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NCT02739711 Clinical Trial

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

Acute Myocardial Infarction Clinical Trial

— REVERSE-FLOW  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02739711
Other study ID # AZ 15-259
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 2016
Est. completion date December 2025

Study information
Verified date May 2024
Source University of Luebeck
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 2025
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany University of Luebeck Luebeck

Sponsors (1)
Lead Sponsor Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Infarct size assessed by cardiac magnetic resonance imaging Day 1-10 after myocardial infarction
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