Subarachnoid HemorrhagePhase 4NCT05137678
Evaluate the Use of Glibenclamide on Acute aSAH
A Phase 4 study testing glibenclamide in people with Subarachnoid Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
A randomized, open-labeled, blank-controlled and prospective trial meant to evaluate the use of glibenclamide on acute aneurysmatic subarachnoid hemorrhage. Patients will allocated randomly in two groups, one for 3.75 mg daily intake of glibenclamide for 7 days and another as a blank contrast. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- glibenclamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2021to 1 Dec 2022
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subarachnoid hemorrhage was diagnosed by digital subtraction angiography, computed tomographic angiogram or magnetic resonance angiography;
- Within 48 hours;
- Age > 18 years old;
- The expected length of stay is more than 7 days;
- Sign informed consent.
Who cannot join
- There was a history of taking sulfonylureas within 30 days before brain injury;
- Combined with neurological or mental diseases, including stroke, epilepsy and dementia;
- Hunt \& Hess grade V patients;
- Severe brain injury (central hernia or hook hernia within 48 hours after admission or after resuscitation) that cannot be solved at present;
- History of alcohol or illicit drug dependence;
- Allergic to sulfonamides or glibenclamide tablets;
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- The international normalized ratio was more than 1.4;
- Renal insufficiency, history of dialysis treatment or serum creatinine more than 2.5 mg / dl;
- Liver cirrhosis or severe liver dysfunction (ALT > 2.5 times the upper normal limit or total bilirubin > 1.5 times the upper normal limit);
- He is taking bosentan tablets to treat pulmonary hypertension;
- There was a history of glucose-6-phosphate dehydrogenase deficiency (faba bean disease);
- The life expectancy is less than one year;
- The gastrointestinal tract should not be used;
- Pregnancy or lactation;
- History of participating in other drug trials within 30 days;
- There were clinical conditions that other researchers did not consider to meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050
qing lin, 13811127173, 13811127173@163.com
About this study
Official title: The Safety and Effectiveness of Glibenclamide in the Treatment of Aneurysm Subarachnoid Hemorrhage（aSAH）: a Randomized Controlled Clinical Study
A randomized, open-labeled, blank-controlled and prospective trial meant to evaluate the use of glibenclamide on acute aneurysmatic subarachnoid hemorrhage. Patients will allocated randomly in two groups, one for 3.75 mg daily intake of glibenclamide for 7 days and another as a blank contrast. General clinical data and late cognitive status will be accessed in both groups.
Read the detailed description
The study is a open-labeled, blank-controlled, prospective and randomized clinical trial, conducted at Tiantan Hospital and Tongren Hospital, affiliated with the Capital Medical University. Patients will be recruited from intensive care units. Appropriate ethics and regulatory approvals will be sought for all subjects, according to the International Conference on Harmonization guidelines for good clinical practice (ICH GCP). Investigators will obtain informed written consent from all patients or their legal representative. Recruitment will take place between 2021 and 2022.
Patients will be randomly assigned (1:1) to receive either glibenclamide 3.75mg or blank contrast. A computer-generated randomization code will be used to randomize patients. Patients will start treatment as soon as possible within 48 h of the stroke, with a daily dose till the 7 days after the recruitment. Trial medication consisted of one and a half pieces of tablet a day, given orally or via a nasogastric tube. Aneurysm treatment, either by microsurgery or embolization, will be performed as soon as possible, according with the standard of care for the recruiting center. Nimodipine 60mg, every six hours, will be started on admission and continued till two weeks later, in all patients as standard of care.
Patient's demographics, medical history and relevant investigation results will be collected. The severity of the hemorrhage will be clinically assessed by World Federation of Neurosurgical Societies grading scale and radiologically using the modified Fischer scale. At 90 days of follow up patients will be interviewed with modified Rankin scale (mRS) questionnaire (a scale that measures degree of incapacity/ dependence and mortality after neurological events) by a physician with no knowledge of treatment allocation. The main hypothesis is that, once compared with standard of care, glibenclamide 3.75mg will provide better clinical outcome and additionally will decrease mortality and improve quality of life and cognitive performance after 90 days.
Sample size: Previous studies have shown that the NSE mean for the third day after subarachnoid hemorrhage is 21 ng/ml, the standard deviation is about 3 ng/ml, and the third day NSE in patients with a good prognosis group is about 19 ng/ml, and the standard deviation is about 3 ng/ml; according to the two-sided test, significance of 5%, two groups of equal number of people, 90% of the degree of certainty, the calculation of the sample size of 98 cases, assuming 10% of the loss of visits, the total sample size is expected to be 110 cases.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- glibenclamide
- Keywords
- Subarachnoid hemorrhage, Brain aneurysms, Glibenclamide
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glibenclamideDrug
Also called Glebenzene
Glibenclamide was given orally or by nasal feeding
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Glibenclamide was given orally or through nasogastric tube, 1.25 mg every 8 hours for 7 days Receives: Drug: glibenclamide |
| Control group | No intervention | No glibenclamide treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Serum neuron-specific enolase（NSE）
change of NSE serum concentrations after treatment
Measured: at 1st, 3rd,7th days after recruitment
Change from Baseline Serum S100 β
change of S100B serum concentrations after treatment
Measured: at 1st, 3rd,7th days after recruitment
Secondary outcomes (5)
The proportion of modified Rankin score (0-2)
The proportion of modified Rankin score (0-2)
Measured: at 90 days
The degree of brain edema
showed by brain CT
Measured: on the 3rd and 7th day after medication
The incidence of delayed cerebral ischemia
The incidence of delayed cerebral ischemia
Measured: up to 3 weeks
The incidence of hypoglycemia
The incidence of hypoglycemia
Measured: up to 7 days
Intracranial pressure
if have
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start19 Oct 2021
- Primary completion19 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the case group were treated with glibenclamide within 10 hours after onset, orally or through nasogastric tube, 1.25 mg each time, once every 8 hours, for 7 consecutive days. The control group was blank control.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Responsible party
- Principal investigator, Guangzhi Shi, Beijing Tiantan Hospital
- Investigators
- guangzhi shi, doctor, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137678
- Sponsor's protocol ID
- glibenclamide study group2
- Status last verified
- Feb 2022
- First submitted
- 19 Oct 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin Q, Zhou D, Ma J, Zhao J, Chen G, Wu L, Li T, Zhao S, Wen H, Yu H, Zhang S, Gao K, Yang R, Shi G. Efficacy and Safety of Early Treatment with Glibenclamide in Patients with Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial. Neurocrit Care. 2024 Dec;41(3):828-839. doi: 10.1007/s12028-024-01999-z. Epub 2024 Aug 8.
PubMed 39117964
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Glibenclamide in the Treatment of Aneurysm Subarachnoid Hemorrhage（aSAH）: a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05137678
- Acronym / sponsor ID
- glibenclamide study group2
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid hemorrhage, Brain aneurysms, Glibenclamide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 19 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 30 Nov 2021 (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.
A randomized, open-labeled, blank-controlled and prospective trial meant to evaluate the use of glibenclamide on acute aneurysmatic subarachnoid hemorrhage. Patients will allocated randomly in two groups, one for 3.75 mg daily intake of glibenclamide for 7 days and another as a blank contrast. General clinical data and late cognitive status will be accessed in both groups.
Detailed description
The study is a open-labeled, blank-controlled, prospective and randomized clinical trial, conducted at Tiantan Hospital and Tongren Hospital, affiliated with the Capital Medical University. Patients will be recruited from intensive care units. Appropriate ethics and regulatory approvals will be sought for all subjects, according to the International Conference on Harmonization guidelines for good clinical practice (ICH GCP). Investigators will obtain informed written consent from all patients or their legal representative. Recruitment will take place between 2021 and 2022.
Patients will be randomly assigned (1:1) to receive either glibenclamide 3.75mg or blank contrast. A computer-generated randomization code will be used to randomize patients. Patients will start treatment as soon as possible within 48 h of the stroke, with a daily dose till the 7 days after the recruitment. Trial medication consisted of one and a half pieces of tablet a day, given orally or via a nasogastric tube. Aneurysm treatment, either by microsurgery or embolization, will be performed as soon as possible, according with the standard of care for the recruiting center. Nimodipine 60mg, every six hours, will be started on admission and continued till two weeks later, in all patients as standard of care.
Patient's demographics, medical history and relevant investigation results will be collected. The severity of the hemorrhage will be clinically assessed by World Federation of Neurosurgical Societies grading scale and radiologically using the modified Fischer scale. At 90 days of follow up patients will be interviewed with modified Rankin scale (mRS) questionnaire (a scale that measures degree of incapacity/ dependence and mortality after neurological events) by a physician with no knowledge of treatment allocation. The main hypothesis is that, once compared with standard of care, glibenclamide 3.75mg will provide better clinical outcome and additionally will decrease mortality and improve quality of life and cognitive performance after 90 days.
Sample size: Previous studies have shown that the NSE mean for the third day after subarachnoid hemorrhage is 21 ng/ml, the standard deviation is about 3 ng/ml, and the third day NSE in patients with a good prognosis group is about 19 ng/ml, and the standard deviation is about 3 ng/ml; according to the two-sided test, significance of 5%, two groups of equal number of people, 90% of the degree of certainty, the calculation of the sample size of 98 cases, assuming 10% of the loss of visits, the total sample size is expected to be 110 cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in the case group were treated with glibenclamide within 10 hours after onset, orally or through nasogastric tube, 1.25 mg each time, once every 8 hours, for 7 consecutive days. The control group was blank control.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: glibenclamideGlibenclamide was given orally or through nasogastric tube, 1.25 mg every 8 hours for 7 days |
| Control group | No intervention | –No glibenclamide treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subarachnoid hemorrhage was diagnosed by digital subtraction angiography, computed tomographic angiogram or magnetic resonance angiography;
- Within 48 hours;
- Age > 18 years old;
- The expected length of stay is more than 7 days;
- Sign informed consent.
Key exclusion criteria (16 listed)
- There was a history of taking sulfonylureas within 30 days before brain injury;
- Combined with neurological or mental diseases, including stroke, epilepsy and dementia;
- Hunt \& Hess grade V patients;
- Severe brain injury (central hernia or hook hernia within 48 hours after admission or after resuscitation) that cannot be solved at present;
- History of alcohol or illicit drug dependence;
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 |
|---|---|---|
| glibenclamideAlso: GlebenzeneGlibenclamide was given orally or by nasal feeding | Drug | Experimental group |
Primary outcome
Change from Baseline Serum neuron-specific enolase（NSE）
Time frame: at 1st, 3rd,7th days after recruitment
change of NSE serum concentrations after treatment
Change from Baseline Serum S100 β
Time frame: at 1st, 3rd,7th days after recruitment
change of S100B serum concentrations after treatment
5 secondary outcomes
The proportion of modified Rankin score (0-2)
Time frame: at 90 days
The degree of brain edema
Time frame: on the 3rd and 7th day after medication
The incidence of delayed cerebral ischemia
Time frame: up to 3 weeks
The incidence of hypoglycemia
Time frame: up to 7 days
Intracranial pressure
Time frame: up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Derived from this study: PubMed 39117964Lin Q, Zhou D, Ma J, Zhao J, Chen G, Wu L, Li T, Zhao S, Wen H, Yu H, Zhang S, Gao K, Yang R, Shi G. Efficacy and Safety of Early Treatment with Glibenclamide in Patients with Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial. Neurocrit Care. 2024 Dec;41(3):828-839. doi: 10.1007/s12028-024-01999-z. Epub 2024 Aug 8.
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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.
guangzhi shi, doctor study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing glibenclamide in people with Subarachnoid Hemorrhage, run by Beijing Tiantan Hospital at 1 site 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: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact qing lin (13811127173, 13811127173@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Serum neuron-specific enolase（NSE） (time frame: at 1st, 3rd,7th days after recruitment). The study lists 2 primary outcomes in all. 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 NCT05137678, which also lists 1 linked publication.
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 14 Feb 2022.