Safety and Efficacy of Glibenclamide Combined With Rt-PA in Acute Cerebral Embolism (SE-GRACE)

June 9, 2023 updated by: Nanfang Hospital of Southern Medical University

Safety and Efficacy of Glibenclamide Combined With Rt-PA in Treating Acute Ischemic Stroke: a Prospective, Randomized, Double-blind, Placebo-control, Multi-center Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
306

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kaibin Huang, M.D., Ph.D.
  • Phone Number: +8615915751065
  • Email: hkb@smu.edu.cn

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510515
        • Huadu District People's Hospital of Guangzhou
      • Heyuan, Guangdong, China
        • Heyuan People's Hospital
      • Maoming, Guangdong, China
        • Maoming People's Hospital
      • Maoming, Guangdong, China
        • Maoming Traditional Chinese Medical Hospital
    • Hainan
      • Haikou, Hainan, China, 570208
        • Haikou People's Hospital
      • Haikou, Hainan, China, 570100
        • Hainan Provincial Hospital of Traditional Chinese Medicine
    • Jiangsu
      • Wenzhou, Jiangsu, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Glibenclamide
Glibenclamide Tablets
Drug: 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.
Placebo Comparator: Placebo
Placebo for Glibenclamide
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points
Time Frame: 90 days after the stroke onset
The proportion of mordified Rankin Scale of 0 to 2 points at 90 days
90 days after the stroke onset

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early improvement: The proportion of NIHSS decreased ≥ 4 points
Time Frame: 7 days after the stroke onset
The proportion of NIHSS decreased ≥ 4 points at 7 days
7 days after the stroke onset
Hemorrhagic transformation: The proportion of parenchymal hemorrhagic transformation in cranial CT
Time Frame: 96 hours after the stroke onset
The proportion of parenchymal hemorrhagic transformation in cranial CT within 96 hours
96 hours after the stroke onset
Midline shift: The proportion of midline shift ≥ 6 mm in cranial CT
Time Frame: 96 hours after the stroke onset
The proportion of midline shift ≥ 6 mm in cranial CT within 96 hours
96 hours after the stroke onset
Functional outcome 2: The modified Rankin Scale distribution
Time Frame: 90 days after the stroke onset
The modified Rankin Scale distribution at 90 days
90 days after the stroke onset
Functional outcome 3: The proportion of Barthel Index of 60-100 points
Time Frame: 90 days after the stroke onset
The proportion of Barthel Index of 60-100 points
90 days after the stroke onset
Functional outcome 4: The proportion of IQCODE of ≤ 3.40
Time Frame: 6 months and 1 year after the stroke onset
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
6 months and 1 year after the stroke onset
Blood-brain barrier: The serum concentration of MMP-9
Time Frame: Baseline, 24, 48, and 72 hours after the stroke onset
The serum concentration of MMP-9 at baseline, and at 24, 48, and 72 h
Baseline, 24, 48, and 72 hours after the stroke onset

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days after the stroke onset
The mortality at 90 days
90 days after the stroke onset
Early neurological deterioration
Time Frame: 24 hours after the stroke onset
The ratio of neurological deterioration (NIHSS increased ≥ 4 points) within 24 hours after the onset
24 hours after the stroke onset
Hypoglycemia
Time Frame: 5 days after the stroke onset
The incidence of hypoglycemia (random blood glucose < 3.9 mmol/L)
5 days after the stroke onset
Cardiac events
Time Frame: 30 days after the stroke onset
The incidence of cardiac events in cardiac examination (ECG, echocardiography)
30 days after the stroke onset
Pulmonary infection
Time Frame: 7 days within the stroke onset
The incidence of pulmonary infection
7 days within the stroke onset
AEs and SAEs
Time Frame: 30 days after the stroke onset
The incidence of adverse event and serious adverse event
30 days after the stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital of Southern Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suyue Pan, M.D., Ph.D., Department of Neurology, Nanfang Hospital, Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFEC-2017-130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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