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Efficacy Study of Glucagonlike Peptide-1 to Treat Reperfusion Injury

Protective Effect of Glucagonlike Peptide-1 on Reperfusion Injury in Patients With Acute Myocardial Infarction

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02001363
Enrollment
90
Registered
2013-12-04
Start date
2013-11-30
Completion date
2016-03-31
Last updated
2016-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Reperfusion injury, Liraglutide

Brief summary

The investigators planned to research the cardioprotective effects of intravenous liraglutide on reperfusion injury.

Detailed description

Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (pPCI) is currently the most effective treatment strategy in acute myocardial infarction. However, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and recently GLP-1 analogues have been introduced for the treatment of type-2 diabetes. In experimental studies, GLP-1 or its analogues protect against reperfusion injury-induced cell death. Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction. Liraglutide(GLP-1) is safe and effective to reduce weight,serum lipid levels and blood pressure. Liraglutide can reduce cardiac rupture (12 of 60 versus 46 of 60; P=0.0001) and infarct size (21±2% versus 29±3%, P=0.02) and improved cardiac output (12.4±0.6 versus 9.7±0.6 ml/min; P=0.002) in normal and diabetic mice. The investigators planned to research the cardioprotective effects of intravenous liraglutide administered prior to reperfusion and continued after restoration of coronary blood flow in patients with STEMI undergoing pPCI.

Interventions

DRUGliraglutide placebo (Novo Nordisk)

once-daily subcutaneous liraglutide placebo 0.6 mg for 2 days, then gradually increase the dosage, once-daily subcutaneous liraglutide placebo 1.2 mg for 2 days ,once-daily subcutaneous liraglutide placebo 1.8 mg for 3 days

DRUGliraglutide (Novo Nordisk, Bagsværd, Denmark)

once-daily subcutaneous liraglutide 0.6 mg for 2 days, then gradually increase the dosage, once-daily subcutaneous liraglutide 1.2 mg for 2 days ,once-daily subcutaneous liraglutide 1.8 mg for 3 days

Sponsors

Chen Wei Ren, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients were eligible if they were 18 years or older and presented within 12 h from the onset of symptoms and signs of ST-segment elevation myocardial infarction to the catheterization laboratory.

Exclusion criteria

The patients were not considered for enrolment if they presented with unconsciousness, cardiogenic shock, hypoglycaemia, diabetic ketoacidosis, previous myocardial infarction, stent thrombosis, known renal insufficiency, or previous coronary artery bypass operation.

Design outcomes

Primary

MeasureTime frameDescription
the salvage index measured by cardiac magnetic resonance3 months after primary percutaneous coronary interventionThe primary endpoint was the salvage index measured by cardiac magnetic resonance after 3 months.

Secondary

MeasureTime frameDescription
major adverse cardiovascular events (MACE) after 3 months3 months after Primary percutaneous coronary interventionmajor adverse cardiovascular events (MACE) after 3 months: recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death. treatment-emergent adverse events (TEAEs): hypoglycemia, nausea, acute pancreatitis
final infarct size after 3 months3 months after Primary percutaneous coronary intervention
the levels of high-sensitivity C-reactive protein (hsCRP)3 months after Primary percutaneous coronary intervention
nitric oxide (NO) levels3 months after Primary percutaneous coronary intervention

Countries

China

Contacts

Primary ContactWei Ren Chen, M.D.
chen_weiren@sina.com+8610-66939709

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026