Acute Ischemic Stroke
Conditions
Brief 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.
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.
OTHERStandard 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
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distribution of mRS scores at 3 months | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in NIHSS scores from randomization to Day 7 post-onset/at discharge | 7 days |
| All-cause mortality | 90 days |
| Stroke-related mortality | 90 days |
| Symptomatic intracranial hemorrhage within 14 days | 14 days |
| Early neurological deterioration, defined as an increase of ≥4 points in NIHSS scores from randomization to Day 7 post-onset/at discharge | 7 days |
| Adverse events related to SGLT2i (volume depletion, renal events, severe hypoglycemic events, fractures, diabetic ketoacidosis, amputations) | 90 days |
| Adverse events leading to discontinuation of SGLT2i | 14 days |
| Proportion of patients with mRS scores 0-1 at 3 months | 90 days |
| Proportion of patients with mRS scores 0-2 at 3 months | 90 days |
| Proportion of patients with mRS scores 0-3 at 3 months | 90 days |
| NIHSS scores at Day 7 post-onset/at discharge | 7 days |
| Serious adverse events within 3 months | 90 days |
Contacts
Primary ContactMin Lou
Outcome results
None listed