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

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Jinan University
• Treatments: Liraglutide

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.