Efficacy Study of Glucagonlike Peptide-1 to Treat Reperfusion Injury

February 4, 2016 updated by: Chen Wei Ren, MD

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

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
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • PLA General Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: liraglutide
drug: liraglutide (Novo Nordisk, Bagsværd, Denmark) duration:7 days(from admission (primary percutaneous coronary intervention) to discharge) the intervention: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
Drug: liraglutide (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
Placebo Comparator: liraglutide placebo
drug:liraglutide placebo (Novo Nordisk) duration:7 days(from admission (primary percutaneous coronary intervention) to discharge) the intervention: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
Drug: liraglutide 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the salvage index measured by cardiac magnetic resonance
Time Frame: 3 months after primary percutaneous coronary intervention
The primary endpoint was the salvage index measured by cardiac magnetic resonance after 3 months.
3 months after primary percutaneous coronary intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major adverse cardiovascular events (MACE) after 3 months
Time Frame: 3 months after Primary percutaneous coronary intervention

major 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
3 months after Primary percutaneous coronary intervention
final infarct size after 3 months
Time Frame: 3 months after Primary percutaneous coronary intervention
3 months after Primary percutaneous coronary intervention
the levels of high-sensitivity C-reactive protein (hsCRP)
Time Frame: 3 months after Primary percutaneous coronary intervention
3 months after Primary percutaneous coronary intervention
nitric oxide (NO) levels
Time Frame: 3 months after Primary percutaneous coronary intervention
3 months after Primary percutaneous coronary intervention

Collaborators and Investigators

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

Sponsor

Chen Wei Ren, MD

Investigators

  • Study Director: Yun Dai Chen, M.D., World Health Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2013

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2013-099-01
  • ChinaPLAGH (Other Identifier: ChinaPLAGH)

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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