Status:
RECRUITING
Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief 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 randoml...
Detailed Description
A phase IIa human clinical trial will be performed to clarify the safety and efficacy of using usual dose of celecoxib (200 mg/day) for 21 days starting within 6 hours after onset of ICH. Totally 60 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05434065
Start Date
January 1 2023
End Date
December 31 2027
Last Update
September 20 2024
Active Locations (1)
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1
Natinal Taiwan University Hospital
Taipei, Taiwan, 100