Intracerebral HemorrhageGATE-ICHNCT03741530
Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage
A study testing Glibenclamide Tablets and Standard management for ICH in people with Intracerebral Hemorrhage, run by Xijing Hospital at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Glibenclamide Tablets and Standard management for ICH
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 5 sitesChina
- Study dates
- 15 Dec 2018to 23 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years with a primary ICH
- A baseline CT with basal ganglia hemorrhage of 5 to 30 mL
- Glasgow Coma Scale (GCS) score ≥ 6
- Symptom onset less than 72 hours prior to admission
- Informed consent
Who cannot join
- Supratentorial ICH planned to evacuation of a large hematoma
- Hemorrhage breaking into ventricles of brain
- Prior significant disability (mRS ≥ 3)
- Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR <30ml/min/1.73m2
- Severe liver disorder, or ALT >3 times or bilirubin >2 times upper limit of normal
- Blood glucose < 55 mg/dL (3.1 mmol/L）at enrollment, or with the history of hypoglycemia
Show all 16Show fewer
- 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
- Treatment with sulfonylurea in the past 7 days, including glyburide, glyburide plus metformin, glimepiride, repaglinide, glipizide, gliclazide, tolbutamide and glibornuride
- Treatment with bosentan in the past 7 days
- Be allergic to sulfa or other sulfonylurea drugs
- Known G6PD deficiency
- Pregnant women
- Breast-feeding women disagreeing to participate the study or stop breastfeeding during and after the study
- Be enrolled in other non-observation-only study with receiving an investigational drug
- Life expectancy <3 months due to other diseases rather than current ICH
- Refusing to be enrolled, or having poor compliance, or tending to withdraw
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Ankang Central Hospital
Ankang, Shaanxi, 725000
Hanzhong Central Hospital
Hanzhong, Shaanxi, 723000
Xijing Hospital
Xi'an, Shaanxi, 710032
Tangdu Hospital
Xi'an, Shaanxi, 710038
Xianyang Central Hospital
Xianyang, Shaanxi, 712000
About this study
Official title: Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): a Multi-center Randomized, Controlled, Assessor-blinded Trial
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.
Read the 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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Glibenclamide Tablets, Standard management for ICH
- Keywords
- Intracerebral hemorrhage, Perihematomal edema, Disability, Clinical trial
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glibenclamide TabletsDrug
Giving glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.
Standard management for ICHOther
Usual care and drug in hospital
| Study group | Role | What they receive |
|---|---|---|
| Glibenclamide group | Experimental | 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. Receives: Drug: Glibenclamide Tablets; Other: Standard management for ICH |
| Control group | Placebo comparator | Giving standard management for ICH Receives: Other: Standard management for ICH |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of death or major disability
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).
Measured: 90 days after the onset
Secondary outcomes (13)
The change in the volume of ICH from the initial to follow-up CT scans
Measured: 3 days after onset
The change in the volume of PHE from the initial to follow-up CT scans
Measured: 3 days after onset
The change in the volume of ICH from the initial to follow-up CT scans
Measured: 7 days after onset
The change in the volume of PHE from the initial to follow-up CT scans
Measured: 7 days after onset
The proportion of death or major disability
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).
Measured: 3 days after onset
National Institute of Health stroke scale
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.
Measured: 3 days after onset
Glasgow Coma Scale
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).
Measured: 3 days after onset
Barthel Index
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.
Measured: 3 days after onset
The proportion of death or major disability
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).
Measured: 7 days after onset
National Institute of Health stroke scale
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.
Measured: 7 days after onset
Glasgow Coma Scale
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).
Measured: 7 days after onset
Barthel Index
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.
Measured: 7 days after onset
Barthel Index
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.
Measured: 90 days after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start15 Dec 2018
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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 Xijing 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Jiang, PhD, Study director, Department of Neurology, Xijing Hospital, Fourth Military Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741530
- Sponsor's protocol ID
- KY20182067-X-3
- Acronym
- GATE-ICH
- Status last verified
- Sep 2020
- First submitted
- 8 Nov 2018
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22698888Gebel 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.
PubMed 12411653Inaji 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.
PubMed 14753483Butcher 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.
PubMed 15178826Xi 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.
PubMed 16361023Shi 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.
PubMed 26757714Jiang 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.
PubMed 27807801Zhao 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.
PubMed 36177443Zhao 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.
PubMed 33986719
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): a Multi-center Randomized, Controlled, Assessor-blinded Trial
- ClinicalTrials.gov ID
- NCT03741530
- Acronym / sponsor ID
- GATE-ICH / KY20182067-X-3
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral hemorrhage, Perihematomal edema, Disability, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 15 Nov 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glibenclamide group | Experimental | Drug: Glibenclamide Tablets, Other: Standard management for ICHGiving standard management for ICH plus glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment. |
| Control group | Placebo comparator | Other: Standard management for ICHGiving standard management for ICH |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 years with a primary ICH
- A baseline CT with basal ganglia hemorrhage of 5 to 30 mL
- Glasgow Coma Scale (GCS) score ≥ 6
- Symptom onset less than 72 hours prior to admission
- Informed consent
Key exclusion criteria (16 listed)
- Supratentorial ICH planned to evacuation of a large hematoma
- Hemorrhage breaking into ventricles of brain
- Prior significant disability (mRS ≥ 3)
- Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR <30ml/min/1.73m2
- Severe liver disorder, or ALT >3 times or bilirubin >2 times upper limit of normal
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 |
|---|---|---|
| Glibenclamide TabletsGiving glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment. | Drug | Glibenclamide group |
| Standard management for ICHUsual care and drug in hospital | Other | Control group, Glibenclamide group |
Primary outcome
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).
13 secondary outcomes
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
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
The proportion of death or major disability
Time frame: 7 days after onset
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Background: PubMed 22698888Keep 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.
- Background: PubMed 12411653Gebel 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.
- Background: PubMed 14753483Inaji 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.
- Background: PubMed 15178826Butcher 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.
- Background: PubMed 16361023Xi 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.
- Background: PubMed 26757714Shi 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.
- Background: PubMed 27807801Jiang 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.
- Derived from this study: PubMed 36177443Zhao 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.
- Derived from this study: PubMed 33986719Zhao 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.
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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. This study is not recruiting at the moment.
Wen Jiang, PhD study director
Department of Neurology, Xijing Hospital, Fourth Military Medical
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glibenclamide Tablets and Standard management for ICH in people with Intracerebral Hemorrhage, run by Xijing Hospital at 5 sites in China.
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 5 inclusion and 16 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: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of death or major disability (time frame: 90 days after the onset). 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 NCT03741530, which also lists 9 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 8 Apr 2022.