SLGT2i for Neuroprotection in Patients With Acute Ischemic Stroke

Official title

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

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.

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).

Primary outcome measures

• Distribution of mRS scores at 3 months [Time frame: 3 months]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07105917 · SNPS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗