[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560601":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":69,"collaborators":71,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":101,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"St. Anne's University Hospital Brno, Czech Republic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active - Parecoxib","EXPERIMENTAL","Parecoxib 40 mg\u002F100 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\u002F100 ml is administered every 12 hours for 5 days. The maximum daily dose is 80 mg.\n\nIn patients with moderate hepatic impairment (Child-Pugh score 7-9), parecoxib is started at 20 mg\u002F50 mL and continued at this dose every 12 hours. The maximum daily dose is 40 mg.\n\nParticipants 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.",[13],"Drug: Parecoxib",{"label":15,"type":16,"description":17,"interventionNames":18},"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.\n\nThe 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.\n\nParticipants 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.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Parecoxib","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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo intravenous injection can be administered quickly and directly into a vein or through an intravenous infusion set.",[15],[32],{"name":33,"affiliation":5,"role":34},"Peter Solar","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Lucie Tesárková","CONTACT","+420 543 185 174","lucie.tesarkova@fnusa.cz",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Klara Kostelanska, PhD","+420 543 185 526","klara.kostelanska@fnusa.cz",[46],{"facility":47,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":26,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"St. Anne's University Hospital Brno","Brno","Czech Republic","602 00","Czechia",{"type":53,"coordinates":54},"Point",[55,56],16.60796,49.19522,{"lat":56,"lon":55},[59,63,64,66],{"name":60,"role":38,"phone":61,"phoneExt":26,"email":62},"Peter Solar, MD","+ 420 543 182 703","peter.solar@fnusa.cz",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},{"name":65,"role":34,"phone":26,"phoneExt":26,"email":26},"Peter Solar, M.D., Ph.D.",{"name":67,"role":68,"phone":26,"phoneExt":26,"email":26},"Radim Jancalek, M.D., Ph.D.","SUB_INVESTIGATOR",{"type":70,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[72,74],{"name":73,"class":6},"Masaryk University",{"name":75,"class":76},"CZECRIN - Czech Clinical Research Infrastructure Network","UNKNOWN","100560601","phase-2-evaluation-of-the-safety-and-efficacy-of-parecoxib-in-patients-with-subarachnoid-hemorrhage-100560601",false,"NCT06579274","Evaluation of the Safety and Efficacy of Parecoxib in Patients With Subarachnoid Hemorrhage","A Randomized, Placebo-controlled, Double-blind Clinical Trial Evaluating the Safety and Efficacy of Parecoxib in Hospitalized Patients With Spontaneous Subarachnoid Hemorrhage","PARISAH","Inclusion Criteria:\n\n* Signed informed consent\n* Age: 18-85 years\n* Weight\\> 50 kg\n* Spontaneous SAH diagnosed on a native CT brain max. 48 hours after the first symptoms\n* 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\n* 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.\n\nExclusion Criteria:\n\n* Symptoms of SAH without the finding of blood on the initial native CT scan of the brain\n* SAH from a cause other than a ruptured aneurysm, e.g. A-V malformation, traumatic SAH\n* Pregnancy and breastfeeding (pregnancy test)\n* Known hypersensitivity to the components of the product\n* Allergic reaction to the active substance or sulfonamides in the anamnesis\n* 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)\n* Severe hepatic insufficiency (serum albumin level \\\u003C25 g\u002Fl or Child-Pugh score less than 10).\n* Active peptic ulcer or bleeding from the gastrointestinal tract in the anamnesis\n* Inflammatory bowel disease in the anamnesis\n* Congestive heart failure (NYHA II-IV) in history.\n* Proven ischemic heart disease, peripheral arterial insufficiency.\n* Participation in another clinical study (a gap of at least five half-lives before administration of the medicinal product under investigation).","ALL","18 Years","85 Years",{"count":89,"type":90},112,"ESTIMATED","INTERVENTIONAL",[93],"PHASE2","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.",[96],"Neurological Complication",[98,99,100],"subarachnoidal hemorrhage","inflammation","NSAIDs","NOT_YET_RECRUITING","2024-08-26",{"date":104,"type":105},"2024-08-30","ACTUAL",{"date":107,"type":90},"2025-01-01",{"date":109,"type":90},"2027-07-01",{"name":5,"class":6},1]