Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus
LAMP
1 other identifier
interventional
1,708
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2019
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedStudy Start
First participant enrolled
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFebruary 6, 2023
February 1, 2023
4.4 years
May 10, 2019
February 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Percentage of patients with the 90-day new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
90 days
Percentage of patients with the 90-day Modified Rankin Scale (mRS) ≤ 2
90 days
Study Arms (2)
active
ACTIVE COMPARATORActive patients will receive liraglutide injections
standard care/no intervention
NO INTERVENTIONstandard care for stroke as per hospital protocol
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adult subjects (male or female ≥ 50 years);
- Acute ischemic stroke patients (NIHSS ≤ 3 at the time of randomization) with type 2 diabetes mellitus within 24 hours of symptoms onset;
- High-risk TIA patients (ABCD2 score ≥ 4 at the time of randomization) with type 2 diabetes mellitus within 24 hours of onset;
- First stroke, or prior stroke without sequel (mRS score ≤ 1) and does not affect the NIHSS score;
- Informed consent signed.
You may not qualify if:
- Diagnosis of hemorrhage brain disease on baseline head CT;
- Iatrogenic and cardiogenic stroke;
- Patients receiving thrombolysis or endovascular treatment;
- Use of a GLP-1 analogue or any dipeptidyl peptidase-IV (DPP-IV) inhibitor within the 3 months prior to screening;
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC);
- Patients with pancreatitis or previous history of pancreatitis, inflammatory bowel disease and gastroparesis;
- Pregnant, lactating women,or patients who are likely to have a pregnancy and plan to have one;
- Allergic to liraglutide or excipients;
- Congestive heart failure (NYHA class III-IV);
- Severe liver and kidney dysfunction (AST/ALT is 3 times higher than the normal upper limit, serum creatinine is 3 times higher than the normal upper limit);
- Patients with malignant tumors who are expected to have a survival period of less than three months;
- Participated in other clinical trials of drugs within 3 months;
- Researchers believe that patients who are not suitable for this clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Related Publications (1)
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.
PMID: 41182740DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean of the First Affiliated Hospital of Jinan University
Study Record Dates
First Submitted
May 10, 2019
First Posted
May 13, 2019
Study Start
June 25, 2019
Primary Completion
December 1, 2023
Study Completion
June 1, 2024
Last Updated
February 6, 2023
Record last verified: 2023-02