Effects of Glucagon Like Peptide-1 on No-reflow

Acute ST-segment Elevation Myocardial Infarction Clinical Trial

Official title:

Effects of Glucagon Like Peptide-1 on No-reflow in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02507128
• Other study ID #: 301xnk
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2015
• Last updated: July 22, 2015
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2015
• Source: Chinese PLA General Hospital
• Contact: wei ren chen, M.D.
• Phone: +8601066876221
• Email: chen_weiren[@]sina.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

The investigators planned to evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute ST-segment Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• liraglutide
Liraglutide were taken 30 min before PCI.
• placebo
Placebo were taken 30 min before PCI.

Locations

Country	Name	City	State
China	PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chen Wei Ren, MD

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. Review. — View Citation

Muller O, Trana C, Eeckhout E. Myocardial no-reflow treatment. Curr Vasc Pharmacol. 2013 Mar 1;11(2):278-85. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	differences in the incidences of treatment-emergent adverse events	Treatment-emergent adverse events (TEAEs): hypoglycaemia, pancreatitis, thyroid cancer	immediately after PCI, at 1,3,5 days after PCI	Yes
Primary	a change in the prevalence of no-reflow	The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure.	immediately after PCI	No
Secondary	a change in troponin T	Secondary efficacy variable was troponin T level.	immediately after PCI, at 1,3,5 days after PCI	No
Secondary	a change in high-sensitivity C-reactive protein (hsCRP)	Secondary efficacy variable was high-sensitivity C-reactive protein level.	immediately after PCI, at 1,3,5 days after PCI	No
Secondary	a change in superoxide dismutase (SOD)	Secondary efficacy variable was superoxide dismutase level.	immediately after PCI, at 1,3,5 days after PCI	No