Effects of Celecoxib on Intracerebral Hemorrhage
Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage
This study is testing if the medication celecoxib can help improve recovery for people who have had bleeding in the brain from an intracerebral hemorrhage.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05434065 on ClinicalTrials.gov |
What this trial studies
This phase IIa clinical trial investigates the safety and efficacy of celecoxib, a COX-2 inhibitor, in patients with intracerebral hemorrhage (ICH) occurring in the basal ganglion or thalamus. A total of 60 patients will be enrolled and randomly assigned to receive either celecoxib or a control treatment within 6 hours of ICH onset, with treatment lasting for 21 days. The study will evaluate outcomes such as hematoma expansion, brain edema, and neurological function using various scales and imaging techniques. Safety will be monitored through adverse effects and renal function assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-80 with acute ICH in the basal ganglion or thalamus, who can start treatment within 6 hours of onset.
Not a fit: Patients with a history of severe bleeding events, significant renal or liver dysfunction, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes for patients suffering from intracerebral hemorrhage.
How similar studies have performed: Previous studies have shown potential benefits of COX-2 inhibitors in similar conditions, but this specific approach is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taipei
- Natinal Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Shin-Joe Yeh, MD PhD
- Email: shinjoeyeh@gmail.com
- Phone: 886-2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.