Exenatide for Myocardial Protection During Reperfusion Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to assess the effect of exenatide on myocardial injury in patients undergoing emergent percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction or heart attack (STEMI).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Additional Treatment With EXenatide in Patients With an Acute Myocardial Infarction (the EXAMI Trial)

NCT01254123

Patients With a First Acute Myocardial Infarction to be Treated With Primary Percutaneous Coronary Intervention (PCI).

UNKNOWN PHASE3

Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

NCT01372930

Myocardial Infarction

UNKNOWN PHASE4

A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.

NCT03998319

STEMI Elevated IMR (>32)

RECRUITING PHASE3

A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI)

NCT01347580

Myocardial Infarction Segment Elevation Myocardial Infarction (STEMI)

COMPLETED PHASE4

Myocardial Injury After Elective Coronary Stenting

NCT01986621

Coronary Artery Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a Phase II randomized, double-blind, placebo-controlled study of patients with STEMI. Those who agree to participate will be immediately randomized to one of two groups: a 24-h infusion of exenatide; or a 24 h infusion of placebo. We will assess the ability of exenatide to reduce ischemic injury. This study will serve as safety evaluation study as well as a pilot for a larger multicentre trial powered for clinical outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exenatide

o Exenatide at a dose of 1.5 µg IV over 30 min followed by 1.2 µg/hr IV for 1.5 h (Rate1), followed by 1.9 µg/hr IV\* for 22 h (Rate 2)

\*Once the creatinine clearance is available, if the value is \<60 mL/min, the rate at 2 hours will be maintained at Rate 1 for the duration of the infusion. If the value becomes available after the 2-hour point, and the rate has already been changed to Rate 2, the infusion will be titrated back down to Rate 1 if the creatinine clearance is \<60 mL/min.

If the creatinine clearance is \<30 mL/min, the infusion will be discontinued and the patient will otherwise continue with all study procedures.

A bolus administration of study medication is initiated preferably prior to reperfusion, or, if not possible, up to 30 minutes after the start of reperfusion to avoid delays in door-to-door balloon times.

Group Type EXPERIMENTAL

Exenatide

Intervention Type DRUG

Intravenous bolus and 24-hour infusion of exenatide

Placebo

o Placebo bolus over 30 min followed by placebo infusion at 'Rate 1' for 1.5 h, followed by 'Rate 2' for 22 hours\*.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous bolus and 24-hour infusion of placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exenatide

Intravenous bolus and 24-hour infusion of exenatide

Intervention Type DRUG

Placebo

Intravenous bolus and 24-hour infusion of placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Byetta

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Admission for primary PCI for STEMI, with enrollment within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥1mm in 2 or more limb leads, or ≥2mm in 2 or more precordial leads, or new onset LBBB) associated with acute chest pain or an elevation of cardiac enzymes.
* Antegrade TIMI 0 or 1 prior to PCI in the infarct-related artery
* Age ≥18 years

Exclusion Criteria

* Symptomatic hypoglycemia (serum glucose \<3.3 µmol/L; 60 mg/dl)
* Diabetes mellitus requiring insulin therapy
* Diabetic ketoacidosis
* Coronary anatomy warranting emergent coronary artery bypass graft surgery
* Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation)
* Need for hemodialysis
* Malignancy, HIV, or central nervous system disorder
* Cardiopulmonary resuscitation \>15 min and compromised level of consciousness.
* Cardiogenic shock
* Current participation in any research study involving investigational drugs or devices
* Inability to give informed consent
* Inability to safely undergo cMRI (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant, severe claustrophobia)
* Women of childbearing potential who are known to be pregnant or lactating or who have a positive pregnancy test on admission
* History of pancreatitis
* Known end stage renal failure or known eGFR \<30 mL/min
* Currently taking exenatide (Byetta, Bydureon), liraglutide (Victoza), or any other GLP-1 agonist

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No