Myocardial Protection of Exenatide in AMI

NCT01580514 | Completed Phase 4 DMC

• 1 other identifier: KHMC-2012001
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

Experimental evidence suggests exenatide, a glucagon-like peptide 1 receptor analogue, has significant cardiovascular protective effects in various conditions. The investigators examined whether conventional use of exenatide at the time of primary percutaneous coronary intervention would reduce the infarct size in patients with ST-segment elevation myocardial infarction (STEMI).

Conditions

Myocardial Infarction

Keywords

myocardial infarction; percutaneous coronary intervention; exenatide; reperfusion injury; cardiac magnetic resonance

Outcome Measures

Primary Outcomes (1)

• Infarct size

  Infarct size was assessed by measuring the release of creatine kinase-MB and troponin I during 72 hours and by performing cardiac magnetic resonance imaging on 1 month after infarction.

  1 month

Secondary Outcomes (3)

• Number of Participants with Adverse Events

  6 month after primary PCI

• LV function

  at admission and 6 month after primary PCI

• Clinical outcomes

  6 months after primary PCI

Study Arms (2)

Exenatide

ACTIVE COMPARATOR

Drug: Exenatide 10 μg subcutaneous and 10 μg intravenously injection of exenatide BYETTA® (Amylin-Lilly) 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.

Drug: exenatide BYETTA® (Amylin-Lilly)

Saline

PLACEBO COMPARATOR

Drug: Saline 10 μg subcutaneous and 10 μg intravenously injection of equivalent volume of normal saline 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.

Drug: Saline

Interventions

exenatide BYETTA® (Amylin-Lilly) DRUG

After informed consent was obtained, patients who met the enrollment criteria were randomly assigned to either the control group or the exenatide group. Patients assigned to exenatide were treated with 10 μg subcutaneous and 10 μg intravenously injection of exenatide BYETTA® (Amylin-Lilly) 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.

Also known as: Saline

Exenatide

Saline DRUG

After informed consent was obtained, patients who met the enrollment criteria were randomly assigned to either the control group or the exenatide group. Patients assigned to saline were treated with 10 μg subcutaneous and 10 μg intravenously injection of equivalent volume of normal saline 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.

Also known as: Exenatide

Saline

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 20 and 79 years
• patients presenting with first ST-segment elevation myocardial infarction
• Thrombolysis in Myocardial Infarction \[TIMI\] flow grade 0)

You may not qualify if:

• cardiac arrest
• ventricular fibrillation
• cardiogenic shock
• hemodynamic instability
• suspicious stent thrombosis
• left bundle branch block
• previous acute myocardial infarction
• previous coronary artery bypass operation
• significant valvular heart disease
• primary myocardial disease
• atrial fibrillation
• significant hepatic or renal dysfunction, hypoglycaemia,
• diabetic ketoacidosis
• active infection or chronic inflammatory disease
• malignancy

Sponsors & Collaborators

• Kyunghee University Medical Center: lead

Study Sites (1)

Kyung Hee University Hospital

Seoul, Seoul, 130-872, South Korea

Location

Related Publications (3)

• 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.

  PMID: 19195607 BACKGROUND

• 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.

  PMID: 28286967 DERIVED

• Woo JS, Kim W, Ha SJ, Kim JB, Kim SJ, Kim WS, Seon HJ, Kim KS. Cardioprotective effects of exenatide in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of exenatide myocardial protection in revascularization study. Arterioscler Thromb Vasc Biol. 2013 Sep;33(9):2252-60. doi: 10.1161/ATVBAHA.113.301586. Epub 2013 Jul 18.

  PMID: 23868944 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Reperfusion Injury

Interventions

Sodium Chloride; Exenatide

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Postoperative Complications

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Weon Kim, MD, PhD

  Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 19, 2012
• Study Start: September 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

KR (1)