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A randomized, placebo-controlled, double-blind clinical trial evaluating the safety and efficacy of parecoxib in hospitalized patients with spontaneous subarachnoid hemorrhage
EU CTIS ID: 2024-519436-17-00
What this study is testing
The primary endpoint is the percentage of patients in the experimental and placebo groups whose clinical outcome according to the modified Rankin Scale (mRS) is graded as favorable (mRS 0-3) or unfavorable (mRS 4-6) 6 months after the first dose of the investigational drug/placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent.
- Age: 18-85 years
- Weight > 50 kg.
- Spontaneous SAH diagnosed on native brain CT within 48 hours of first symptoms due to rupture of a bulge in one of the cerebral arteries confirmed by on DSA or CT angiography (Fisher grade 1 to 4) OR Spontaneous SAH without source by CT AG, DSA or MRI with Fisher grade 3 and 4.
- For women capable of becoming pregnant (see definition from CTFG contraceptive guidelines): use of the following highly reliable contraceptive method within 3 months of study completion: adherence to sexual abstinence or progesterone-containing contraceptives with ovulation inhibition (oral administration, injection) or intrauterine device non-hormonal or hormonal or bilateral tubal occlusion or partner vasectomy. Men: adherence to sexual abstinence or use of an adequate contraceptive method (i.e., condom) in the event of sexual intercourse within 3 months of study completion.
You likely can't join if
- Symptoms of SAH without blood findings on the initial native CT scan of the brain.
- Severe hepatic insufficiency (serum albumin level <25 g /l or Child-Pugh score 10).
- History of active peptic ulcer or gastrointestinal bleeding.
- History of inflammatory bowel disease.
- Systolic blood pressure ≥ 160 mmHg.
- History of congestive heart failure (NYHA II-IV).
See the full eligibility criteria
- Signed informed consent.
- Age: 18-85 years
- Weight > 50 kg.
- Spontaneous SAH diagnosed on native brain CT within 48 hours of first symptoms due to rupture of a bulge in one of the cerebral arteries confirmed by on DSA or CT angiography (Fisher grade 1 to 4) OR Spontaneous SAH without source by CT AG, DSA or MRI with Fisher grade 3 and 4.
- For women capable of becoming pregnant (see definition from CTFG contraceptive guidelines): use of the following highly reliable contraceptive method within 3 months of study completion: adherence to sexual abstinence or progesterone-containing contraceptives with ovulation inhibition (oral administration, injection) or intrauterine device non-hormonal or hormonal or bilateral tubal occlusion or partner vasectomy. Men: adherence to sexual abstinence or use of an adequate contraceptive method (i.e., condom) in the event of sexual intercourse within 3 months of study completion.
- Symptoms of SAH without blood findings on the initial native CT scan of the brain.
- Severe hepatic insufficiency (serum albumin level <25 g /l or Child-Pugh score 10).
- History of active peptic ulcer or gastrointestinal bleeding.
- History of inflammatory bowel disease.
- Systolic blood pressure ≥ 160 mmHg.
- History of congestive heart failure (NYHA II-IV).
- History of coronary artery disease, peripheral arterial insufficiency.
- Participation in another clinical trial (at least 5 half-lives apart before administration of the investigational medicinal product).
- SAH due to a cause other than ruptured aneurysm, e.g. A-V malformation, traumatic SAH.
- Pregnancy and breastfeeding (pregnancy test).
- Known hypersensitivity to the components of the product.
- History of allergic reaction to the active substance or to sulfonamides.
- Concomitant treatment with another non-steroidal anti-inflammatory drug, aspirin or corticosteroids (at least 5 half-lives apart before administration of the investigational medicinal product).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.