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

University of Luebeck

Status and phase: Active, not recruiting; Phase 4

Conditions: Acute Myocardial Infarction

Treatments: Drug: Glycoprotein IIb/IIIa inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT02739711

AZ 15-259

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Glycoprotein IIb/IIIa inhibitor

Active Comparator group

Description:

Glycoprotein IIb/IIIa inhibitor administration

Treatment:

Drug: Glycoprotein IIb/IIIa inhibitors

Standard therapy

No Intervention group

Description:

No glycoprotein IIb/IIIa inhibitors