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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 : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: Glibenclamide Tablets Other: Standard management for ICH Not Applicable

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 200 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): a Multi-center Randomized, Controlled, Open-label Trial
Actual Study Start Date : November 25, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Edema

Arm Intervention/treatment
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.
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

Placebo Comparator: Control group
Giving standard management for ICH
Other: Standard management for ICH
Usual care and drug in hospital




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. The change in the midline shift from the initial to follow-up CT scans [ Time Frame: 3 days after onset ]
  2. The change in the volume of ICH from the initial to follow-up CT scans [ Time Frame: 3 days after onset ]
  3. The change in the volume of PHE from the initial to follow-up CT scans [ Time Frame: 3 days after onset ]
  4. The change in the midline shift from the initial to follow-up CT scans [ Time Frame: 7 days after onset ]
  5. The change in the volume of ICH from the initial to follow-up CT scans [ Time Frame: 7 days after onset ]
  6. The change in the volume of PHE from the initial to follow-up CT scans [ Time Frame: 7 days after onset ]
  7. 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).

  8. 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.

  9. 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).

  10. 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.

  11. 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).

  12. 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.

  13. 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).

  14. 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.

  15. 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.


Other Outcome Measures:
  1. Incidence of hypoglycemia [ Time Frame: 7 days after onset ]
    Blood glucose <3.1 mmol/L

  2. Incidence of symptomatic hypoglycemia [ Time Frame: 7 days after onset ]
    Blood glucose <3.1 mmol/L with investigator-identified hypoglycemic symptoms

  3. Incidence of cardiac-related Adverse Events and Serious Adverse Events [ Time Frame: 7 days after onset ]
  4. Incidence of all-cause mortality [ Time Frame: 90 days after onset ]
  5. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 90 days after onset ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741530


Contacts
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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

Locations
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China, Shaanxi
Ankang Central Hospital Recruiting
Ankang, Shaanxi, China, 725000
Contact: Xingsheng Wang         
Hanzhong Central Hospital Recruiting
Hanzhong, Shaanxi, China, 723000
Contact: Zheng Chen         
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Jingjing Zhao    8602984773664    zhaojing0110@126.com   
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Miao Bai         
Xianyang Central Hospital Recruiting
Xianyang, Shaanxi, China, 712000
Contact: Tao Han         
Sponsors and Collaborators
Xijing Hospital
Investigators
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Study Director: Wen Jiang, PhD Department of Neurology, Xijing Hospital, Fourth Military Medical

Publications:
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03741530     History of Changes
Other Study ID Numbers: KY20182067-X-2
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xijing Hospital:
Intracerebral hemorrhage
Perihematomal edema
Disability
Clinical trial

Additional relevant MeSH terms:
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Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Imidacloprid
Glyburide
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hypoglycemic Agents