NCT05434065 Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage
| NCT ID | NCT05434065 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Taiwan University Hospital |
| Condition | Intracerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-01-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Shin-Joe Yeh, MD PhD
STUDY CHAIR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT05434065 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05434065 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05434065 currently recruiting?
Yes, NCT05434065 is actively recruiting participants. Contact the research team at shinjoeyeh@gmail.com for enrollment information.
Where is the NCT05434065 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT05434065 clinical trial?
NCT05434065 is sponsored by National Taiwan University Hospital. The principal investigator is Shin-Joe Yeh, MD PhD at National Taiwan University Hospital. The trial plans to enroll 60 participants.