SGLT2 Inhibitor Utilization Re-perfusion Therapy

Sponsor
Taichung Veterans General Hospital
Study ID
NCT06858436
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Acute Ischemic Stroke From Large Vessel Occlusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 13, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: study group
    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.
  • No Intervention: control group
    Patients who are enrolled will be randomly assigned to either the control group. Not receiving Canagliflozin before undergoing mechanical thrombectomy.

Primary Outcome Measure

Occurrence of malignant edema [ Time Frame: On the 3rd to 5th day for MRI after EVT ]

Central Contacts

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