Effects of Celecoxib on Intracerebral Hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Natinal Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Shin-Joe Yeh, MD PhD
• Email: shinjoeyeh@gmail.com
• Phone: 886-2-23123456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.