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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2023

Interventions

  • Drug: Glycoprotein IIb/IIIa inhibitors
    • Glycoprotein IIb/IIIa inhibitors intravenous bolus followed by an intravenous infusion for 12/18 h plus medical standard therapy

Arms, Groups and Cohorts

  • Active Comparator: Glycoprotein IIb/IIIa inhibitor
    • Glycoprotein IIb/IIIa inhibitor administration
  • No Intervention: Standard therapy
    • No glycoprotein IIb/IIIa inhibitors

Clinical Trial Outcome Measures

Primary Measures

  • Infarct size assessed by cardiac magnetic resonance imaging
    • Time Frame: Day 1-10 after myocardial infarction

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Luebeck
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. med. Ingo Eitel, Director, Department of Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck – University of Luebeck

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