Glycoprotein IIb/IIIa Inhibitors Versus Standard Therapy in Patients With Myocardial Infarction and No-reflow

Study Overview
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Brief Summary
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Aim of the study is to examine the effects of glycoprotein IIb/IIIa inhibitors on reperfusion success assessed by cardiac magnetic resonance imaging in patients with myocardial infarction and angiographic evidence of no-reflow.

Official Title
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Prospective RandomizEd Study Comparing Glycoprotein IIb/IIIa Inhibitors VERsus Standard Therapy in patientS With Myocardial Infarction and Angiographic Evidence of No-reFLOW

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Glycoprotein IIb/IIIa inhibitors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ST-elevation myocardial infarction and non-ST-elevation myocardial infarction <48 h after symptom onset Angiographic evidence of no-reflow (Thrombolysis in Myocardial Infarction-flow grade ≤2) after primary percutaneous coronary intervention Age ≥18 years Informed consent Exclusion Criteria: ST-elevation myocardial infarction and non-ST-elevation myocardial infarction patients with Thrombolysis in Myocardial Infarction-flow 3 after primary percutaneous coronary intervention Age ≤18 years Known pregnancy, breast-feeding or intend to become pregnant during the study period Contraindication for treatment with platelet inhibitors Known allergy to glycoprotein IIb/IIIa inhibitors, aspirin, or heparin Active peptic gastric or duodenal ulcer History of major surgery (including intracranial or intraspinal) <4 weeks Active bleeding or bleeding diathesis Stroke <2 years (ischemic and hemorrhagic) Known coagulation defect or relevant thrombocytopenia Arteriovenous malformations or aneurysm Severe liver insufficiency Renal insufficiency requiring dialysis Uncontrolled hypertension Hypertensive retinopathy Vasculitis Fibrinolysis <12 hours Contraindication for cardiac magnetic resonance imaging at study entry Patients without informed consent Participation in another trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glycoprotein IIb/IIIa inhibitor<br>Glycoprotein IIb/IIIa inhibitor administration | Drug: Glycoprotein IIb/IIIa inhibitors<br>* Glycoprotein IIb/IIIa inhibitors intravenous bolus followed by an intravenous infusion for 12/18 h plus medical standard therapy<br>|
| No Intervention: Standard therapy<br>No glycoprotein IIb/IIIa inhibitors | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size assessed by cardiac magnetic resonance imaging |  | Day 1-10 after myocardial infarction |