Myocardial Protection of Exenatide in AMI

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-08-31

Brief Summary

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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).

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Detailed Description

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In this proof-of-concept trial, we assessed the effects of acute-phase adjunctive exenatide therapy in patients with STEMI.

Infarct size after STEMI was evaluated by both cardiac magnetic resonance image and cardiac biomarkers compared with standard treatment.

LV function was assessed by conventional and speckle tracking echocardiography. During 6-month follow up, the safety/tolerability of exenatide and clinical outcomes were also assessed.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Exenatide

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.

Group Type ACTIVE_COMPARATOR

exenatide BYETTA® (Amylin-Lilly)

Intervention Type 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.

Saline

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.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type 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.

Interventions

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exenatide BYETTA® (Amylin-Lilly)

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.

Intervention Type DRUG

Saline

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.

Intervention Type DRUG

Other Intervention Names

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Saline Exenatide

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
* women who were pregnant or who were of childbearing age

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No