH without the finding of blood on the initial native CT scan of the brain * SAH from a cause other than a ruptured aneurysm, e.g. A-V malformation, traumatic SAH * Pregnancy and breastfeeding (pregnancy test) * Known hypersensitivity to the components of the product * Allergic reaction to the active substance or sulfonamides in the anamnesis * Concomitant treatment with other non-steroidal anti-inflammatory drugs, aspirin or corticosteroids (at least five half-lives before administration of the medicinal product under investigation) * Severe hepatic insufficiency (serum albumin level \<25 g/l or Child-Pugh score less than 10). * Active peptic ulcer or bleeding from the gastrointestinal tract in the anamnesis * Inflammatory bowel disease in the anamnesis * Congestive heart failure (NYHA II-IV) in history. * Proven ischemic heart disease, peripheral arterial insufficiency. * Participation in another clinical study (a gap of at least five half-lives before administration of the medicinal product under investigation).

Locations (1)

St. Anne's University Hospital Brno

Brno, Czech Republic, Czechia