NCT02507128

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

July 22, 2015

Last Update Submit

July 22, 2015

Conditions

Acute ST-segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • a change in troponin T

    immediately after PCI, at 1,3,5 days after PCI

  • a change in high-sensitivity C-reactive protein (hsCRP)

    immediately after PCI, at 1,3,5 days after PCI

  • a change in superoxide dismutase (SOD)

    immediately after PCI, at 1,3,5 days after PCI

Other Outcomes (1)

  • differences in the incidences of treatment-emergent adverse events

    immediately after PCI, at 1,3,5 days after PCI

Study Arms (2)

GLP-1 group

EXPERIMENTAL

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

Drug: liraglutide

Control group

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

liraglutideDRUG

Liraglutide were taken 30 min before PCI.

Also known as: glucagon like peptide-1
GLP-1 group
placeboDRUG

Placebo were taken 30 min before PCI.

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 12517460BACKGROUND

  • 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.

    PMID: 11997276BACKGROUND

  • 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.

    PMID: 19021281BACKGROUND

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

    PMID: 23506504BACKGROUND

  • 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: 19195607BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

LiraglutideGlucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

wei ren chen, M.D.

CONTACT

+8601066876221chen_weiren@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 23, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

CN(1)