Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With T… (NCT03948347) | Clinical Trial Compass
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Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus
China1,708 participantsStarted 2019-06-25
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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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 m…
What they're measuring
1
Percentage of patients with the 90-day new stroke events (ischemic or hemorrhagic)
Timeframe: 90 days
Trial details
NCT IDNCT03948347
SponsorFirst Affiliated Hospital of Jinan University