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出境医 / 临床实验 / Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus (LAMP)

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

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Transient Ischemic Attack Type 2 Diabetes Mellitus Drug: Liraglutide Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1708 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023
Arms and Interventions
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 Name: Victoza
No Intervention: standard care/no intervention
standard care for stroke as per hospital protocol
Outcome Measures
Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Anding Xu, M.D, Ph.D +86 013392692160 tlil@jnu.edu.cn
Contact: Huili Zhu, M.D +86 013922165588 zhlffff@163.com

Locations
Layout table for location information
China, Guangdong
The First Affiliated Hospital of Jinan University Recruiting
Guangzhou, Guangdong, China
Contact: Anding Xu, M.D, Ph.D    +86 013392692160    tlil@jnu.edu.cn   
Contact: Huili Zhu, M.D    +86 013922165588    zhlffff@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Jinan University
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE June 25, 2019
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019) 		Percentage of patients with the 90-day new stroke events [ Time Frame: 90 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • Percentage of patients with the 90-day new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) [ Time Frame: 90 days ]
  • Percentage of patients with the 90-day Modified Rankin Scale (mRS) ≤ 2 [ Time Frame: 90 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ischemic Stroke
  • Transient Ischemic Attack
  • Type 2 Diabetes Mellitus
Intervention  ICMJE 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 Name: Victoza
Study Arms  ICMJE
  • Active Comparator: active
    Active patients will receive liraglutide injections
    Intervention: Drug: Liraglutide
  • No Intervention: standard care/no intervention
    standard care for stroke as per hospital protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019) 		1708
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anding Xu, M.D, Ph.D +86 013392692160 tlil@jnu.edu.cn
Contact: Huili Zhu, M.D +86 013922165588 zhlffff@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948347
Other Study ID Numbers  ICMJE LAMP20190508
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anding Xu, First Affiliated Hospital of Jinan University
Study Sponsor  ICMJE First Affiliated Hospital of Jinan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account First Affiliated Hospital of Jinan University
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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