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

Primary Purpose

Acute Myocardial Infarction

Status
Recruiting
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Glycoprotein IIb/IIIa inhibitors
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of LuebeckRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Glycoprotein IIb/IIIa inhibitor

Standard therapy

Arm Description

Glycoprotein IIb/IIIa inhibitor administration

No glycoprotein IIb/IIIa inhibitors

Outcomes

Primary Outcome Measures

Infarct size assessed by cardiac magnetic resonance imaging

Secondary Outcome Measures

Full Information

First Posted
April 13, 2016
Last Updated
May 23, 2023
Sponsor
University of Luebeck
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1. Study Identification

Unique Protocol Identification Number
NCT02739711
Brief Title
Glycoprotein IIb/IIIa Inhibitors Versus Standard Therapy in Patients With Myocardial Infarction and No-reflow
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glycoprotein IIb/IIIa inhibitor
Arm Type
Active Comparator
Arm Description
Glycoprotein IIb/IIIa inhibitor administration
Arm Title
Standard therapy
Arm Type
No Intervention
Arm Description
No glycoprotein IIb/IIIa inhibitors
Intervention Type
Drug
Intervention Name(s)
Glycoprotein IIb/IIIa inhibitors
Intervention Description
Glycoprotein IIb/IIIa inhibitors intravenous bolus followed by an intravenous infusion for 12/18 h plus medical standard therapy
Primary Outcome Measure Information:
Title
Infarct size assessed by cardiac magnetic resonance imaging
Time Frame
Day 1-10 after myocardial infarction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingo Eitel
Email
ingo.eitel@uksh.de
First Name & Middle Initial & Last Name & Degree
Ingo Eitel

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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