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

May 23, 2023 updated by: Prof. Dr. med. Ingo Eitel, University of Luebeck

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Luebeck, Germany, 23538
        • Recruiting
        • University of Luebeck
        • Contact:
        • Principal Investigator:
          • Ingo Eitel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimated)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ 15-259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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