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Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH)

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ClinicalTrials.gov Identifier: NCT03741530
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Tracking Information
First Submitted Date  ICMJE November 8, 2018
First Posted Date  ICMJE November 15, 2018
Last Update Posted Date July 2, 2020
Actual Study Start Date  ICMJE November 25, 2018
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
The proportion of death or major disability [ Time Frame: 90 days after the onset ]
Unfavourable outcome including death and disability is defined as patients achieving modified Rankin Scale (mRS) ≥3. The mRS is used for measuring the degree of disability or dependence in the daily activities of patients with stroke or other neurological diseases. The total score of the scale runs from 0 (perfect health without symptoms) to 6 (death).
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2018)
Death or major disability [ Time Frame: 90 days after the onset ]
The proportion of patients achieving mRS ≥3
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
  • The change in the midline shift from the initial to follow-up CT scans [ Time Frame: 3 days after onset ]
  • The change in the volume of ICH from the initial to follow-up CT scans [ Time Frame: 3 days after onset ]
  • The change in the volume of PHE from the initial to follow-up CT scans [ Time Frame: 3 days after onset ]
  • The change in the volume of ICH from the initial to follow-up CT scans [ Time Frame: 7 days after onset ]
  • The change in the volume of PHE from the initial to follow-up CT scans [ Time Frame: 7 days after onset ]
  • The proportion of death or major disability [ Time Frame: 3 days after onset ]
    Unfavourable outcome including death and disability is defined as patients achieving modified Rankin Scale (mRS) ≥3. The mRS is used for measuring the degree of disability or dependence in the daily activities of patients with stroke or other neurological diseases. The total score of the scale runs from 0 (perfect health without symptoms) to 6 (death).
  • National Institute of Health stroke scale [ Time Frame: 3 days after onset ]
    The National Institutes of Health Stroke Scale (NIHSS) is used by healthcare providers to evaluate the impairment caused by stroke. The total score of the scale runs from 0 to 42. The higher score is an indicative of more severe impairment.
  • Glasgow Coma Scale [ Time Frame: 3 days after onset ]
    The Glasgow Coma Scale is a scale for measuring the conscious state of patients with neurological diseases. The total score of the scale runs from 3 (deep coma or death) to 15 (fully awake person).
  • Barthel Index [ Time Frame: 3 days after onset ]
    The Barthel Index scale is used to measure performance in activities of daily living (ADL). The total score of the scale runs from 0 to 100. The high score of the scale represents favourable performance in activities of daily life.
  • The proportion of death or major disability [ Time Frame: 7 days after onset ]
    Unfavourable outcome including death and disability is defined as patients achieving modified Rankin Scale (mRS) ≥3. The mRS is used for measuring the degree of disability or dependence in the daily activities of patients with stroke or other neurological diseases. The total score of the scale runs from 0 (perfect health without symptoms) to 6 (death).
  • National Institute of Health stroke scale [ Time Frame: 7 days after onset ]
    The National Institutes of Health Stroke Scale (NIHSS) is used by healthcare providers to evaluate the impairment caused by stroke. The total score of the scale runs from 0 to 42. The higher score is an indicative of more severe impairment.
  • Glasgow Coma Scale [ Time Frame: 7 days after onset ]
    The Glasgow Coma Scale is a scale for measuring the conscious state of patients with neurological diseases. The total score of the scale runs from 3 (deep coma or death) to 15 (fully awake person).
  • Barthel Index [ Time Frame: 7 days after onset ]
    The Barthel Index scale is used to measure performance in activities of daily living (ADL). The total score of the scale runs from 0 to 100. The high score of the scale represents favourable performance in activities of daily life.
  • Barthel Index [ Time Frame: 90 days after onset ]
    The Barthel Index scale is used to measure performance in activities of daily living (ADL). The total score of the scale runs from 0 to 100. The high score of the scale represents favourable performance in activities of daily life.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2018)
  • The change in the midline shift from the initial to follow-up CT scans [ Time Frame: 3 days after onset ]
  • The change in the volume of ICH from the initial to follow-up CT scans [ Time Frame: 3 days after onset ]
  • The change in the volume of PHE from the initial to follow-up CT scans [ Time Frame: 3 days after onset ]
  • The change in the midline shift from the initial to follow-up CT scans [ Time Frame: 7 days after onset ]
  • The change in the volume of ICH from the initial to follow-up CT scans [ Time Frame: 7 days after onset ]
  • The change in the volume of PHE from the initial to follow-up CT scans [ Time Frame: 7 days after onset ]
  • Death or major disability modified Rankin scale [ Time Frame: 3 days after onset ]
    The proportion of patients achieving mRS ≥3
  • National Institute of Health stroke scale [ Time Frame: 3 days after onset ]
  • Glasgow Coma Scale [ Time Frame: 3 days after onset ]
  • Barthel Index [ Time Frame: 3 days after onset ]
  • Death or major disability modified Rankin scale [ Time Frame: 7 days after onset ]
    The proportion of patients achieving mRS ≥3
  • National Institute of Health stroke scale [ Time Frame: 7 days after onset ]
  • Glasgow Coma Scale [ Time Frame: 7 days after onset ]
  • Barthel Index [ Time Frame: 7 days after onset ]
  • Barthel Index [ Time Frame: 90 days after onset ]
Current Other Pre-specified Outcome Measures
 (submitted: January 15, 2020)
  • Incidence of hypoglycemia [ Time Frame: 7 days after admission ]
    Blood glucose <3.1 mmol/L
  • Incidence of symptomatic hypoglycemia [ Time Frame: 7 days after admission ]
    Blood glucose <3.1 mmol/L with investigator-identified hypoglycemic symptoms
  • Incidence of cardiac-related Adverse Events and Serious Adverse Events [ Time Frame: 7 days after admission ]
  • Incidence of all-cause mortality [ Time Frame: 90 days after onset ]
  • Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: During hospitalization ]
Original Other Pre-specified Outcome Measures
 (submitted: November 11, 2018)
  • Hypoglycemia [ Time Frame: 7 days after onset ]
  • Symptomatic hypoglycemia (Hypoglycemia with investigator-identified hypoglycemic symptoms) [ Time Frame: 7 days after onset ]
  • Incidence of cardiac-related Adverse Events and Serious Adverse Events [ Time Frame: 7 days after onset ]
  • Incidence of all-cause mortality [ Time Frame: 90 days after onset ]
  • Other Adverse Events and Serious Adverse Events [ Time Frame: 90 days after onset ]
 
Descriptive Information
Brief Title  ICMJE Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage
Official Title  ICMJE Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): a Multi-center Randomized, Controlled, Open-label Trial
Brief Summary The purpose of the present study is to explore the efficacy of small doses of oral glibenclamide on brain edema after acute primary intracerebral hemorrhage (ICH), and improving the prognosis of patients.
Detailed Description In order to explore the efficacy and safety of oral glibenclamide on brain edema after acute primary ICH, a web-based 1:1 randomization process will be employed to assign 220 subjects to Glibenclamide group (giving standard management for ICH plus glibenclamide) or Control group (giving standard management for ICH). The investigators will make a neurofunctional assessment at baseline, and 3 days, 7 days, 90 days after enrollment. The investigators also assess the midline shift, and the change in the volume of ICH and perihematomal edema (PHE) from the initial to follow-up (3 days and 7days after enrollment). The serious adverse events of all-cause mortality, cardiac-related and blood glucose-related adverse events will be collected to assess the safety of glibenclamide.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intracerebral Hemorrhage
Intervention  ICMJE
  • Drug: Glibenclamide Tablets
    Giving glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.
  • Other: Standard management for ICH
    Usual care and drug in hospital
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: Glibenclamide Tablets
    • Other: Standard management for ICH
  • Placebo Comparator: Control group
    Giving standard management for ICH
    Intervention: Other: Standard management for ICH
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2020)
220
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2018)
200
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-70 years with a primary ICH
  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:

  1. Supratentorial ICH planned to evacuation of a large hematoma
  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. Refusing to be enrolled, or having poor compliance, or tending to withdraw
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wen Jiang, PhD 86-029-84771319 ext 8602984771319 jiangwen@fmmu.edu.cn
Contact: Fang Yang, MD 86-029-84771319 ext 8602984771319 fyangx@fmmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03741530
Other Study ID Numbers  ICMJE KY20182067-X-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wen Jiang, PhD Department of Neurology, Xijing Hospital, Fourth Military Medical
PRS Account Xijing Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP