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Effects of Glucagon Like Peptide-1 on No-reflow

Primary Purpose

Acute ST-segment Elevation Myocardial Infarction

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

About this trial

This is an interventional treatment trial for Acute ST-segment Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with ST-segment elevation myocardial infarction were eligible for the study.

Exclusion Criteria:

Patients were excluded for the following reasons: unconscious at presentation; had cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; had a history of myocardial infarction, stent thrombosis, or renal insufficiency; or had previously undergone coronary artery bypass surgery.

Sites / Locations

  • PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GLP-1 group

Control group

Arm Description

The treatment started 30 min before PCI with a dose of 1.8 mg liraglutide (the treatment was administered in the ambulance).

the treatment started 30 min before PCI with a dose of 1.8 mg placebo (the treatment was administered in the ambulance).

Outcomes

Primary Outcome Measures

a change in the prevalence of no-reflow
The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure.

Secondary Outcome Measures

a change in troponin T
Secondary efficacy variable was troponin T level.
a change in high-sensitivity C-reactive protein (hsCRP)
Secondary efficacy variable was high-sensitivity C-reactive protein level.
a change in superoxide dismutase (SOD)
Secondary efficacy variable was superoxide dismutase level.

Full Information

First Posted
July 22, 2015
Last Updated
July 22, 2015
Sponsor
Chen Wei Ren, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02507128
Brief Title
Effects of Glucagon Like Peptide-1 on No-reflow
Official Title
Effects of Glucagon Like Peptide-1 on No-reflow in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 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 evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI).
Detailed Description
Acute myocardial infarction (AMI) is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (PCI) is currently the most effective treatment strategy for AMI. Brisk thrombolysis in myocardial infarction (TIMI) grade 3 flow immediately after PCI in patients with AMI is associated with improved clinical outcomes compared with lower flow grades. However, myocardial reperfusion is suboptimal in many patients, mostly because of the 'no-reflow' phenomenon. No-reflow is defined as suboptimal myocardial reperfusion in part of the coronary circulation without angiographic evidence of mechanical vessel obstruction. To date, however, very few drugs have been shown to reverse established no-reflow. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction. GLP-1 has antioxidant and anti-inflammatory properties, and may protect endothelial function. Experimental studies have also revealed that GLP-1 or its analogues protect against reperfusion injury in pigs. Exenatide, a GLP-1 analogue, was reported to reduce reperfusion injury in patients with ST-segment elevation myocardial infarction. Similarly, liraglutide was reported to reduce cardiac rupture and infarct size and improve cardiac output in normal and diabetic mice. To date, however, there is no clinical evidence for the effects of liraglutide on no-reflow in patients with AMI. Therefore, the aim of this study was to evaluate the effects of liraglutide pretreatment on myocardial no-reflow of prime PCI in patients with AMI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST-segment Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GLP-1 group
Arm Type
Experimental
Arm Description
The treatment started 30 min before PCI with a dose of 1.8 mg liraglutide (the treatment was administered in the ambulance).
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
the treatment started 30 min before PCI with a dose of 1.8 mg placebo (the treatment was administered in the ambulance).
Intervention Type
Drug
Intervention Name(s)
liraglutide
Other Intervention Name(s)
glucagon like peptide-1
Intervention Description
Liraglutide were taken 30 min before PCI.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo were taken 30 min before PCI.
Primary Outcome Measure Information:
Title
a change in the prevalence of no-reflow
Description
The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure.
Time Frame
immediately after PCI
Secondary Outcome Measure Information:
Title
a change in troponin T
Description
Secondary efficacy variable was troponin T level.
Time Frame
immediately after PCI, at 1,3,5 days after PCI
Title
a change in high-sensitivity C-reactive protein (hsCRP)
Description
Secondary efficacy variable was high-sensitivity C-reactive protein level.
Time Frame
immediately after PCI, at 1,3,5 days after PCI
Title
a change in superoxide dismutase (SOD)
Description
Secondary efficacy variable was superoxide dismutase level.
Time Frame
immediately after PCI, at 1,3,5 days after PCI
Other Pre-specified Outcome Measures:
Title
differences in the incidences of treatment-emergent adverse events
Description
Treatment-emergent adverse events (TEAEs): hypoglycaemia, pancreatitis, thyroid cancer
Time Frame
immediately after PCI, at 1,3,5 days after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ST-segment elevation myocardial infarction were eligible for the study. Exclusion Criteria: Patients were excluded for the following reasons: unconscious at presentation; had cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; had a history of myocardial infarction, stent thrombosis, or renal insufficiency; or had previously undergone coronary artery bypass surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wei ren chen, M.D.
Phone
+8601066876221
Email
chen_weiren@sina.com
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
12517460
Citation
Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.
Results Reference
background
PubMed Identifier
11997276
Citation
Gibson CM, Cannon CP, Murphy SA, Marble SJ, Barron HV, Braunwald E; TIMI Study Group. Relationship of the TIMI myocardial perfusion grades, flow grades, frame count, and percutaneous coronary intervention to long-term outcomes after thrombolytic administration in acute myocardial infarction. Circulation. 2002 Apr 23;105(16):1909-13. doi: 10.1161/01.cir.0000014683.52177.b5.
Results Reference
background
PubMed Identifier
19021281
Citation
Rezkalla SH, Kloner RA. Coronary no-reflow phenomenon: from the experimental laboratory to the cardiac catheterization laboratory. Catheter Cardiovasc Interv. 2008 Dec 1;72(7):950-7. doi: 10.1002/ccd.21715.
Results Reference
background
PubMed Identifier
23506504
Citation
Muller O, Trana C, Eeckhout E. Myocardial no-reflow treatment. Curr Vasc Pharmacol. 2013 Mar 1;11(2):278-85.
Results Reference
background
PubMed Identifier
19195607
Citation
Timmers L, Henriques JP, de Kleijn DP, Devries JH, Kemperman H, Steendijk P, Verlaan CW, Kerver M, Piek JJ, Doevendans PA, Pasterkamp G, Hoefer IE. Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury. J Am Coll Cardiol. 2009 Feb 10;53(6):501-10. doi: 10.1016/j.jacc.2008.10.033.
Results Reference
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Effects of Glucagon Like Peptide-1 on No-reflow

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