Sodium-dependent Glucose Transporters 2 Inhibitor for Neuroprotection in Patients With Acute Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,050
- 主要终点
- Distribution of mRS scores at 3 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard therapy
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).
干预措施: Standard medical treatment (Other)
Experimental: SGLT2i with standard therapy
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.
干预措施: SGLT-2 inhibitors (Drug)
结局指标
主要结局
Distribution of mRS scores at 3 months
时间窗: 3 months
次要结局
- 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)
- 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)
- Serious adverse events within 3 months(90 days)
- Adverse events leading to discontinuation of SGLT2i(14 days)
- Adverse events related to SGLT2i (volume depletion, renal events, severe hypoglycemic events, fractures, diabetic ketoacidosis, amputations)(90 days)
研究者
Min Lou
Principal Investigator
Second Affiliated Hospital, School of Medicine, Zhejiang University