A Phase 2/3 interventional study of Glibenclamide and Placebo in Acute Stroke, sponsored by Nanfang Hospital, Southern Medical University. Completed at 8 sites in China. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 2/3, Interventional, and Treatment
This study is designed to evaluate the safety and efficacy of oral glibenclamide in acute ischemic stroke patients who under intravenous rt-PA thrombolysis.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 306 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Glibenclamide Tablets
Drug: Glibenclamide
Placebo for Glibenclamide
Drug: Placebo
Glibenclamide is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.
Placebo is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.
Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points
The proportion of mordified Rankin Scale of 0 to 2 points at 90 days
Time frame: 90 days after the stroke onset
Early improvement: The proportion of NIHSS decreased ≥ 4 points
The proportion of NIHSS decreased ≥ 4 points at 7 days
Time frame: 7 days after the stroke onset
Hemorrhagic transformation: The proportion of parenchymal hemorrhagic transformation in cranial CT
The proportion of parenchymal hemorrhagic transformation in cranial CT within 96 hours
Time frame: 96 hours after the stroke onset
Midline shift: The proportion of midline shift ≥ 6 mm in cranial CT
The proportion of midline shift ≥ 6 mm in cranial CT within 96 hours
Time frame: 96 hours after the stroke onset
Functional outcome 2: The modified Rankin Scale distribution
The modified Rankin Scale distribution at 90 days
Time frame: 90 days after the stroke onset
Functional outcome 3: The proportion of Barthel Index of 60-100 points
The proportion of Barthel Index of 60-100 points
Time frame: 90 days after the stroke onset
Functional outcome 4: The proportion of IQCODE of ≤ 3.40
The proportion of Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) of ≤ 3.40 at 6 months and 1 year after the stroke onset
Time frame: 6 months and 1 year after the stroke onset
Blood-brain barrier: The serum concentration of MMP-9
The serum concentration of MMP-9 at baseline, and at 24, 48, and 72 h
Time frame: Baseline, 24, 48, and 72 hours after the stroke onset
Mortality
The mortality at 90 days
Time frame: 90 days after the stroke onset
Early neurological deterioration
The ratio of neurological deterioration (NIHSS increased ≥ 4 points) within 24 hours after the onset
Time frame: 24 hours after the stroke onset
Hypoglycemia
The incidence of hypoglycemia (random blood glucose \< 3.9 mmol/L)
Time frame: 5 days after the stroke onset
Cardiac events
The incidence of cardiac events in cardiac examination (ECG, echocardiography)
Time frame: 30 days after the stroke onset
Pulmonary infection
The incidence of pulmonary infection
Time frame: 7 days within the stroke onset
AEs and SAEs
The incidence of adverse event and serious adverse event
Time frame: 30 days after the stroke onset
Plan to share: No
Ran from Jan 2018 to primary completion in Aug 2022, 55 months.
Of 30 phase 2/3 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 55. This study's 55 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Glyburide
Nanfang Hospital, Southern Medical University →