Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage

NCT05434065 | Recruiting Phase 2

• 1 other identifier: 202112193MINB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral hemorrhage; Celecoxib; COX-2 inhibitor

Outcome Measures

Primary Outcomes (3)

• Hematoma expansion volume percentage

  (Followed hematoma volume - initial hematoma volume) / initial hematoma volume x100%

  Day 2

• Perihematomal edema change volume percentage

  (Followed perihematomal edema volume - initial perihematomal edema volume) / initial perihematomal edema volume x100%

  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%

  Day 2, 7

Secondary Outcomes (8)

• Hematoma expansion volume

  Day 2

• Percentage of participants with hematoma expansion (33% relative or 12.5 mL absolute volume increase)

  Day 2

• Perihematomal edema increase volume

  Day 2, 7±1

• Hematoma and perihematomal edema expansion volume

  Day 2, 7±1

• Hematoma and perihematomal edema expansion percentage

  Day 2, 7±1

Study Arms (2)

Celebrex treatment arm

EXPERIMENTAL

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

Drug: Celecoxib 200mg

Control arm

NO INTERVENTION

No trial medication will be given.

Interventions

Celecoxib 200mg DRUG

Using celecoxib (200 mg/day) for 21 days starting within 6 hours after onset of ICH

Celebrex treatment arm

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Natinal Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (2)

• 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.

  PMID: 23551657 RESULT

• 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.

  PMID: 21346218 RESULT

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shin-Joe Yeh, MD PhD

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Shin-Joe Yeh, MD PhD

CONTACT

886-2-23123456; shinjoeyeh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intracerebral hemorrhage

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: These data will be available on the publication of this study.

Locations

TW (1)