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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: SGLT2i with standard therapy | Experimental | 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. |
|
| Standard therapy | Sham Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT-2 inhibitors | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of mRS scores at 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Lou | Contact | +8615925622176 | lm99@zju.edu.cn |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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|
| Standard medical treatment | Other | 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). |
|
| 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 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D045505 | Physiological Effects of Drugs |