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Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage

Primary Purpose

Intracerebral Hemorrhage

Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Celecoxib 200mg
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Intracerebral hemorrhage, Celecoxib, COX-2 inhibitor

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute ICH patients able to take the first dose within 6 hours after onset
  • ICH location at basal ganglion or thalamus
  • ICH volume < 30 mL
  • Normal renal function (creatinine [Cr] ≤ 1.3 mg/dL)
  • No surgical indication
  • Signed informed consent
  • Age 20-80 years old

Exclusion Criteria:

  • Allergy to celecoxib or other non-steroid anti-inflammatory drugs (NSAIDs)
  • Post-coronary artery bypass graft (CABG) within 14 days
  • Previous myocardial infarction
  • Previous peptic ulcer disease
  • Abnormal renal function (Cr > 1.3 mg/dL)
  • Surgery for this ICH
  • Pregnancy or under breast feeding (If the female case is not sure about pregnancy, pregnancy test will be performed)

Sites / Locations

  • Natinal Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Celebrex treatment arm

Control arm

Arm Description

Celecoxib 200 mg/dose, started within 6 h after onset, then one dose per day for 21 days.

No trial medication will be given.

Outcomes

Primary Outcome Measures

Hematoma expansion volume percentage
(Followed hematoma volume - initial hematoma volume) / initial hematoma volume x100%
Perihematomal edema change volume percentage
(Followed perihematomal edema volume - initial perihematomal edema volume) / initial perihematomal edema volume x100%
Percentage of participants with perihematomal edema volume change > 20%
Participants with [(followed perihematomal edema volume - initial perihematomal edema volume) / initial perihematomal edema volume x100%] larger than 20% / total participants x100%

Secondary Outcome Measures

Hematoma expansion volume
Followed hematoma volume - initial hematoma volume
Percentage of participants with hematoma expansion (33% relative or 12.5 mL absolute volume increase)
Participants with hematoma expansion on followed CT (33% relative volume increase or 12.5 mL absolute volume increase) / total participants X100%
Perihematomal edema increase volume
Followed perihematomal edema volume - initial perihematomal edema volume
Hematoma and perihematomal edema expansion volume
Total volume of hematoma and perihematomal edema on followed CT - initial total volume of hematoma and perihematomal edema
Hematoma and perihematomal edema expansion percentage
(Total volume of hematoma and perihematomal edema on followed CT - total volume of hematoma and perihematomal edema on initial CT) / total volume of hematoma and perihematomal edema on initial CT X100%
Change in National Institutes of Health Stroke Scale (NIHSS)
NIHSS score on day 21 - initial NIHSS score. NIHSS score ranges from 0 to 42, with higher scores indicating more severe neurological deficit.
Percentage of participants with adverse events (AEs)
serious AEs (death, recurrent stroke, myocardial infarction, gastrointestinal bleeding requiring blood transfusion, etc.), nonserious AEs (abdominal pain, gastrointestinal bleeding without requiring blood transfusion, other bleeding, skin rash, etc.) Percentage of participants with serious AEs = participants with serious AEs / total participants x100% Percentage of participants with nonserious AEs = participants with nonserious AEs / total participants x100% Percentage of participants with AEs = participants with AEs / total participants x100%
modified Rankin scale (mRS) score
Modified Rankin scale (mRS) score is a functional outcome score, ranging from 0 to 6, with higher scores indicating worse outcome.

Full Information

First Posted
June 21, 2022
Last Updated
July 16, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05434065
Brief Title
Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage
Official Title
Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
A phase IIa human clinical trial will be performed to clarify the safety and efficacy of using usual dose of celecoxib (200 mg/day) for 21 days starting within 6 hours after onset of ICH. Totally 60 patients will be enrolled prospectively, and the case number was estimated by statistical methods for the percentage of participants with increased perihematomal edema volume shown in the previous clinical trial (Lee et al., 2013) (estimated by G-power software, settings as: exact test, one sample test, α = 0.05, power = 0.95). Patients will be randomly assigned as treatment group or control group as 1:1 distribution. Intervention: Celecoxib 200 mg per dose, started within 6 h after onset, then one dose per day for 21 days in the treatment group. The low dose of Celecoxib will be used to minimize the side effect of Celecoxib. No trial medication will be given for the control group. Pregnancy will be excluded at enrollment and prevented throughout the treatment period in female cases at reproductive ages. Evaluations: Brain CT: Initial brain CT: for initial hematoma volume (length * width * height /2) Brain CT on day 2 for final hematoma volume and hematoma expansion Brain CT on day 7±1 for perihematomal edema and hematoma resolution Neurological functions: NIHSS score, GCS score, modified Rankin scale (mRS) on day 1, 2, 7±2, 14±2, 21±2, and mRS at 3 months Renal function (creatinine) on day 1, then once per week during day 2-7, day 8-14 and 15-21 Gastrointestinal bleeding evens within 21 days Myocardial infarction evens within 21 days Blood sampling on day 1, 7±2, and 21±2 Patient enrollment: If the patient's consciousness is not clear before the enrollment of this study, his (her) family can decide the enrollment for this patient. Once the patient regains his (her) consciousness, we will reconfirm with the patient about the enrollment of this study. Data checks: The data recorded of this study will be double-checked for their accuracy and compared with predefined ranges to avoid typing error. Plan for missing data: Missing data include those data which are reported as missing, unavailable, uninterpretable, or considered missing because of data inconsistency or out-of-range results. This study will try to minimize missing data by limiting the collection of data to essential information and minimizing the number of follow-up visits, develop a documentation of this study for the methods to screen the participants and the procedures to follow up, appropriate training for all personnel related to this study, and data will be reviewed as close to real-time as possible. Statistical analysis plan: The continuous variables between Celecoxib group and control group will be compared using Mann-Whitney U test if these data are not with normal distribution, or t-test if these data are with normal distribution. Categorical data will be compared using Fisher's exact test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Intracerebral hemorrhage, Celecoxib, COX-2 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Intracerebral hemorrhage
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Celebrex treatment arm
Arm Type
Experimental
Arm Description
Celecoxib 200 mg/dose, started within 6 h after onset, then one dose per day for 21 days.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
No trial medication will be given.
Intervention Type
Drug
Intervention Name(s)
Celecoxib 200mg
Intervention Description
Using celecoxib (200 mg/day) for 21 days starting within 6 hours after onset of ICH
Primary Outcome Measure Information:
Title
Hematoma expansion volume percentage
Description
(Followed hematoma volume - initial hematoma volume) / initial hematoma volume x100%
Time Frame
Day 2
Title
Perihematomal edema change volume percentage
Description
(Followed perihematomal edema volume - initial perihematomal edema volume) / initial perihematomal edema volume x100%
Time Frame
Day 2, 7
Title
Percentage of participants with perihematomal edema volume change > 20%
Description
Participants with [(followed perihematomal edema volume - initial perihematomal edema volume) / initial perihematomal edema volume x100%] larger than 20% / total participants x100%
Time Frame
Day 2, 7
Secondary Outcome Measure Information:
Title
Hematoma expansion volume
Description
Followed hematoma volume - initial hematoma volume
Time Frame
Day 2
Title
Percentage of participants with hematoma expansion (33% relative or 12.5 mL absolute volume increase)
Description
Participants with hematoma expansion on followed CT (33% relative volume increase or 12.5 mL absolute volume increase) / total participants X100%
Time Frame
Day 2
Title
Perihematomal edema increase volume
Description
Followed perihematomal edema volume - initial perihematomal edema volume
Time Frame
Day 2, 7±1
Title
Hematoma and perihematomal edema expansion volume
Description
Total volume of hematoma and perihematomal edema on followed CT - initial total volume of hematoma and perihematomal edema
Time Frame
Day 2, 7±1
Title
Hematoma and perihematomal edema expansion percentage
Description
(Total volume of hematoma and perihematomal edema on followed CT - total volume of hematoma and perihematomal edema on initial CT) / total volume of hematoma and perihematomal edema on initial CT X100%
Time Frame
Day 2, 7±1
Title
Change in National Institutes of Health Stroke Scale (NIHSS)
Description
NIHSS score on day 21 - initial NIHSS score. NIHSS score ranges from 0 to 42, with higher scores indicating more severe neurological deficit.
Time Frame
Day 21±2
Title
Percentage of participants with adverse events (AEs)
Description
serious AEs (death, recurrent stroke, myocardial infarction, gastrointestinal bleeding requiring blood transfusion, etc.), nonserious AEs (abdominal pain, gastrointestinal bleeding without requiring blood transfusion, other bleeding, skin rash, etc.) Percentage of participants with serious AEs = participants with serious AEs / total participants x100% Percentage of participants with nonserious AEs = participants with nonserious AEs / total participants x100% Percentage of participants with AEs = participants with AEs / total participants x100%
Time Frame
Day 1-21
Title
modified Rankin scale (mRS) score
Description
Modified Rankin scale (mRS) score is a functional outcome score, ranging from 0 to 6, with higher scores indicating worse outcome.
Time Frame
3-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute ICH patients able to take the first dose within 6 hours after onset ICH location at basal ganglion or thalamus ICH volume < 30 mL Normal renal function (creatinine [Cr] ≤ 1.3 mg/dL) No surgical indication Signed informed consent Consciousness clear or mild drowsiness Age 20-80 years old Exclusion Criteria: Allergy to celecoxib or other non-steroid anti-inflammatory drugs (NSAIDs) Post-coronary artery bypass graft (CABG) within 14 days Previous myocardial infarction Previous peptic ulcer disease Abnormal renal function (Cr > 1.3 mg/dL) Surgery for this ICH Pregnancy or under breast feeding (If the female case is not sure about pregnancy, pregnancy test will be performed) Premorbid mRS > or = 3 Previous ICH not at basal ganglia or thalamus Coagulation abnormality (abnormal PT/PTT), or taking anticoagulant or antiplatelet Abnormal liver function (ALT > 3x upper limit) History of severe bleeding event, requiring admission or blood transfusion History of stenting or valve replacement, requiring long-term using antithrombotics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shin-Joe Yeh, MD PhD
Phone
886-2-23123456
Ext
62144
Email
shinjoeyeh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shin-Joe Yeh, MD PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Natinal Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shin-Joe Yeh, MD PhD
Phone
+886223123456
Ext
262144
Email
shinjoeyeh@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication will be shared
IPD Sharing Time Frame
Starting 6 months after publication
IPD Sharing Access Criteria
These data will be available on the publication of this study.
Citations:
PubMed Identifier
23551657
Citation
Lee SH, Park HK, Ryu WS, Lee JS, Bae HJ, Han MK, Lee YS, Kwon HM, Kim CK, Park ES, Chung JW, Jung KH, Roh JK. Effects of celecoxib on hematoma and edema volumes in primary intracerebral hemorrhage: a multicenter randomized controlled trial. Eur J Neurol. 2013 Aug;20(8):1161-9. doi: 10.1111/ene.12140. Epub 2013 Mar 29.
Results Reference
result
PubMed Identifier
21346218
Citation
Dowlatshahi D, Demchuk AM, Flaherty ML, Ali M, Lyden PL, Smith EE; VISTA Collaboration. Defining hematoma expansion in intracerebral hemorrhage: relationship with patient outcomes. Neurology. 2011 Apr 5;76(14):1238-44. doi: 10.1212/WNL.0b013e3182143317. Epub 2011 Feb 23.
Results Reference
result

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Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage

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