NCT06579274 Evaluation of the Safety and Efficacy of Parecoxib in Patients With Subarachnoid Hemorrhage
| NCT ID | NCT06579274 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | St. Anne's University Hospital Brno, Czech Republic |
| Condition | Neurological Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 112 participants in total. It began in 2025-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Peter Solar
PRINCIPAL INVESTIGATOR
St. Anne's University Hospital Brno, Czech Republic
Frequently Asked Questions
Who can join the NCT06579274 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Neurological Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06579274 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06579274 currently recruiting?
Yes, NCT06579274 is actively recruiting participants. Contact the research team at lucie.tesarkova@fnusa.cz for enrollment information.
Where is the NCT06579274 trial being conducted?
This trial is being conducted at Brno, Czechia, Olomouc, Czechia, Ostrava, Czechia, Ústí nad Labem, Czechia.
Who is sponsoring the NCT06579274 clinical trial?
NCT06579274 is sponsored by St. Anne's University Hospital Brno, Czech Republic. The principal investigator is Peter Solar at St. Anne's University Hospital Brno, Czech Republic. The trial plans to enroll 112 participants.