Status:
NOT_YET_RECRUITING
Evaluation of the Safety and Efficacy of Parecoxib in Patients With Subarachnoid Hemorrhage
Lead Sponsor:
St. Anne's University Hospital Brno, Czech Republic
Collaborating Sponsors:
Masaryk University
CZECRIN - Czech Clinical Research Infrastructure Network
Conditions:
Neurological Complication
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 eff...
Detailed Description
Spontaneous subarachnoid hemorrhage (SAH) is a specific type of hemorrhagic stroke with a worldwide incidence ranging from 0.5 to 28 per 100,000 population, with large regional variations. Despite imp...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06579274
Start Date
January 1 2025
End Date
July 1 2027
Last Update
August 30 2024
Active Locations (1)
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1
St. Anne's University Hospital Brno
Brno, Czech Republic, Czechia, 602 00