Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage
Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
This trial is a phase IIa human clinical study, in which 30 patients with intracerebral
hemorrhage (ICH) at basal ganglion or thalamus within 6 h after onset will be enrolled. 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.
Primary outcome measures:
1. Hematoma expansion %
2. Perihematomal volume increase %
3. Percentage of participants with increased perihematomal edema volume (increase > 20%)
Secondary outcome measures:
1. Hematoma expansion volume
2. Percentage of participants with hematoma expansion (33% relative or 12.5 mL absolute
volume increase)
3. Perihematomal edema increase volume
4. Hematoma and perihematomal edema expansion volume
5. Hematoma and perihematomal edema expansion %
6. Improvement in NIHSS (highest NIHSS score - NIHSS on day 21)
7. Percentage of participants with adverse events (AEs): serious AEs (death, recurrent
stroke, myocardial infarction, gastrointestinal bleeding requiring blood transfusion,
etc.), nonserious AEs (abdominal pain, gastrointestinal bleeding without requiring blood
transfusion, other bleeding, skin rash, etc.)
8. 3-month modified Rankin scale (mRS) score