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Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus (LAMP)

Primary Purpose

Ischemic Stroke, Transient Ischemic Attack, Type 2 Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Liraglutide
Sponsored by
First Affiliated Hospital of Jinan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic stroke, transient ischemic attack, glucagon-like peptide-1, type 2 diabetes mellitus

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • The First Affiliated Hospital of Jinan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

active

standard care/no intervention

Arm Description

Active patients will receive liraglutide injections

standard care for stroke as per hospital protocol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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. No significant disability despite symptoms; able to carry out all usual duties and activities. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. Moderate disability; requiring some help, but able to walk without assistance. Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance. Severe disability, bedridden, incontinent and require constant nursing care and attention. Dead.

Full Information

First Posted
May 10, 2019
Last Updated
February 2, 2023
Sponsor
First Affiliated Hospital of Jinan University
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1. Study Identification

Unique Protocol Identification Number
NCT03948347
Brief Title
Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus
Acronym
LAMP
Official Title
Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus: A Prospective, Multicenter, Randomized, Blank-controlled，Blinded End-point Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Jinan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Transient Ischemic Attack, Type 2 Diabetes Mellitus
Keywords
ischemic stroke, transient ischemic attack, glucagon-like peptide-1, type 2 diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1708 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active
Arm Type
Active Comparator
Arm Description
Active patients will receive liraglutide injections
Arm Title
standard care/no intervention
Arm Type
No Intervention
Arm Description
standard care for stroke as per hospital protocol
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Victoza
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients with the 90-day new stroke events (ischemic or hemorrhagic)
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Percentage of patients with the 90-day new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Description
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.
Time Frame
90 days
Title
Percentage of patients with the 90-day Modified Rankin Scale (mRS) ≤ 2
Description
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. No significant disability despite symptoms; able to carry out all usual duties and activities. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. Moderate disability; requiring some help, but able to walk without assistance. Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance. Severe disability, bedridden, incontinent and require constant nursing care and attention. Dead.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anding Xu, M.D, Ph.D
Phone
+86 013392692160
Email
tlil@jnu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huili Zhu, M.D
Phone
+86 013922165588
Email
zhlffff@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anding Xu, M.D, Ph.D
Phone
+86 013392692160
Email
tlil@jnu.edu.cn
First Name & Middle Initial & Last Name & Degree
Huili Zhu, M.D
Phone
+86 013922165588
Email
zhlffff@163.com

12. IPD Sharing Statement

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Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus

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