Actively Recruiting

Phase 2
Age: 20Years - 80Years
All Genders
NCT05434065

Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage

Led by National Taiwan University Hospital · Updated on 2024-09-20

60

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute intracerebral hemorrhage patients able to take first dose within 6 hours after onset
  • Hemorrhage located at basal ganglion or thalamus
  • Hematoma volume less than 30 mL
  • Normal kidney function (creatinine 64 1.3 mg/dL)
  • No indication for surgery
  • Signed informed consent
  • Consciousness clear or mild drowsiness
  • Age between 20 and 80 years old
Not Eligible

You will not qualify if you...

  • Allergy to celecoxib or other non-steroidal anti-inflammatory drugs (NSAIDs)
  • Coronary artery bypass graft surgery within last 14 days
  • Previous myocardial infarction
  • Previous peptic ulcer disease
  • Abnormal kidney function (creatinine > 1.3 mg/dL)
  • Surgery for current intracerebral hemorrhage
  • Pregnancy or breastfeeding
  • Premorbid modified Rankin scale score greater than or equal to 3
  • Previous intracerebral hemorrhage not in basal ganglia or thalamus
  • Blood clotting abnormalities or use of anticoagulant or antiplatelet drugs
  • Abnormal liver function (ALT > 3 times upper limit)
  • History of severe bleeding requiring hospital admission or blood transfusion
  • History of stenting or valve replacement requiring long-term antithrombotic use

AI-Screening

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Trial Site Locations

Total: 1 location

1

Natinal Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

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Research Team

S

Shin-Joe Yeh, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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