A Phase 4 interventional study of Canagliflozin 100mg in Acute Ischemic Stroke From Large Vessel Occlusion, sponsored by Taichung Veterans General Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Taichung Veterans General Hospital · Phase 4, Interventional, and Treatment
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.
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
1. 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
Primary Efficacy Endpoints:
Secondary Efficacy Endpoints:
Primary Safety Endpoint:
Incidence of adverse events (AEs)
2. Study Population 2.1 Inclusion Criteria
Investigator-initiated withdrawal due to safety concerns or non-compliance
3. Study Procedures
Assessments:
o Pre- \& Post-EVT: Arterial blood sampling
MMP-9 Analysis: Blood collected pre-/post-EVT, analyzed via ELISA
4. Safety \& Adverse Event Reporting
AEs will be reported to the IRB per regulatory guidelines. 4.1 Adverse Events (AE) and Management
Hypoglycemia (\~4%)
Genital Infections (10-11% in women, 4% in men) o Symptoms: Itching, pain, discharge
o Management: Maintain proper hygiene and use antifungal treatments if necessary
Urinary Tract Infections (UTIs) (\~5%)
o Symptoms: Painful urination, urgency, fever
o Management: Increase fluid intake and use antibiotics if symptoms persist
Dehydration (1-2%)
o Symptoms: Thirst, dark-colored urine, dizziness
o Management: Stay hydrated and avoid excessive intake of diuretics such as caffeine and alcohol
5. Criteria for Trial Termination
The trial may be stopped if:
Interim analysis: Evidence of harm or lack of benefit
6. Statistical Considerations 6.1 Sample Size
Significance:
o p \< 0.1 (*); p \< 0.05 (**) 6.3 Population for Analysis
Protocol deviations will be documented and justified.
7. Ethical \& Regulatory Considerations 7.1 Ethical Approval \& Patient Rights
IRB permitted access for monitoring, audits, and inspections
8. Funding \& Insurance
Insurance: Coverage provided for participants due to study interventions
9. References Key literature supporting Canagliflozin's neuroprotective potential in ischemic stroke and reperfusion injury.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 57 interventional studies indexed under Anthrax.
Browse Anthrax studies →Taichung Veterans General Hospital is the lead sponsor of 175 studies on the registry; 39 are open to participants now.
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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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Canagliflozin 100mg
Patients who are enrolled will be randomly assigned to either the control group. Not receiving Canagliflozin before undergoing mechanical thrombectomy.
receiving Canagliflozin 100mg QD
Also known as: Canagliflozin
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.
Time frame: 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.
Time frame: 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.
Time frame: After stroke onset in 3 months.
Occurrence of hemorrhagic transformation
Classified using the Heidelberg criteria to categorize hemorrhagic changes post-EVT.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after EVT
mRS at discharge
Functional outcome evaluated using modified Rankin Scale (mRS) to assess disability level post-stroke.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 before EVT is executed and after EVT finished
Occurrence of adverse events as assessed by CTCAE v5.0
To understand if the patient have any occurrence of AE or SAE during the session. The result of finding any of the diseases listed on the CTCAE v5.0 will be reported to IRB of Taichung Veterans General Hospital.
Time frame: During hospitalization for 14 days
No study locations are listed for this record.
Start is estimated for Apr 2026; primary completion for Oct 2027, 18 months later.
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Canagliflozin
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