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

NCT02739711 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: AZ 15-259
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Infarct size assessed by cardiac magnetic resonance imaging

  Day 1-10 after myocardial infarction

Study Arms (2)

Glycoprotein IIb/IIIa inhibitor

ACTIVE COMPARATOR

Glycoprotein IIb/IIIa inhibitor administration

Drug: Glycoprotein IIb/IIIa inhibitors

Standard therapy

NO INTERVENTION

No glycoprotein IIb/IIIa inhibitors

Interventions

Glycoprotein IIb/IIIa inhibitors DRUG

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

Glycoprotein IIb/IIIa inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

University of Luebeck

Lübeck, 23538, Germany

Location

Related Publications (1)

• Eitel I, Saraei R, Jurczyk D, Fach A, Hambrecht R, Wienbergen H, Frerker C, Schmidt T, Allali A, Joost A, Marquetand C, Kurz T, Haaf P, Fahrni G, Mueller C, Desch S, Thiele H, Stiermaier T. Glycoprotein IIb/IIIa inhibitors in acute myocardial infarction and angiographic microvascular obstruction: the REVERSE-FLOW trial. Eur Heart J. 2024 Dec 16;45(47):5058-5067. doi: 10.1093/eurheartj/ehae587.

  PMID: 39217605 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 15, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-05

Locations

DE (1)