Evaluation of the Safety and Efficacy of Parecoxib in Patients With Subarachnoid Hemorrhage (NCT06579274) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluation of the Safety and Efficacy of Parecoxib in Patients With Subarachnoid Hemorrhage
Czechia112 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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 admini…
What they're measuring
1
Influence of parecoxib on outcome of patients with SAH
Timeframe: 180 days ± 14 days after first dose of parecoxib/placebo
Trial details
NCT IDNCT06579274
SponsorSt. Anne's University Hospital Brno, Czech Republic