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

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

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

Study Overview

• Status: Completed
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Drug: celecoxib medication

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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms
2. Supratentorial location of hemorrhage
3. Older than 17 yrs

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of volume of perihematomal edema as assessed by brain CT	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".	at 1st day of admission and repeated at 7th±1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The neurological status at 90 day using E-GOS and mRS	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.	90 days after onset.
Change of ICH volume between the initial and the follow-up CT scans	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	Day1, Day 7
Major and minor adverse events	the cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study	anytime for 3 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jae-Kyu Roh, MD, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• Chu K, Jeong SW, Jung KH, Han SY, Lee ST, Kim M, Roh JK. Celecoxib induces functional recovery after intracerebral hemorrhage with reduction of brain edema and perihematomal cell death. J Cereb Blood Flow Metab. 2004 Aug;24(8):926-33. doi: 10.1097/01.WCB.0000130866.25040.7D.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: September 6, 2007
• First Submitted That Met QC Criteria: September 6, 2007
• First Posted (Estimate): September 10, 2007

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Spontaneous intracerebral hemorrhage; Acute Spontaneous, Supratentorial intracerebral hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: H-0704-028-205; 12-2007-0084