Acute Ischemic Stroke From Large Vessel OcclusionPhase 4SUPERNCT06858436
SGLT2 Inhibitor Utilization Re-perfusion Therapy
A Phase 4 study testing Canagliflozin 100mg in people with Acute Ischemic Stroke From Large Vessel Occlusion, run by Taichung Veterans General Hospital.
Trial summary
Background: Reperfusion therapies, including intravenous rt-PA and mechanical thrombectomy, significantly improve outcomes in acute ischemic stroke. However, these interventions also increase the risk of hemorrhagic transformation and malignant edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke From Large Vessel Occlusion
- What is being tested?
- Canagliflozin 100mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 13 Apr 2026to 31 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have been diagnosed with acute ischemic stroke and large vessel occlusion by a neurologist, with confirmation supported by CT perfusion scans.
- Patients must be scheduled to undergo mechanical thrombectomy.
Who cannot join
- Patients with have stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m² on dialysis)
- Patients with currently taking an SGLT2i or within 3 months prior to enrollment
- Patients with a known hypersensitivity or allergic reaction to Canagliflozin
- Patients with type 1 diabetes mellitus
- Patients with pregnancy or lactation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Role of SGLT2 Inhibitors in Stroke-reperfusion Injury:A Multi-Center, Randomized, Open-Label, Controlled Trial
Background:
Reperfusion therapies, including intravenous rt-PA and mechanical thrombectomy, significantly improve outcomes in acute ischemic stroke. However, these interventions also increase the risk of hemorrhagic transformation and malignant edema. Preclinical studies have demonstrated that Canagliflozin, an SGLT2 inhibitor, reduces astrocyte swelling and brain edema in a transient middle cerebral artery occlusion (tMCAo) model. While SGLT2 inhibitors have shown neuroprotective effects in the acute phase of ischemic stroke, their potential to mitigate hemorrhagic transformation and malignant edema following reperfusion therapy in humans remains unexamined.
Read more
Aims:
This study aims to evaluate the effect of SGLT2 inhibitors on hemorrhagic transformation and malignant edema in patients undergoing reperfusion therapy for acute ischemic stroke.
Methods:
This is a multi-center, randomized, open-label, controlled study enrolling ischemic stroke patients aged 18 years or older who meet predefined inclusion and exclusion criteria. Participants will be randomized to receive Canagliflozin 100 mg once daily for 14 days or no additional treatment before undergoing mechanical thrombectomy. Clinical data collection will include baseline demographics, medical and medication history, NIHSS scores at admission and 24 hours post-reperfusion, stroke subtype, modified Thrombolysis in Cerebral Infarction (TICI) scores, laboratory results, and modified Rankin Scale (mRS) scores at discharge and 3 months post-stroke.
The primary outcome is to assess the association between Canagliflozin use and the severity of hemorrhagic transformation and malignant edema. Hemorrhagic transformation will be classified using the Heidelberg criteria, and malignant edema will be defined as a midline shift of ≥5 mm. Brain imaging, including CT scans at 24 hours post-intervention and additional scans as clinically indicated, will be reviewed by blinded radiologists. Brain MRA will also be performed to assess infarct size and edema progression.
Importance:
This study aims to explore the potential for repurposing SGLT2 inhibitors as a therapeutic strategy in acute ischemic stroke. If Canagliflozin is shown to reduce hemorrhagic transformation and malignant edema, it could offer a novel adjunctive treatment to improve patient outcomes following reperfusion therapy.
Read the detailed description
Clinical Study Protocol The Role of SGLT2 Inhibitors in Stroke-Reperfusion Injury: A Multi-Center, Randomized, Open-Label, Controlled Trial Version 6.0 | Date: 2024-12-10
- Study Overview 1.1 Study Objectives Evaluate the efficacy of Canagliflozin 100 mg daily versus no treatment in reducing hemorrhagic transformation and malignant edema following reperfusion therapy in acute ischemic stroke.
1.2 Study Design
- Type: Multi-center, randomized, open-label, controlled trial
- Blinding: Open-label
- Randomization: Yes
- Design: Parallel-group
- Treatment Duration: 14 days
- Study Period: 3 years (2025-2027)
- Study Sites: Two medical centers in Taiwan
- Dose Adjustment: No 1.3 Endpoints
Primary Efficacy Endpoints:
- Occurrence of malignant edema
- mRS at 3 months post-stroke
- Mortality at 3 months
Secondary Efficacy Endpoints:
- Hemorrhagic transformation
- Parenchymal hematoma type 2
- NIHSS at 24 hours
- mRS at discharge
- EQ-5D at 3 months
- Infarct size on MRI
- MMP-9 upregulation after EVT
Primary Safety Endpoint:
- Incidence of adverse events (AEs)
- Study Population 2.1 Inclusion Criteria
- Age ≥18 years
- Acute ischemic stroke with large vessel occlusion, confirmed by CT perfusion
- Scheduled for mechanical thrombectomy 2.2 Exclusion Criteria
- CKD stage 4/5 (eGFR <30 mL/min/1.73m² or dialysis)
- Current or recent (≤3 months) SGLT2i use
- Hypersensitivity to Canagliflozin
- Type 1 diabetes
- Pregnancy or lactation 2.3 Withdrawal Criteria
- Voluntary withdrawal at any time
- Investigator-initiated withdrawal due to safety concerns or non-compliance
- Study Procedures
- Enrollment: ~105 patients/year (total 315 participants)
- Randomization: Canagliflozin 100 mg QD vs. control (no treatment) before thrombectomy
- Assessments:
- Pre- \& Post-EVT: Arterial blood sampling
- 24h Post-EVT: Brain dual-energy CT, NIHSS
- Day 3-Discharge: Brain MRA
- At Discharge: mRS assessment
- 3 Months Post-Stroke: mRS, EQ-5D 3.1 Imaging \& Biomarker Analysis
- Malignant Edema: Midline shift ≥5 mm or symptomatic swelling requiring decompressive craniectomy
- Hemorrhagic Transformation: Classified by Heidelberg criteria, assessed via CT at 24 hours
- Infarct Volume: Measured via MRI using the ABC/2 method
- MMP-9 Analysis: Blood collected pre-/post-EVT, analyzed via ELISA
- Safety \& Adverse Event Reporting
- Physicians will oversee patient safety and medication management.
- Participants will have direct access to study personnel for AE reporting.
- AEs will be reported to the IRB per regulatory guidelines. 4.1 Adverse Events (AE) and Management
- Hypoglycemia (~4%)
- Symptoms: Sweating, confusion, dizziness
- Management: Monitor blood glucose levels and adjust diabetes medications as needed
- Genital Infections (10-11% in women, 4% in men) o Symptoms: Itching, pain, discharge
- Management: Maintain proper hygiene and use antifungal treatments if necessary
- Urinary Tract Infections (UTIs) (~5%)
- Symptoms: Painful urination, urgency, fever
- Management: Increase fluid intake and use antibiotics if symptoms persist
- Dehydration (1-2%)
- Symptoms: Thirst, dark-colored urine, dizziness
- Management: Stay hydrated and avoid excessive intake of diuretics such as caffeine and alcohol
- Hypotension (1-2%) o Symptoms: Dizziness, fainting, fatigue o Management: Monitor blood pressure, stay hydrated, and avoid sudden posture changes
- Criteria for Trial Termination
The trial may be stopped if:
- Safety concerns: Unexpected SAEs or high AE incidence outweighs benefits
- Regulatory issues: Recommendations from IRB/DSMB
- Operational issues: Insufficient enrollment or funding
- Interim analysis: Evidence of harm or lack of benefit
- Statistical Considerations 6.1 Sample Size
- Total required: 314 participants (157 per group)
- Power: 80%
- Alpha: 0.1 (one-sided) 6.2 Statistical Analysis
- Categorical Data: Fisher's exact test or χ² test
- Continuous Data: Mann-Whitney U-test, independent t-test
- Kaplan-Meier plots: Cumulative risk analysis
- Cox Proportional-Hazards Model: Malignant edema \& hemorrhagic transformation incidence
- Repeated Measures ANOVA: NIHSS score changes
- Significance:
- p < 0.1 (*); p < 0.05 (**) 6.3 Population for Analysis
- Intent-to-treat (ITT) for efficacy \& safety assessments 6.4 Data Handling
- Poor-quality/missing data will be excluded.
- Protocol deviations will be documented and justified.
- Ethical \& Regulatory Considerations 7.1 Ethical Approval \& Patient Rights
- IRB Approval: Required before initiation
- Informed Consent: Participants will receive detailed study information and can withdraw at any time
- Data Security: Encrypted storage at two hospitals, access restricted to investigators 7.2 Data Access
- IRB permitted access for monitoring, audits, and inspections
- Funding \& Insurance
- Funding: Provided by Veterans General Hospital
- Insurance: Coverage provided for participants due to study interventions
- References Key literature supporting Canagliflozin's neuroprotective potential in ischemic stroke and reperfusion injury.
- Being tested
- Canagliflozin 100mg
- Keywords
- reperfusion therapy, SGLT2 inhibitor, malignant edema and transformation hemorrhage
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin 100mgDrug
Also called Canagliflozin
receiving Canagliflozin 100mg QD
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Patients who are enrolled will be randomly assigned to either the study group. Receiving Canagliflozin 100mg QD before undergoing mechanical thrombectomy. The prescribed duration of Canagliflozin 100mg QD will be 14 days. Receives: Drug: Canagliflozin 100mg |
| control group | No intervention | Patients who are enrolled will be randomly assigned to either the control group. Not receiving Canagliflozin before undergoing mechanical thrombectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of malignant edema
Diagnosed if midline shift ≥5 mm on brain imaging or symptomatic brain swelling requiring decompressive craniectomy, leading to in-hospital death, or coma at discharge.
Measured: On the 3rd to 5th day for MRI after EVT
mRS at 3rd month after stroke onset
Assesses health-related quality of life using modified Rankin Scale (mRS) to assess disability level post-stroke for understanding the recovery situation of the patient.
Measured: 3 months after stroke onset
Mortality rate at 3rd month after stroke onset
To understand if the patient is surviving or not after stroke onset.
Measured: After stroke onset in 3 months.
Secondary outcomes (7)
Occurrence of hemorrhagic transformation
Classified using the Heidelberg criteria to categorize hemorrhagic changes post-EVT.
Measured: During hospitalization for 14 days
Occurrence f parenchymal hematoma type2
Identified based on brain imaging and classified using the Heidelberg criteria, indicating severe hemorrhagic transformation.
Measured: During hospitalization for 14 days
NIHSS 24 hours later
Neurological status assessed using National Institutes of Health Stroke Scale (NIHSS) to measure stroke severity and potential deterioration by neurologist.
Measured: 24 hours after EVT
mRS at discharge
Functional outcome evaluated using modified Rankin Scale (mRS) to assess disability level post-stroke.
Measured: Day 14 at hospital discharge
EQ-5D at 3rd month after stroke onset
EQ-5D will be assessed three months after the onset of stroke through either face-to-face interviews or virtual platforms. Assesses health-related quality of life for understanding the recovery situation of the patient.
Measured: 3 months after stroke onset
infarct size on brain MRI
Measured using diffusion-weighted imaging (DWI), defined as a hyperintense area on b = 1000 mm/s² images.
Calculation Method: ABC/2 method for infarct volume quantification.
Measured: Day 1 after EVT
upregulation of arterial biomarkers (MMP-9) after EVT
Arterial blood will be collected from the puncture site, in a BD Vacutainer® EDTA tube, before and after EVT and centrifuged at 1,500 × g for 15 min at 4°C. The supernatant was collected as blood plasma. The level of MMP-9 in the plasma was measured following the manufacturer's protocol for the human MMP-9 Quantikine ELISA kit.
Measured: Day 1 before EVT is executed and after EVT finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start13 Apr 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke From Large Vessel OcclusionStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Po-Lin Chen, Taichung Veterans General Hospital
- Investigators
- Po-Lin Chen, Study director, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858436
- Sponsor's protocol ID
- TCVGH-1134501F
- Acronym
- SUPER
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of SGLT2 Inhibitors in Stroke-reperfusion Injury:A Multi-Center, Randomized, Open-Label, Controlled Trial
- ClinicalTrials.gov ID
- NCT06858436
- Acronym / sponsor ID
- SUPER / TCVGH-1134501F
- Keywords
- reperfusion therapy, SGLT2 inhibitor, malignant edema and transformation hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 5 Mar 2025 (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.
Background:
Reperfusion therapies, including intravenous rt-PA and mechanical thrombectomy, significantly improve outcomes in acute ischemic stroke. However, these interventions also increase the risk of hemorrhagic transformation and malignant edema. Preclinical studies have demonstrated that Canagliflozin, an SGLT2 inhibitor, reduces astrocyte swelling and brain edema in a transient middle cerebral artery occlusion (tMCAo) model. While SGLT2 inhibitors have shown neuroprotective effects in the acute phase of ischemic stroke, their potential to mitigate hemorrhagic transformation and malignant edema following reperfusion therapy in humans remains unexamined.
Aims:
This study aims to evaluate the effect of SGLT2 inhibitors on hemorrhagic transformation and malignant edema in patients undergoing reperfusion therapy for acute ischemic stroke.
Methods:
This is a multi-center, randomized, open-label, controlled study enrolling ischemic stroke patients aged 18 years or older who meet predefined inclusion and exclusion criteria. Participants will be randomized to receive Canagliflozin 100 mg once daily for 14 days or no additional treatment before undergoing mechanical thrombectomy. Clinical data collection will include baseline demographics, medical and medication history, NIHSS scores at admission and 24 hours post-reperfusion, stroke subtype, modified Thrombolysis in Cerebral Infarction (TICI) scores, laboratory results, and modified Rankin Scale (mRS) scores at discharge and 3 months post-stroke.
The primary outcome is to assess the association between Canagliflozin use and the severity of hemorrhagic transformation and malignant edema. Hemorrhagic transformation will be classified using the Heidelberg criteria, and malignant edema will be defined as a midline shift of ≥5 mm. Brain imaging, including CT scans at 24 hours post-intervention and additional scans as clinically indicated, will be reviewed by blinded radiologists. Brain MRA will also be performed to assess infarct size and edema progression.
Importance:
This study aims to explore the potential for repurposing SGLT2 inhibitors as a therapeutic strategy in acute ischemic stroke. If Canagliflozin is shown to reduce hemorrhagic transformation and malignant edema, it could offer a novel adjunctive treatment to improve patient outcomes following reperfusion therapy.
Detailed description
Clinical Study Protocol The Role of SGLT2 Inhibitors in Stroke-Reperfusion Injury: A Multi-Center, Randomized, Open-Label, Controlled Trial Version 6.0 | Date: 2024-12-10
- Study Overview 1.1 Study Objectives Evaluate the efficacy of Canagliflozin 100 mg daily versus no treatment in reducing hemorrhagic transformation and malignant edema following reperfusion therapy in acute ischemic stroke.
1.2 Study Design
- Type: Multi-center, randomized, open-label, controlled trial
- Blinding: Open-label
- Randomization: Yes
- Design: Parallel-group
- Treatment Duration: 14 days
- Study Period: 3 years (2025-2027)
- Study Sites: Two medical centers in Taiwan
- Dose Adjustment: No 1.3 Endpoints
Primary Efficacy Endpoints:
- Occurrence of malignant edema
- mRS at 3 months post-stroke
- Mortality at 3 months
Secondary Efficacy Endpoints:
- Hemorrhagic transformation
- Parenchymal hematoma type 2
- NIHSS at 24 hours
- mRS at discharge
- EQ-5D at 3 months
- Infarct size on MRI
- MMP-9 upregulation after EVT
Primary Safety Endpoint:
- Incidence of adverse events (AEs)
- Study Population 2.1 Inclusion Criteria
- Age ≥18 years
- Acute ischemic stroke with large vessel occlusion, confirmed by CT perfusion
- Scheduled for mechanical thrombectomy 2.2 Exclusion Criteria
- CKD stage 4/5 (eGFR <30 mL/min/1.73m² or dialysis)
- Current or recent (≤3 months) SGLT2i use
- Hypersensitivity to Canagliflozin
- Type 1 diabetes
- Pregnancy or lactation 2.3 Withdrawal Criteria
- Voluntary withdrawal at any time
- Investigator-initiated withdrawal due to safety concerns or non-compliance
- Study Procedures
- Enrollment: ~105 patients/year (total 315 participants)
- Randomization: Canagliflozin 100 mg QD vs. control (no treatment) before thrombectomy
- Assessments:
- Pre- \& Post-EVT: Arterial blood sampling
- 24h Post-EVT: Brain dual-energy CT, NIHSS
- Day 3-Discharge: Brain MRA
- At Discharge: mRS assessment
- 3 Months Post-Stroke: mRS, EQ-5D 3.1 Imaging \& Biomarker Analysis
- Malignant Edema: Midline shift ≥5 mm or symptomatic swelling requiring decompressive craniectomy
- Hemorrhagic Transformation: Classified by Heidelberg criteria, assessed via CT at 24 hours
- Infarct Volume: Measured via MRI using the ABC/2 method
- MMP-9 Analysis: Blood collected pre-/post-EVT, analyzed via ELISA
- Safety \& Adverse Event Reporting
- Physicians will oversee patient safety and medication management.
- Participants will have direct access to study personnel for AE reporting.
- AEs will be reported to the IRB per regulatory guidelines. 4.1 Adverse Events (AE) and Management
- Hypoglycemia (~4%)
- Symptoms: Sweating, confusion, dizziness
- Management: Monitor blood glucose levels and adjust diabetes medications as needed
- Genital Infections (10-11% in women, 4% in men) o Symptoms: Itching, pain, discharge
- Management: Maintain proper hygiene and use antifungal treatments if necessary
- Urinary Tract Infections (UTIs) (~5%)
- Symptoms: Painful urination, urgency, fever
- Management: Increase fluid intake and use antibiotics if symptoms persist
- Dehydration (1-2%)
- Symptoms: Thirst, dark-colored urine, dizziness
- Management: Stay hydrated and avoid excessive intake of diuretics such as caffeine and alcohol
- Hypotension (1-2%) o Symptoms: Dizziness, fainting, fatigue o Management: Monitor blood pressure, stay hydrated, and avoid sudden posture changes
- Criteria for Trial Termination
The trial may be stopped if:
- Safety concerns: Unexpected SAEs or high AE incidence outweighs benefits
- Regulatory issues: Recommendations from IRB/DSMB
- Operational issues: Insufficient enrollment or funding
- Interim analysis: Evidence of harm or lack of benefit
- Statistical Considerations 6.1 Sample Size
- Total required: 314 participants (157 per group)
- Power: 80%
- Alpha: 0.1 (one-sided) 6.2 Statistical Analysis
- Categorical Data: Fisher's exact test or χ² test
- Continuous Data: Mann-Whitney U-test, independent t-test
- Kaplan-Meier plots: Cumulative risk analysis
- Cox Proportional-Hazards Model: Malignant edema \& hemorrhagic transformation incidence
- Repeated Measures ANOVA: NIHSS score changes
- Significance:
- p < 0.1 (*); p < 0.05 (**) 6.3 Population for Analysis
- Intent-to-treat (ITT) for efficacy \& safety assessments 6.4 Data Handling
- Poor-quality/missing data will be excluded.
- Protocol deviations will be documented and justified.
- Ethical \& Regulatory Considerations 7.1 Ethical Approval \& Patient Rights
- IRB Approval: Required before initiation
- Informed Consent: Participants will receive detailed study information and can withdraw at any time
- Data Security: Encrypted storage at two hospitals, access restricted to investigators 7.2 Data Access
- IRB permitted access for monitoring, audits, and inspections
- Funding \& Insurance
- Funding: Provided by Veterans General Hospital
- Insurance: Coverage provided for participants due to study interventions
- References Key literature supporting Canagliflozin's neuroprotective potential in ischemic stroke and reperfusion injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Canagliflozin 100mgPatients who are enrolled will be randomly assigned to either the study group. Receiving Canagliflozin 100mg QD before undergoing mechanical thrombectomy. The prescribed duration of Canagliflozin 100mg QD will be 14 days. |
| control group | No intervention | –Patients who are enrolled will be randomly assigned to either the control group. Not receiving Canagliflozin before undergoing mechanical thrombectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have been diagnosed with acute ischemic stroke and large vessel occlusion by a neurologist, with confirmation supported by CT perfusion scans.
- Patients must be scheduled to undergo mechanical thrombectomy.
Key exclusion criteria (5 listed)
- Patients with have stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m² on dialysis)
- Patients with currently taking an SGLT2i or within 3 months prior to enrollment
- Patients with a known hypersensitivity or allergic reaction to Canagliflozin
- Patients with type 1 diabetes mellitus
- Patients with pregnancy or lactation
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 |
|---|---|---|
| Canagliflozin 100mgAlso: Canagliflozinreceiving Canagliflozin 100mg QD | Drug | study group |
Primary outcome
Occurrence of malignant edema
Time frame: On the 3rd to 5th day for MRI after EVT
Diagnosed if midline shift ≥5 mm on brain imaging or symptomatic brain swelling requiring decompressive craniectomy, leading to in-hospital death, or coma at discharge.
mRS at 3rd month after stroke onset
Time frame: 3 months after stroke onset
Assesses health-related quality of life using modified Rankin Scale (mRS) to assess disability level post-stroke for understanding the recovery situation of the patient.
Mortality rate at 3rd month after stroke onset
Time frame: After stroke onset in 3 months.
To understand if the patient is surviving or not after stroke onset.
7 secondary outcomes
Occurrence of hemorrhagic transformation
Time frame: During hospitalization for 14 days
Occurrence f parenchymal hematoma type2
Time frame: During hospitalization for 14 days
NIHSS 24 hours later
Time frame: 24 hours after EVT
mRS at discharge
Time frame: Day 14 at hospital discharge
EQ-5D at 3rd month after stroke onset
Time frame: 3 months after stroke onset
infarct size on brain MRI
Time frame: Day 1 after EVT
upregulation of arterial biomarkers (MMP-9) after EVT
Time frame: Day 1 before EVT is executed and after EVT finished
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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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.
Po-Lin Chen study director
Taichung Veterans General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Canagliflozin 100mg in people with Acute Ischemic Stroke From Large Vessel Occlusion, run by Taichung Veterans General Hospital.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Po-Lin Chen (+886 23592525 ext. 3022, boring@mail2000.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of malignant edema (time frame: On the 3rd to 5th day for MRI after EVT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.