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
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

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