Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage
NCT ID: NCT03741530
Last Updated: 2022-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2018-12-15
2020-09-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Glibenclamide group
Giving standard management for ICH plus glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.
Glibenclamide Tablets
Giving glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.
Standard management for ICH
Usual care and drug in hospital
Control group
Giving standard management for ICH
Standard management for ICH
Usual care and drug in hospital
Interventions
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Glibenclamide Tablets
Giving glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.
Standard management for ICH
Usual care and drug in hospital
Eligibility Criteria
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Inclusion Criteria
2. A baseline CT with basal ganglia hemorrhage of 5 to 30 mL
3. Glasgow Coma Scale (GCS) score ≥ 6
4. Symptom onset less than 72 hours prior to admission
5. Informed consent
Exclusion Criteria
2. Hemorrhage breaking into ventricles of brain
3. Prior significant disability (mRS ≥ 3)
4. Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR \<30ml/min/1.73m2
5. Severe liver disorder, or ALT \>3 times or bilirubin \>2 times upper limit of normal
6. Blood glucose \< 55 mg/dL (3.1 mmol/L）at enrollment, or with the history of hypoglycemia
7. With acute ST elevation infarction, or decompensated heart failure, or cardiac arrest, or acute coronary syndrome, or known history of admission for acute coronary syndrome, or acute myocardial infarction, or coronary intervention in the past 3 months
8. Treatment with sulfonylurea in the past 7 days, including glyburide, glyburide plus metformin, glimepiride, repaglinide, glipizide, gliclazide, tolbutamide and glibornuride
9. Treatment with bosentan in the past 7 days
10. Be allergic to sulfa or other sulfonylurea drugs
11. Known G6PD deficiency
12. Pregnant women
13. Breast-feeding women disagreeing to participate the study or stop breastfeeding during and after the study
14. Be enrolled in other non-observation-only study with receiving an investigational drug
15. Life expectancy \<3 months due to other diseases rather than current ICH
16. Refusing to be enrolled, or having poor compliance, or tending to withdraw
18 Years
70 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Principal Investigators
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Wen Jiang, PhD
Role: STUDY_DIRECTOR
Department of Neurology, Xijing Hospital, Fourth Military Medical
Locations
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Ankang Central Hospital
Ankang, Shaanxi, China
Hanzhong Central Hospital
Hanzhong, Shaanxi, China
Xijing Hospital
Xi'an, Shaanxi, China
Tangdu Hospital
Xi'an, Shaanxi, China
Xianyang Central Hospital
Xianyang, Shaanxi, China
Countries
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References
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Keep RF, Hua Y, Xi G. Intracerebral haemorrhage: mechanisms of injury and therapeutic targets. Lancet Neurol. 2012 Aug;11(8):720-31. doi: 10.1016/S1474-4422(12)70104-7. Epub 2012 Jun 13.
Gebel JM Jr, Jauch EC, Brott TG, Khoury J, Sauerbeck L, Salisbury S, Spilker J, Tomsick TA, Duldner J, Broderick JP. Natural history of perihematomal edema in patients with hyperacute spontaneous intracerebral hemorrhage. Stroke. 2002 Nov;33(11):2631-5. doi: 10.1161/01.str.0000035284.12699.84.
Inaji M, Tomita H, Tone O, Tamaki M, Suzuki R, Ohno K. Chronological changes of perihematomal edema of human intracerebral hematoma. Acta Neurochir Suppl. 2003;86:445-8. doi: 10.1007/978-3-7091-0651-8_91.
Butcher KS, Baird T, MacGregor L, Desmond P, Tress B, Davis S. Perihematomal edema in primary intracerebral hemorrhage is plasma derived. Stroke. 2004 Aug;35(8):1879-85. doi: 10.1161/01.STR.0000131807.54742.1a. Epub 2004 Jun 3.
Xi G, Keep RF, Hoff JT. Mechanisms of brain injury after intracerebral haemorrhage. Lancet Neurol. 2006 Jan;5(1):53-63. doi: 10.1016/S1474-4422(05)70283-0.
Shi Y, Leak RK, Keep RF, Chen J. Translational Stroke Research on Blood-Brain Barrier Damage: Challenges, Perspectives, and Goals. Transl Stroke Res. 2016 Apr;7(2):89-92. doi: 10.1007/s12975-016-0447-9. Epub 2016 Jan 13. No abstract available.
Jiang B, Li L, Chen Q, Tao Y, Yang L, Zhang B, Zhang JH, Feng H, Chen Z, Tang J, Zhu G. Role of Glibenclamide in Brain Injury After Intracerebral Hemorrhage. Transl Stroke Res. 2017 Apr;8(2):183-193. doi: 10.1007/s12975-016-0506-2. Epub 2016 Nov 3.
Zhao J, Song C, Li D, Yang X, Yu L, Wang K, Wu J, Wang X, Li D, Zhang B, Li B, Guo J, Feng W, Fu F, Gu X, Qian J, Li J, Yuan X, Liu Q, Chen J, Wang X, Liu Y, Wei D, Wang L, Shang L, Yang F, Jiang W; GATE-ICH Study Group. Efficacy and safety of glibenclamide therapy after intracerebral haemorrhage (GATE-ICH): A multicentre, prospective, randomised, controlled, open-label, blinded-endpoint, phase 2 clinical trial. EClinicalMedicine. 2022 Sep 23;53:101666. doi: 10.1016/j.eclinm.2022.101666. eCollection 2022 Nov.
Zhao J, Yang F, Song C, Li L, Yang X, Wang X, Yu L, Guo J, Wang K, Fu F, Jiang W. Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): Study Protocol for a Multicenter Randomized, Controlled, Assessor-Blinded Trial. Front Neurol. 2021 Apr 27;12:656520. doi: 10.3389/fneur.2021.656520. eCollection 2021.
Other Identifiers
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KY20182067-X-3
Identifier Type: -
Identifier Source: org_study_id
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