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NCT Number: NCT07105917

SLGT2i for Neuroprotection in Patients With Acute Ischemic Stroke

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Patients with acute ischemic stroke (AIS) within ≤ 3 days of onset, with no restrictions on reperfusion therapy
  • NIHSS score of 4-25 at the time of randomization
  • Pre-stroke mRS score ≤ 1
  • Signed informed consent form

Exclusion criteria

  • Presence of intracranial hemorrhage at the time of randomization
  • BMI ≤ 18 kg/m²
  • Severe renal insufficiency (eGFR < 30 mL/min) or severe liver impairment (Child-Pugh Class C liver function)
  • Type 1 diabetes mellitus
  • Blood glucose level < 2.7 mmol/L or > 22.2 mmol/L at the time of randomization
  • Systolic blood pressure < 95 mmHg at the time of randomization
  • History of heart failure
  • Use of SGLT-2 inhibitors within 4 weeks prior to randomization
  • Intolerance to SGLT-2 inhibitors
  • Life expectancy < 3 months
  • Pregnant or lactating women
  • Already enrolled in another clinical trial
  • Other conditions deemed inappropriate for inclusion by the investigator

Treatment and study plan

SGLT-2 inhibitors

Drug

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.

Standard Medical Treatment

Other

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).

Primary outcomes

  1. Distribution of mRS scores at 3 months

    Time frame: 3 months

Secondary outcomes

  1. Proportion of patients with mRS scores 0-1 at 3 months

    Time frame: 90 days

  2. Proportion of patients with mRS scores 0-2 at 3 months

    Time frame: 90 days

  3. Proportion of patients with mRS scores 0-3 at 3 months

    Time frame: 90 days

  4. NIHSS scores at Day 7 post-onset/at discharge

    Time frame: 7 days

  5. Change in NIHSS scores from randomization to Day 7 post-onset/at discharge

    Time frame: 7 days

  6. All-cause mortality

    Time frame: 90 days

  7. Stroke-related mortality

    Time frame: 90 days

  8. Symptomatic intracranial hemorrhage within 14 days

    Time frame: 14 days

  9. Early neurological deterioration, defined as an increase of ≥4 points in NIHSS scores from randomization to Day 7 post-onset/at discharge

    Time frame: 7 days

  10. Serious adverse events within 3 months

    Time frame: 90 days

  11. Adverse events leading to discontinuation of SGLT2i

    Time frame: 14 days

  12. Adverse events related to SGLT2i (volume depletion, renal events, severe hypoglycemic events, fractures, diabetic ketoacidosis, amputations)

    Time frame: 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Min Lou

CONTACT

[email protected]

+8615925622176

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Sodium-dependent Glucose Transporters 2 Inhibitor for Neuroprotection in Patients With Acute Ischemic Stroke

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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