Intracerebral HemorrhagePhase 2NCT05434065
Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage
A Phase 2 study testing Celecoxib 200mg in people with Intracerebral Hemorrhage, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Celecoxib 200mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Natinal Taiwan University Hospital
Taipei, 100
Shin-Joe Yeh, MD PhD, +886223123456 ext. 262144, shinjoeyeh@gmail.com
About this study
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.
Read the 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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Celecoxib 200mg
- Keywords
- Intracerebral hemorrhage, Celecoxib, COX-2 inhibitor
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib 200mgDrug
Using celecoxib (200 mg/day) for 21 days starting within 6 hours after onset of ICH
| Study group | Role | What they receive |
|---|---|---|
| Celebrex treatment arm | Experimental | Celecoxib 200 mg/dose, started within 6 h after onset, then one dose per day for 21 days. Receives: Drug: Celecoxib 200mg |
| Control arm | No intervention | No trial medication will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma expansion volume percentage
(Followed hematoma volume - initial hematoma volume) / initial hematoma volume x100%
Measured: Day 2
Perihematomal edema change volume percentage
(Followed perihematomal edema volume - initial perihematomal edema volume) / initial perihematomal edema volume x100%
Measured: Day 2, 7
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%
Measured: Day 2, 7
Secondary outcomes (8)
Hematoma expansion volume
Followed hematoma volume - initial hematoma volume
Measured: Day 2
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%
Measured: Day 2
Perihematomal edema increase volume
Followed perihematomal edema volume - initial perihematomal edema volume
Measured: Day 2, 7±1
Hematoma and perihematomal edema expansion volume
Total volume of hematoma and perihematomal edema on followed CT - initial total volume of hematoma and perihematomal edema
Measured: Day 2, 7±1
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%
Measured: Day 2, 7±1
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.
Measured: Day 21±2
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%
Measured: Day 1-21
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.
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Jan 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intracerebral hemorrhage
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shin-Joe Yeh, MD PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434065
- Sponsor's protocol ID
- 202112193MINB
- Status last verified
- Sep 2024
- First submitted
- 21 Jun 2022
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared
Publications
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.
PubMed 23551657Dowlatshahi 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.
PubMed 21346218
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT05434065
- Acronym / sponsor ID
- 202112193MINB
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral hemorrhage, Celecoxib, COX-2 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intracerebral hemorrhage
| Arm | Type | Receives |
|---|---|---|
| Celebrex treatment arm | Experimental | Drug: Celecoxib 200mgCelecoxib 200 mg/dose, started within 6 h after onset, then one dose per day for 21 days. |
| Control arm | No intervention | –No trial medication will be given. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib 200mgUsing celecoxib (200 mg/day) for 21 days starting within 6 hours after onset of ICH | Drug | Celebrex treatment arm |
Primary outcome
Hematoma expansion volume percentage
Time frame: Day 2
(Followed hematoma volume - initial hematoma volume) / initial hematoma volume x100%
Perihematomal edema change volume percentage
Time frame: Day 2, 7
(Followed perihematomal edema volume - initial perihematomal edema volume) / initial perihematomal edema volume x100%
Percentage of participants with perihematomal edema volume change > 20%
Time frame: Day 2, 7
Participants with [(followed perihematomal edema volume - initial perihematomal edema volume) / initial perihematomal edema volume x100%] larger than 20% / total participants x100%
8 secondary outcomes
Hematoma expansion volume
Time frame: Day 2
Percentage of participants with hematoma expansion (33% relative or 12.5 mL absolute volume increase)
Time frame: Day 2
Perihematomal edema increase volume
Time frame: Day 2, 7±1
Hematoma and perihematomal edema expansion volume
Time frame: Day 2, 7±1
Hematoma and perihematomal edema expansion percentage
Time frame: Day 2, 7±1
Change in National Institutes of Health Stroke Scale (NIHSS)
Time frame: Day 21±2
Percentage of participants with adverse events (AEs)
Time frame: Day 1-21
modified Rankin scale (mRS) score
Time frame: 3-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Results publication: PubMed 23551657Lee 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 publication: PubMed 21346218Dowlatshahi 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shin-Joe Yeh, MD PhD study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib 200mg in people with Intracerebral Hemorrhage, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shin-Joe Yeh, MD PhD (886-2-23123456 ext. 62144, shinjoeyeh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma expansion volume percentage (time frame: Day 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05434065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.