RecruitingPhase 2NCT05434065

Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage

Sponsor

National Taiwan University Hospital

Enrollment

60 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Intracerebral Hemorrhage

Summary

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.

Eligibility

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria8

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 Criteria13

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