Neurological ComplicationPhase 2PARISAHNCT06579274
Evaluation of the Safety and Efficacy of Parecoxib in Patients With Subarachnoid Hemorrhage
A Phase 2 study testing Parecoxib in people with Neurological Complication, run by St. Anne's University Hospital Brno, Czech Republic at 4 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neurological Complication
- What is being tested?
- Parecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 4 sitesCzechia
- Study dates
- 1 Jan 2025to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia4 sites, 4 recruiting
- Recruiting
St. Anne's University Hospital Brno
Brno, Czech Republic, 602 00
Peter Solar, MD, + 420 543 182 703, peter.solar@fnusa.cz
Klara Kostelanska, PhD, +420 543 185 526, klara.kostelanska@fnusa.cz
- Recruiting
University Hospital Olomouc
Olomouc, 779 00
David Krahulík, prof. MD, +420 588 443 451, david.krahulik@fnol.cz
David Krieg, MD
- Recruiting
University Hospital Ostrava
Ostrava, 708 52
Tomáš Hrbáč, associate professor, +420 597 375 470, tomas.hrbac@fno.cz
Jan Krahulik, MD
- Recruiting
Masarykovy nemocnice v Ústí nad Labem, o.z.
Ústí nad Labem, 401 13
Aleš Hejčl, associate professor, +420477112884, ales.hejcl@kzcr.eu
About this study
Official title: A Randomized, Placebo-controlled, Double-blind Clinical Trial Evaluating the Safety and Efficacy of Parecoxib in Hospitalized Patients With Spontaneous Subarachnoid Hemorrhage
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.
Read the 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 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.
- Conditions
- Neurological Complication
- Being tested
- Parecoxib, Placebo
- Keywords
- subarachnoidal hemorrhage, inflammation, NSAIDs
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParecoxibDrug
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.
PlaceboDrug
Placebo intravenous injection can be administered quickly and directly into a vein or through an intravenous infusion set.
| Study group | Role | What they receive |
|---|---|---|
| Active - Parecoxib | Experimental | 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. Receives: Drug: Parecoxib |
| Control - Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 180 days ± 14 days after first dose of parecoxib/placebo
Secondary outcomes (18)
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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Total length of hospitalization
Total length of hospitalization
Measured: 3 months
Occurrence of acute hydrocephalus
Number of patients with acute hydrocephalus
Measured: During the treatment and post treatment period of hospitalization
Occurrence of chronic hydrocephalus
Number of patients with chronic hydrocephalus with V-P shunt implantation
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: Before the 1st dose of parecoxib/placebo, 1., 3. and 5. day of treatment and 10. day of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The clinical trial is planned as a multicenter, prospective, randomized, double-blind, placebo-controlled Phase II clinical trial, a so-called therapeutic exploratory study. This is an investigator-initiated, academic clinical trial to evaluate the safety and efficacy of parecoxib in hospitalized patients with spontaneous SAH.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University, CZECRIN - Czech Clinical Research Infrastructure Network
- Responsible party
- Sponsor
- Investigators
- Peter Solar, Principal investigator, St. Anne's University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579274
- Sponsor's protocol ID
- PAR-FNUSA-2024
- Acronym
- PARISAH
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind Clinical Trial Evaluating the Safety and Efficacy of Parecoxib in Hospitalized Patients With Spontaneous Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT06579274
- Acronym / sponsor ID
- PARISAH / PAR-FNUSA-2024
- Conditions
- Neurological Complication
- Keywords
- subarachnoidal hemorrhage, inflammation, NSAIDs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Collaborators
- Masaryk University, CZECRIN - Czech Clinical Research Infrastructure Network
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The clinical trial is planned as a multicenter, prospective, randomized, double-blind, placebo-controlled Phase II clinical trial, a so-called therapeutic exploratory study. This is an investigator-initiated, academic clinical trial to evaluate the safety and efficacy of parecoxib in hospitalized patients with spontaneous SAH.
| Arm | Type | Receives |
|---|---|---|
| Active - Parecoxib | Experimental | Drug: ParecoxibParecoxib 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. |
| Control - Placebo | Placebo comparator | Drug: PlaceboA 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParecoxibParecoxib (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. | Drug | Active - Parecoxib |
| PlaceboPlacebo intravenous injection can be administered quickly and directly into a vein or through an intravenous infusion set. | Drug | Control - Placebo |
Primary outcome
Influence of parecoxib on outcome of patients with SAH
Time frame: 180 days ± 14 days after first dose of parecoxib/placebo
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).
18 secondary outcomes
Influence of parecoxib on outcome of patients with SAH
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
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)
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
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
Time frame: 3 months
Total length of hospitalization
Time frame: 3 months
Occurrence of acute hydrocephalus
Time frame: During the treatment and post treatment period of hospitalization
Occurrence of chronic hydrocephalus
Time frame: During the treatment and post treatment period of hospitalization, 90 days ± 7 days, 180 days ± 14 days
Occurrence of fevers
Time frame: During the treatment and post treatment period of hospitalization
Occurrence of inflammation
Time frame: During the treatment and post treatment period of hospitalization
Evaluation of pain according to Visual Analogue Scale
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
Time frame: 0, 2, 4, 6, 8 and 10 days after implantation of drainage
Evaluatioon of laboratory markers of inflammatory response in peripheral blood
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.
Time frame: 0, 2, 4, 6, 8 and 10 days after implantation of drainage
Quality of life measured through questionnaires
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
Time frame: After discharge from hospital, six days after administration of the 1st dose of parecoxib/placebo
Serious adverse events
Time frame: During hospitalization, at discharge, 90 days ± 7 days, 180 days ± 14 days after the first dose of parecoxib/placebo
Hepatotoxicity
Time frame: Before the 1st dose of parecoxib/placebo, 1., 3. and 5. day of treatment and 10. day of hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Solar principal investigator
St. Anne's University Hospital Brno, Czech Republic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parecoxib in people with Neurological Complication, run by St. Anne's University Hospital Brno, Czech Republic at 4 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucie Tesárková (+420 543 185 174, lucie.tesarkova@fnusa.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of parecoxib on outcome of patients with SAH (time frame: 180 days ± 14 days after first dose of parecoxib/placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.