SLGT2i for Neuroprotection in Patients With Acute Ischemic Stroke

Phase 3Not Yet RecruitingNCT07105917

Second Affiliated Hospital, Zhejiang University, School of Medicine1,050 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,050

Conditions

Acute Ischemic Stroke

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Distribution of mRS scores at 3 months

Time frame: 3 months

Secondary Outcomes

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

Time frame: 90 days

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

Time frame: 90 days

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

Time frame: 90 days

NIHSS scores at Day 7 post-onset/at discharge

Time frame: 7 days

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

Time frame: 7 days

All-cause mortality

Time frame: 90 days

Stroke-related mortality

Time frame: 90 days

Symptomatic intracranial hemorrhage within 14 days

Time frame: 14 days

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

Serious adverse events within 3 months

Time frame: 90 days

Adverse events leading to discontinuation of SGLT2i

Time frame: 14 days

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

Time frame: 90 days

SLGT2i for Neuroprotection in Patients With Acute Ischemic Stroke

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts