Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Celecoxib

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

• 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)