Parecoxib for safety and effectiveness after subarachnoid hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial investigates parecoxib, an NSAID, versus placebo in adults with spontaneous SAH. The aim is to see if parecoxib can reduce inflammation-related complications and improve outcomes after SAH. Participants are adults aged 18–85 with CT-confirmed SAH treated within 48 hours, and the study compares parecoxib to placebo in addition to standard care. The trial emphasizes safety monitoring and collects data on clinical status, adverse events, and neurological outcomes. Enrollment involves informed consent and strict eligibility criteria across multiple Czech centers.

Why it matters

Who can join: the full rules

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).

Where it's running

• St. Anne's University Hospital Brno
  Brno, Czech Republic, Czechia Recruiting
• University Hospital Olomouc
  Olomouc, Czechia Recruiting
• University Hospital Ostrava
  Ostrava, Czechia Recruiting
• Masarykovy nemocnice v Ústí nad Labem, o.z.
  Ústí nad Labem, Czechia Recruiting

Study contacts

• Principal investigator: Peter Solar — St. Anne's University Hospital Brno, Czech Republic
• Study coordinator: Lucie Tesárková
• Email: lucie.tesarkova@fnusa.cz
• Phone: +420 543 185 174

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.