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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00526214
First received: September 6, 2007
Last updated: March 26, 2010
Last verified: March 2010
  Purpose

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 Intervention
Intracerebral Hemorrhage
Drug: celecoxib medication

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Change of volume of perihematomal edema as assessed by brain CT [ Time Frame: at 1st day of admission and repeated at 7th±1 day ] [ Designated as safety issue: No ]
    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 [ Time Frame: 90 days after onset. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day1, Day 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: anytime for 3 months ] [ Designated as safety issue: Yes ]
    the cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study


Estimated Enrollment: 40
Study Start Date: October 2007
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
In the control group, patients will not take the drug. We do not use placebo drugs.
Drug: celecoxib medication
In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.
Other Name: celecoxib(celebrex)

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526214

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jae-Kyu Roh, MD, PhD Seoul National University Hospital
  More Information

Publications:
Responsible Party: Jae-Kyu Roh/MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00526214     History of Changes
Other Study ID Numbers: H-0704-028-205, 12-2007-0084
Study First Received: September 6, 2007
Last Updated: March 26, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Spontaneous intracerebral hemorrhage
Acute Spontaneous, Supratentorial intracerebral hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 24, 2014