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

February 2, 2023 updated by: Anding Xu, First Affiliated Hospital of Jinan University

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1708

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Jinan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: active
Active patients will receive liraglutide injections
Drug: Liraglutide
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.
Other Names:
  • Victoza
NO_INTERVENTION: standard care/no intervention
standard care for stroke as per hospital protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with the 90-day new stroke events (ischemic or hemorrhagic)
Time Frame: 90 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with the 90-day new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Time Frame: 90 days

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.
90 days
Percentage of patients with the 90-day Modified Rankin Scale (mRS) ≤ 2
Time Frame: 90 days

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Jinan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 25, 2019

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

June 1, 2024

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (ACTUAL)

May 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAMP20190508

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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