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Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage

RecruitingPhase 2Ages 20 Years - 80 YearsAllNational Taiwan University Hospital
NCT05434065 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This trial is a phase IIa human clinical study, in which 60 patients with intracerebral hemorrhage (ICH) at basal ganglion or thalamus within 6 h after onset will be enrolled. Patients will be randomly assigned as treatment group or control group as 1:1 distribution. Early initiation of celecoxib within 6 h after ICH and treatment for 21 days will be performed. The safety will be evaluated by drug adverse effects. The efficacy will be assessed by hematoma expansion, brain edema, and 3-month modified Rankin scale.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Acute ICH patients able to take the first dose within 6 hours after onset * ICH location at basal ganglion or thalamus * ICH volume \< 30 mL * Normal renal function (creatinine \[Cr\] ≤ 1.3 mg/dL) * No surgical indication * Signed informed consent * Consciousness clear or mild drowsiness * Age 20-80 years old Exclusion Criteria: * Allergy to celecoxib or other non-steroid anti-inflammatory drugs (NSAIDs) * Post-coronary artery bypass graft (CABG) within 14 days * Previous myocardial infarction * Previous peptic ulcer disease * Abnormal renal function (Cr \> 1.3 mg/dL) * Surgery for this ICH * Pregnancy or under breast feeding (If the female case is not sure about pregnancy, pregnancy test will be performed) * Premorbid mRS \> or = 3 * Previous ICH not at basal ganglia or thalamus * Coagulation abnormality (abnormal PT/PTT), or taking anticoagulant or antiplatelet * Abnormal liver function (ALT \> 3x upper limit) * History of severe bleeding event, requiring admission or blood transfusion * History of stenting or valve replacement, requiring long-term using antithrombotics
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What it tests

  • Celecoxib 200mg
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Where

1 site
Natinal Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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