SGLT2 Inhibitor Utilization Re-perfusion Therapy

NCT06858436 | Not Yet Recruiting Phase 4

• 1 other identifier: TCVGH-1134501F
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Acute Ischemic Stroke From Large Vessel Occlusion

Keywords

reperfusion therapy; SGLT2 inhibitor; malignant edema and transformation hemorrhage

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  After stroke onset in 3 months.

Secondary Outcomes (7)

• Occurrence of hemorrhagic transformation

  During hospitalization for 14 days

• Occurrence f parenchymal hematoma type2

  During hospitalization for 14 days

• NIHSS 24 hours later

  24 hours after EVT

• mRS at discharge

  Day 14 at hospital discharge

• EQ-5D at 3rd month after stroke onset

  3 months after stroke onset

Other Outcomes (1)

• Occurrence of adverse events as assessed by CTCAE v5.0

  During hospitalization for 14 days

Study Arms (2)

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.

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.

Interventions

Canagliflozin 100mg DRUG

receiving Canagliflozin 100mg QD

Also known as: Canagliflozin

study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

MeSH Terms

Conditions

Anthrax

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Po-Lin Chen

  Taichung Veterans General Hospital

  STUDY DIRECTOR

Central Study Contacts

Po-Lin Chen

CONTACT

+886 23592525; boring@mail2000.com.tw

Yu-Hsuan Wu

CONTACT

+886 23592525; willie900811@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: March 5, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01