Administration of Celecoxib for Treatment of Intracerebral Hemorrhage : A Pilot Study "ACE-ICH"

Completed

Phase N/A Results N/A

Trial Description

Primary:
Change of volume of perihematomal edema as assessed by brain CT.
Secondary:
The change of ICH volume between the initial and the follow-up CT scans The neurological status at 90 day using E-GOS and mRS. The cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study

Detailed Description

1. INCLUSION/EXCLUSION CRITERIA
1. Inclusion Criteria
- Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms
- Supratentorial location of hemorrhage
- Older than 17 yrs
- Informed consent before study
2. Exclusion Criteria
- Planned surgical evacuation of hematoma within 24hrs
- Secondary ICH such as trauma or aneurysmal rupture
- Taking anticoagulation previously
- Pregnancy,known allergy to celecoxib, severe liver or kidney disease, or poor performance state were excluded
- Other physical condition, making the patient difficult to participate in this study (decided by the neurologist or the physician).
2. OTHER THERAPY
-No limitation of other medications except NSAIDs, anticoagulation and antiplatelet agent because of aggravating the symptoms
3. STUDY DESIGN Multicenter, prospective randomized, comparative open with blinded endpoints (PROBE) trial to assess the safety and effectiveness of administration of celecoxib for 14 days in patients with intracerebral hemorrhage

Conditions

Interventions

  • CELECOXIB (Celebrex)Drug
    Other Names: Celebrex
    Intervention Desc: Inhibits COX-2 more than COX-1; inhibits growth of oral squamous carcinoma; cardiovascular risk found in long term cancer trial.
  • Celecoxib medication Drug
    Other Names: celecoxib(celebrex)
    Intervention Desc: In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.
    ARM 1: Kind: Experimental
    Label: 1
    Description: In the control group, patients will not take the drug. We do not use placebo drugs.
    ARM 2: Kind: Experimental
    Label: 2
    Description: In the intervention group, patients will take celecoxib.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patient will have baseline CT. NIHSS on days 1,3,7 & 14. mRS on day 1 & day 90. Patients will be randominized to either no intervention or to celecoxib medication. In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days. No limitation of other medications except NSAIDs, anticoagulation and antiplatelet agent because of aggravating the symptoms. Follow-up for 3 months for any significant adverse reaction.

Outcomes

Type Measure Time Frame Safety Issue
Primary Significant adverse events.
Secondary NIHSS; mRS.
Primary Change of volume of perihematomal edema as assessed by brain CT at 1st day of admission and repeated at 7th±1 day No
Secondary The neurological status at 90 day using E-GOS and mRS 90 days after onset. No
Secondary Change of ICH volume between the initial and the follow-up CT scans Day1, Day 7 No
Secondary Major and minor adverse events anytime for 3 months Yes

Sponsors