SLGT2i for Neuroprotection in Patients With Acute Ischemic Stroke

Zhejiang University

Status and phase: Not yet enrolling; Phase 3

Conditions: Acute Ischemic Stroke

Treatments: Other: Standard medical treatment; Drug: SGLT-2 inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT07105917

SNPS

Details and patient eligibility

About

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.

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,050 participants in 2 patient groups

Experimental: SGLT2i with standard therapy

Experimental group

Description:

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.

Treatment:

Drug: SGLT-2 inhibitors

Standard therapy

Sham Comparator group

Description:

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).

Treatment:

Other: Standard medical treatment