GLP-1 on Non-ST-Segment Elevation Myocardial Infarction
Effects of Liraglutide on Left Ventricular Function in Patients With Non-ST-Segment Elevation Myocardial Infarction
1 other identifier
interventional
90
1 country
1
Brief Summary
The investigators planned to evaluate the effects of liraglutide on left ventricular function in patients with non-ST-segment elevation myocardial infarction (NSTEMI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 15, 2015
CompletedFirst Posted
Study publicly available on registry
October 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 19, 2015
October 1, 2015
1 year
October 15, 2015
October 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
left ventricular ejection fractions
The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by transthoracic echocardiography at 3 months .
at 3 months
Secondary Outcomes (2)
6-minute walk distance
at 3 months
treatment-emergent adverse events
at 3 months
Study Arms (2)
GLP-1 group
EXPERIMENTALliraglutide (Novo Nordisk, Bagsværd, Denmark); the frequency: Subcutaneous liraglutide were taken daily; duration: 7 days. After admission, the patients were treated with 0.6 mg liraglutide once daily for 2 day, then 1.2 mg liraglutide for another 2 day, and then 1.8 mg liraglutide for 3 days.
placebo
PLACEBO COMPARATORplacebo (Novo Nordisk, Bagsværd, Denmark); the frequency: Placebo were taken daily; duration: After admission, the patients were treated with 0.6 mg placebo once daily for 2 day, then 1.2 mg placebo for another 2 day, and then 1.8 mg placebo for 3 days.
Interventions
Eligibility Criteria
You may qualify if:
- non-ST-segment elevation myocardial infarction (NSTEMI )
You may not qualify if:
- unconscious at presentation
- had ST-segment elevation acute myocardial infarction
- NSTEMI requiring emergency percutaneous coronary angiography
- valvular heart disease
- cardiogenic shock
- hypoglycaemia
- diabetic ketoacidosis
- had a history of myocardial infarction
- stent implantation
- renal insufficiency
- had previously undergone coronary artery bypass surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Related Publications (5)
Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg JM, Miller DL, Costigan TM, Goedicke J, Silvain J, Angioli P, Legutko J, Niethammer M, Motovska Z, Jakubowski JA, Cayla G, Visconti LO, Vicaut E, Widimsky P; ACCOAST Investigators. Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes. N Engl J Med. 2013 Sep 12;369(11):999-1010. doi: 10.1056/NEJMoa1308075. Epub 2013 Sep 1.
PMID: 23991622BACKGROUNDAronson D, Hammerman H, Kapeliovich MR, Suleiman A, Agmon Y, Beyar R, Markiewicz W, Suleiman M. Fasting glucose in acute myocardial infarction: incremental value for long-term mortality and relationship with left ventricular systolic function. Diabetes Care. 2007 Apr;30(4):960-6. doi: 10.2337/dc06-1735.
PMID: 17392556BACKGROUNDLonborg 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.
PMID: 21920963BACKGROUNDCeriello A, Novials A, Ortega E, Canivell S, La Sala L, Pujadas G, Esposito K, Giugliano D, Genovese S. Glucagon-like peptide 1 reduces endothelial dysfunction, inflammation, and oxidative stress induced by both hyperglycemia and hypoglycemia in type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2346-50. doi: 10.2337/dc12-2469. Epub 2013 Apr 5.
PMID: 23564922BACKGROUNDNikolaidis LA, Doverspike A, Hentosz T, Zourelias L, Shen YT, Elahi D, Shannon RP. Glucagon-like peptide-1 limits myocardial stunning following brief coronary occlusion and reperfusion in conscious canines. J Pharmacol Exp Ther. 2005 Jan;312(1):303-8. doi: 10.1124/jpet.104.073890. Epub 2004 Sep 8.
PMID: 15356213BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
zhu Chen
World Health Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
October 15, 2015
First Posted
October 16, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
October 19, 2015
Record last verified: 2015-10