Safety and Efficacy of Glibenclamide Combined With Rt-PA in Acute Cerebral Embolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2023-05-28

Brief Summary

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This study is designed to evaluate the safety and efficacy of oral glibenclamide in acute ischemic stroke patients who under intravenous rt-PA thrombolysis.

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Detailed Description

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Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glibenclamide

Glibenclamide Tablets

Group Type ACTIVE_COMPARATOR

Glibenclamide

Intervention Type DRUG

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

Placebo for Glibenclamide

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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Glibenclamide

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of acute ischemic stroke in the MCA territory (PCA and/or ACA territory involvement in addition to primary MCA territory stroke is acceptable)
* Aged ≥18 and ≤74 years
* A baseline NIHSS score between 4 to 25
* Intravenous rt-PA thrombolysis conducted within 4.5 hours after stroke onset, if known, or the time last seen well \[termed "time last known at neurologic baseline" (TLK@B)\]
* The time to the start of administration of Study Drug must be ≤10 h after time of symptom onset or TLK@B
* Informed consent was signed by the subject or the legal representative

Exclusion Criteria

* Prior to stroke, significant disability exists, with modified Rankin Scale \>1 point
* With medical history or evidence of cerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm or brain tumor
* With clinical or imaging evidence of contralateral cerebral infarction which is believed to have influence on the patient outcome by the investigators
* With clinical or imaging evidence of occlusion in vertebral or basilar artery
* With clinical evidence of brain herniation, e.g., one or two dilated, fixed pupils; unconsciousness (i.e., C2 on item 1a on the NIHSS); and/or loss of other brainstem reflexes, attributable to edema or herniation according to the investigator's judgment
* With gastrointestinal bleeding and instable hemodynamics or other causes that force the patient to stop nutritional support
* Renal disorder from the patient's history (e.g., dialysis) or eGFR of \<60 mL/min/1.73 m2
* Severe liver disease, or ALT \>3 times upper limit of normal or bilirubin \>2 times normal (subjects may be randomized if liver function tests have been drawn but are not yet available and the subject has no known history of liver disease; however treatment with Study Drug cannot commence until liver function tests are available and indicate ALT \>3 times upper limit of normal and bilirubin \>2 times upper limit of normal)
* Blood glucose \<3.0 mmol/L at enrollment or immediately prior to administration of Study Drug, or a clinically significant history of hypoglycemia
* Acute ST elevation myocardial infarction, and/or acute decompensated heart failure, and/or Tc \> 520 ms, and/or known history of cardiac arrest (PEA, VT, VF, asystole), and/or admission for an acute coronary syndrome, myocardial infarction, or coronary intervention within the past 3 months
* Known sulfonylurea treatment within 7 days. Sulfonylureas include glyburide/glibenclamide; glibenclamide plus metformin; Xiaoke Pill (a Chinese patent medicine with main effective constituent of glibenclamide); glimepiride; repaglinide; nateglinide; glipizide; gliclazide; tolbutamide; glibornuride
* Known treatment with bosentan within 7 days
* Known allergy to sulfa or specific allergy to sulfonylurea drugs
* Known G6PD enzyme deficiency
* Pregnant women. Women must be either postmenopausal (as confirmed by the LAR), permanently sterilized or, if ≤50 years old must have a negative test for pregnancy obtained before enrollment
* Breast-feeding women who do not agree (or their LAR does not agree) to stop breastfeeding during Study Drug infusion and for 7 days following the end of Study Drug infusion
* Patients already enrolled in a non-observation-only stroke study, or with life-expectancy \<6 months not related to current stroke, or those unlikely to be compliant with follow up
* Patients currently receiving an investigational drug
* Mentally incompetent (prior to qualifying stroke) patients and wards of the state
* Patients who, in the opinion of the investigator, are not suitable for the study (reason to be documented)

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No