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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00526214

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage	Drug: celecoxib medication	N/A

Detailed Description

INCLUSION/EXCLUSION CRITERIA
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

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).

OTHER THERAPY

-No limitation of other medications except NSAIDs, anticoagulation and antiplatelet agent because of aggravating the symptoms

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

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multi-center, Prospective Randomized, Comparative Open With Blinded Endpoints (PROBE) Trial to Assess the Safety and Effectiveness of Administration of Celecoxib in Patients With Intracerebral Hemorrhage

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 In the control group, patients will not take the drug. We do not use placebo drugs.
Experimental: 2 In the intervention group, patients will take celecoxib.	Drug: celecoxib medication In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days. Other Names: celecoxib(celebrex)

Arm

Intervention/Treatment

No Intervention: 1

In the control group, patients will not take the drug. We do not use placebo drugs.

Experimental: 2

In the intervention group, patients will take celecoxib.

Drug: celecoxib medication

In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.

Other Names:

celecoxib(celebrex)

Outcome Measures

Primary Outcome Measures

Change of volume of perihematomal edema as assessed by brain CT [at 1st day of admission and repeated at 7th±1 day]
Brain CT scanning for measurement of volumes of ICH and perihematomal edema was performed at 1st day of admission and repeated at 7th±1 day. Considering some possible errors in measurement of edema volume, at follow-up CT scan, the decrease more than 20% from the initial edema volume was coded as "decreased" edema volume; the increase more than 20% was coded as "increased"; the change between -20% and 20% was coded as "unchanged".

Secondary Outcome Measures

The neurological status at 90 day using E-GOS and mRS [90 days after onset.]
The secondary endpoints were neurological status at 90 day using E-GOS and mRS. Good outcome was defined as 6 or more in E-GOS score, and 2 or less in mRS score.
Change of ICH volume between the initial and the follow-up CT scans [Day1, Day 7]
Change of ICH volume between the initial and the follow-up CT scans. In this analysis, the 20% criterion was applied as mentioned in the edema analysis
Major and minor adverse events [anytime for 3 months]
the cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Exclusion Criteria:

Planned surgical evacuation of hematoma within 24hrs
Secondary ICH due to trauma or aneurismal rupture or etc
Taking antithrombotics or other NSAIDs previously
Pregnancy
Other physical condition, making the patient difficult to participate the study (decided by the neurologist or the physician).