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The purpose of this study is to assess the safety and efficacy of glucagon-like peptide-1 (GLP-1) analogue liraglutide in the treatment of acute minor stroke (National Institute of Health stroke scale, NIHSS ≤ 3) or high-risk transient ischemic attack (TIA) (ABCD2 score ≥ 4 ) patients with type 2 diabetes mellitus.
The treatment arm will receive the starting dose of liraglutide of 0.6mg/d subcutaneously once daily, and the dose will be increased to 1.8mg/d in two weeks, and then continue to administrate this dose for 90 days. The control arm will not use liraglutide. Other types of GLP-1 analogues or degraded by dipeptidyl peptidase-IV (DPP-IV) inhibitors will be prohibited. Study visits will be performed at day 7, day 30±3 and at 90±7 day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active | Active Comparator | Active patients will receive liraglutide injections |
|
| standard care/no intervention | No Intervention | standard care for stroke as per hospital protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | The treatment arm will receive the starting dose of liraglutide of 0.6 mg/d subcutaneously once daily, and the dose will be increased to 1.8 mg/d in two weeks, and then continue to administrate this dose for 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with the 90-day new stroke events (ischemic or hemorrhagic) | Definition of ischemic stroke: An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction. Either of the following is considered to be an ischemic stroke: a new focal neurologic deficit lasting for less than 24 hours and not attributable to a nonischemic cause but accompanied by neuroimaging evidence of new brain infarction; sudden onset of a new focal neurologic deficit, with clinical or imaging evidence of infarction lasting 24 hours or more and not attributable to a nonischemic cause. Definition of hemorrhagic stroke: Rapidly developing clinical signs of neurological dysfunction attributable to a focal collection of blood within the brain parenchyma, ventricular system or subarachnoid space that is not caused by trauma. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with the 90-day new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) | Transient ischemic attack was defined as transient neurological deficits caused by focal brain or retinal ischemia, the clinical symptoms are generally no more than 1 hour, and the longest duration is less than 24 hours, and there is no evidence of a responsible lesion. The clinical definition of myocardial infarction denotes the presence of acute myocardial injury detected by abnormal cardiac biomarkers in the setting of evidence of acute myocardial ischemia. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anding Xu, M.D, Ph.D | Contact | +86 013392692160 | tlil@jnu.edu.cn | |
| Huili Zhu, M.D | Contact | +86 013922165588 | zhlffff@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Jinan University | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42145088 | Derived | Lu L, Yang B, Wang Y, Zhu C, Liu Z, Li F, Yang S, Liu Y, Yang Y, Liu X, Huang L, Xu A, Zhu H. Liraglutide and Recurrent Stroke by Baseline Insulin Resistance: A Post Hoc Analysis of the LAMP Trial. Stroke. 2026 May 18. doi: 10.1161/STROKEAHA.125.056010. Online ahead of print. | |
| 41182740 | Derived | Zhu H, Yang B, Lu L, Li Y, Sui R, Liu K, Tan S, Wang L, Qiu J, Zhong J, Wei T, Bei Y, Huang J, Zhang S, Ji Y, Wu W, Li Y, Huang Y, Chen Y, Huang X, Zeng G, Zhang Y, Huang L, Li H, Wang X, Wang Y, Xu A; LAMP Investigators. Liraglutide in Acute Minor Ischemic Stroke or High-Risk Transient Ischemic Attack With Type 2 Diabetes: The LAMP Randomized Clinical Trial. JAMA Intern Med. 2026 Jan 1;186(1):46-54. doi: 10.1001/jamainternmed.2025.5684. |
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|
| 90 days |
| Percentage of patients with the 90-day Modified Rankin Scale (mRS) ≤ 2 | The modified Rankin scale is used to measure the recovery of neurological function in patients after stroke. The following questionnaire will be used to determine the mRs score: The modified Rankin scale is used to measure the recovery of neurological function in patients after stroke. The following questionnaire will be used to determine the mRs score: 0- No symptoms at all.
| 90 days |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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