A Phase 2 interventional study of Parecoxib and Placebo in Neurological Complication, sponsored by St. Anne's University Hospital Brno, Czech Republic. Recruiting at 4 sites in Czechia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by St. Anne's University Hospital Brno, Czech Republic · Phase 2, Interventional, and Treatment
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.
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 improvements in diagnosis, treatment and care, SAH remains a disease with high mortality and morbidity. According to the literature, one third of patients die within the first few days after SAH, and most survivors have cognitive impairment or long-term disability. The overall clinical outcome depends on the severity of early brain injury (EBI), cerebral edema, hydrocephalus, development of delayed ischemic neurological deficit (DIND), epileptic seizures, and other complications. The pathophysiological cascades responsible for the development of these complications remain poorly understood. However, numerous studies support the important role of aseptic cerebrovascular inflammation induced by blood and blood breakdown products in the subarachnoid space after SAH. The increased interest in the development of cerebrovascular inflammation after SAH is confirmed by the increasing number of clinical and experimental studies devoted to this topic. Cerebrovascular aseptic inflammation as a potential treatment target is also mentioned in current guidelines for the management of patients after SAH.
The results of experimental studies formed the basis for the clinical evaluation of the effects of NSAIDs after SAH. The effects of several commonly used NSAIDs, particularly dexketoprofen, ibuprofen, diclofenac, indomethacin, or dipyrone, have been evaluated in prospective and retrospective clinical trials over the past decade. In addition to reducing pro-inflammatory markers such as IL6, lowering body temperature and platelet aggregation, the administration of NSAIDs has been associated with reduced mortality and improved clinical outcomes. Despite the beneficial effects of some NSAIDs, more robust studies are still lacking, except for one study that evaluated the effect of meloxicam in patients after SAH. This study was a randomized, double-blind, placebo-controlled trial. It showed a trend towards a better outcome with a lower incidence of vasospasm or mortality in patients after SAH.
Despite encouraging experimental results, no clinical trials have yet evaluated the anti-inflammatory and other potentially beneficial effects of cyclooxygenase-2 (COX-2) inhibitors. COX-2 inhibitors, or coxibs, belong to the group of NSAIDs that selectively inhibit the COX-2 enzyme, which is responsible for developing inflammation and pain. A planned clinical study will evaluate the effects of parecoxib, a specific COX-2 inhibitor in the NSAIDs group, on overall clinical outcome and development of complications in patients following spontaneous SAH.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's planned enrollment of 112 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →St. Anne's University Hospital Brno, Czech Republic is the lead sponsor of 25 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Parecoxib 40 mg/100 ml will be injected into a peripheral or central venous catheter within 12 hours of the patient's inclusion in the study (from when informed consent is signed). Parecoxib 40 mg/100 ml is administered every 12 hours for 5 days. The maximum daily dose is 80 mg. In patients with moderate hepatic impairment (Child-Pugh score 7-9), parecoxib is started at 20 mg/50 mL and continued at this dose every 12 hours. The maximum daily dose is 40 mg. Participants will be monitored for six months for adverse events and changes in subjective status. In the event of adverse events, patients will be followed until resolution. After that, their participation in this clinical trial will be terminated. The total duration of the patient's participation in the clinical trial will be six months.
Drug: Parecoxib
A placebo is a substance administered to a participant as a comparison without any pharmacological effect. However, unlike conventional medicines, it does not contain any active ingredients. In this clinical trial, the placebo is an isotonic sodium chloride solution. The placebo is injected into a peripheral or central venous catheter within 12 hours of the patient's enrollment in the study (from when informed consent is signed). Placebo 100 mL per dose will continue to be administered every 12 hours for five days. Participants will be followed for six months for any adverse events and changes in subjective status. In the event of adverse effects, patients will be followed until resolution. After that, their participation in this clinical trial will be terminated. The total duration of the patient's participation in the clinical trial will be six months.
Drug: Placebo
Parecoxib (Dynastat) 40 mg solution for injection is for intravenous administration. Parecoxib may be given as an intravenous injection for 30 minutes directly into a vein or through an intravenous infusion set.
Placebo intravenous injection can be administered quickly and directly into a vein or through an intravenous infusion set.
Influence of parecoxib on outcome of patients with SAH
The primary outcome measure is the percentage of patients in the active and control groups whose outcome is categorized as favorable (mRS 0-3) or unfavorable (mRS 4-6) according to the modified Rankin Scale (mRS).
Time frame: 180 days ± 14 days after first dose of parecoxib/placebo
Influence of parecoxib on outcome of patients with SAH
The secondary monitored parameter is the percentage of patients in the active and control groups whose outcome, according to the modified Rankin scale (mRS), is divided into favourable (mRS 0-3) or unfavourable (mRS 4-6).
Time frame: Discharge from hospital and 90 days ± 7 days after first dose of parecoxib/placebo
Occurrence of symptomatic vasospasms (vasospasms confirmed on TCD / CT AG / MR AG / DSA
Number of patients with vasospasms confirmed on TCD / CT AG / MR AG / DSA
Time frame: Six, eight and ten days after the application of the first dose of the evaluated medicinal product /placebo.
Incidence of delayed ischemic neurological deficit (DIND)
Number of patients with delayed ischemic neurological deficit
Time frame: Six, eight and ten days, three and six months after the application of the first dose of the evaluated medicinal product /placebo.
Mortality
Number of deaths
Time frame: During the treatment and post treatment period of hospitalization, 90 days ± 7 days and 180 days ± 14 days
Length of hospitalization in ICU
Length of hospitalization in ICU
Time frame: 3 months
Total length of hospitalization
Total length of hospitalization
Time frame: 3 months
Occurrence of acute hydrocephalus
Number of patients with acute hydrocephalus
Time frame: During the treatment and post treatment period of hospitalization
Occurrence of chronic hydrocephalus
Number of patients with chronic hydrocephalus with V-P shunt implantation
Time frame: During the treatment and post treatment period of hospitalization, 90 days ± 7 days, 180 days ± 14 days
Occurrence of fevers
Number of patients with fever above 38 degrees Celsius
Time frame: During the treatment and post treatment period of hospitalization
Occurrence of inflammation
Evaluation of the systemic inflammatory response (assessed daily during hospitalization) meeting at least 2 parameters: * heart rate \> 90/min. * leukocytosis \> 12x109/l) or leukopenia \< 9x109 * respiratory rate \> 20/min. or PaCO2 \< 32 mm Hg (4.3 kPa) * body temperature \< 36.0 °C or \> 38.0 °C
Time frame: During the treatment and post treatment period of hospitalization
Evaluation of pain according to Visual Analogue Scale
The comparison of the patients in the treatment and placebo arm with pain according to the Visual Analogue Scale, a numerical scale from 0 to 10 points, where increasing pain is indicated by a higher score.
Time frame: During the treatment and post treatment period of hospitalization, discharge from hospital, 90 days ± 7 days and 180 days ± 14 days after first dose of parecoxib/placebo
Evaluation of prostaglandins and pro-inflammatory cytokines in the cerebrospinal fluid in the case of the below-mentioned external ventricular drainage after 2 days and in the serum
Evaluation of prostaglandins (COX-2, PGH2, PGI2, PGE2, PGD2, PF2a, TXA2) and pro-inflammatory cytokines (TNF, IL-1, IL-4, IL-6, IL-8, IL-12) in the cerebrospinal fluid in the case of the below-mentioned external ventricular drainage after 2 days and in the serum regardless of the established cerebrospinal fluid drainage after two days to day 10 from initial symptoms
Time frame: 0, 2, 4, 6, 8 and 10 days after implantation of drainage
Evaluatioon of laboratory markers of inflammatory response in peripheral blood
C-reactive protein (CRP), procalcitonin (PCT) and white blood cell count
Time frame: Two, four, six, eight and ten days after the application of the first dose parecoxib/placebo
Evaluation of the functionality of the blood-cerebrospinal fluid barrier every 2 days if cerebrospinal fluid drainage is necessary.
This evaluation will compare the number of patients in the treatment and placebo arms who undergo cerebrospinal fluid drainage.
Time frame: 0, 2, 4, 6, 8 and 10 days after implantation of drainage
Quality of life measured through questionnaires
Evaluation of quality of life (SF-36 score)
Time frame: Discharge from hospital, 90 days ± 7 days and 180 days ± 14 days after the application of the first dose parecoxib/placebo
Evaluation of the difference in efficacy parameters between subgroups according to the source of bleeding
Number of patients with inflamation based on source of bleeding
Time frame: After discharge from hospital, six days after administration of the 1st dose of parecoxib/placebo
Serious adverse events
Percentage of patients in the experimental and placebo groups with the occurrence of serious adverse events (SAE) (assessed during hospitalization, at discharge, 3 and 6 months after the first dose) supplemented by evaluation in individual subgroups according to the source of bleeding.
Time frame: During hospitalization, at discharge, 90 days ± 7 days, 180 days ± 14 days after the first dose of parecoxib/placebo
Hepatotoxicity
Percentage of patients in the experimental and placebo groups with an increase in blood creatine phosphokinase (CPK), an increase in blood lactate dehydrogenase (LDH), an increase in alanine transaminase (ALT), an increase in aspartate transaminase (AST), and an increase in blood urea level \> 5x ULN; separate analysis for subgroups by source of bleeding.
Time frame: Before the 1st dose of parecoxib/placebo, 1., 3. and 5. day of treatment and 10. day of hospitalization
Plan to share: No
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Started Jan 2025 (actual). Primary completion is estimated for Jan 2027, 24 months after the start.
Of 113 non-industry phase 2 interventional studies under Inflammation, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's planned 24 months is below that.
Counting every sponsor, half of 149 studies reached it within 29 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Parecoxib
St. Anne's University Hospital Brno, Czech Republic