SLGT2i for Neuroprotection in Patients With Acute Ischemic Stroke

NCT07105917 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1050

Last updated 2025-08-11

No results posted yet for this study

Summary

Stroke is a leading cause of disability and mortality globally. With population aging, ischemic stroke (80% of cases) has become China's primary cause of adult disability. Sodium-dependent glucose transporters 2 inhibitors (SGLT2i) demonstrate cardiovascular protection beyond glycemic control, even in patients without diabetes.

Preclinical studies suggest neuroprotective effects via improving cerebral glucose metabolism, anti-inflammatory/antioxidant actions, and reducing neuronal apoptosis. Therefore, the investigators aim to evaluate whether SGLT2i could improve 3-month functional outcomes (mRS scores) in AIS patients compared to standard care.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

SGLT-2 inhibitors

Any of the following SGLT2 inhibitors (SGLT2i) can be selected for treatment: Dapagliflozin 10 mg once daily (QD) or Empagliflozin 10 mg once daily (QD) If the patient has concurrent diabetes, the use of other antidiabetic drugs is not restricted. The treatment should last for at least 14 days.

OTHER

Standard medical treatment

According to the guideline-recommended standard treatment, if the patient has diabetes, there is no restriction on the use of other antidiabetic drugs (except SGLT-2 inhibitors).

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-08-01
Completion
2026-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07105917 on ClinicalTrials.gov