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Efficacy Study of Glucagonlike Peptide-1 to Treat Reperfusion Injury

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
liraglutide (Novo Nordisk, Bagsværd, Denmark)
liraglutide placebo (Novo Nordisk)
Sponsored by
Chen Wei Ren, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Reperfusion injury, Liraglutide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

liraglutide

liraglutide placebo

Arm Description

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 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

Outcomes

Primary Outcome Measures

the salvage index measured by cardiac magnetic resonance
The primary endpoint was the salvage index measured by cardiac magnetic resonance after 3 months.

Secondary Outcome Measures

major adverse cardiovascular events (MACE) after 3 months
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
final infarct size after 3 months
the levels of high-sensitivity C-reactive protein (hsCRP)
nitric oxide (NO) levels

Full Information

First Posted
November 27, 2013
Last Updated
February 4, 2016
Sponsor
Chen Wei Ren, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02001363
Brief Title
Efficacy Study of Glucagonlike Peptide-1 to Treat Reperfusion Injury
Official Title
Protective Effect of Glucagonlike Peptide-1 on Reperfusion Injury in Patients With Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chen Wei Ren, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Reperfusion injury, Liraglutide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
liraglutide
Arm Type
Experimental
Arm Description
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
Arm Title
liraglutide placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
liraglutide (Novo Nordisk, Bagsværd, Denmark)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
liraglutide placebo (Novo Nordisk)
Intervention Description
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
Primary Outcome Measure Information:
Title
the salvage index measured by cardiac magnetic resonance
Description
The primary endpoint was the salvage index measured by cardiac magnetic resonance after 3 months.
Time Frame
3 months after primary percutaneous coronary intervention
Secondary Outcome Measure Information:
Title
major adverse cardiovascular events (MACE) after 3 months
Description
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
Time Frame
3 months after Primary percutaneous coronary intervention
Title
final infarct size after 3 months
Time Frame
3 months after Primary percutaneous coronary intervention
Title
the levels of high-sensitivity C-reactive protein (hsCRP)
Time Frame
3 months after Primary percutaneous coronary intervention
Title
nitric oxide (NO) levels
Time Frame
3 months after Primary percutaneous coronary intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Ren Chen, M.D.
Phone
+8610-66939709
Email
chen_weiren@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Dai Chen, M.D.
Organizational Affiliation
World Health Organization
Official's Role
Study Director
Facility Information:
Facility Name
PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Ren Chen, M.D.
Phone
+8610-66939709
Email
chen_weiren@sina.com
First Name & Middle Initial & Last Name & Degree
Yun Dai Chen, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
18819705
Citation
Garber A, Henry R, Ratner R, Garcia-Hernandez PA, Rodriguez-Pattzi H, Olvera-Alvarez I, Hale PM, Zdravkovic M, Bode B; LEAD-3 (Mono) Study Group. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009 Feb 7;373(9662):473-81. doi: 10.1016/S0140-6736(08)61246-5. Epub 2008 Sep 24.
Results Reference
background
PubMed Identifier
21920963
Citation
Lonborg J, Vejlstrup N, Kelbaek H, Botker HE, Kim WY, Mathiasen AB, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Thuesen L, Krusell LR, Jensen JS, Kober L, Treiman M, Holst JJ, Engstrom T. Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2012 Jun;33(12):1491-9. doi: 10.1093/eurheartj/ehr309. Epub 2011 Sep 14.
Results Reference
background
PubMed Identifier
19136619
Citation
Liu H, Dear AE, Knudsen LB, Simpson RW. A long-acting glucagon-like peptide-1 analogue attenuates induction of plasminogen activator inhibitor type-1 and vascular adhesion molecules. J Endocrinol. 2009 Apr;201(1):59-66. doi: 10.1677/JOE-08-0468. Epub 2009 Jan 9.
Results Reference
background
PubMed Identifier
19151200
Citation
Noyan-Ashraf MH, Momen MA, Ban K, Sadi AM, Zhou YQ, Riazi AM, Baggio LL, Henkelman RM, Husain M, Drucker DJ. GLP-1R agonist liraglutide activates cytoprotective pathways and improves outcomes after experimental myocardial infarction in mice. Diabetes. 2009 Apr;58(4):975-83. doi: 10.2337/db08-1193. Epub 2009 Jan 16.
Results Reference
result
PubMed Identifier
28286967
Citation
Huang M, Wei R, Wang Y, Su T, Li Q, Yang X, Chen X. Protective effect of glucagon-like peptide-1 agents on reperfusion injury for acute myocardial infarction: a meta-analysis of randomized controlled trials. Ann Med. 2017 Nov;49(7):552-561. doi: 10.1080/07853890.2017.1306653. Epub 2017 Mar 31.
Results Reference
derived
PubMed Identifier
27940956
Citation
Chen WR, Chen YD, Tian F, Yang N, Cheng LQ, Hu SY, Wang J, Yang JJ, Wang SF, Gu XF. Effects of Liraglutide on Reperfusion Injury in Patients With ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Imaging. 2016 Dec;9(12):e005146. doi: 10.1161/CIRCIMAGING.116.005146.
Results Reference
derived

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Efficacy Study of Glucagonlike Peptide-1 to Treat Reperfusion Injury

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