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

NCT ID: NCT02739711

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glycoprotein IIb/IIIa inhibitor

Glycoprotein IIb/IIIa inhibitor administration

Group Type ACTIVE_COMPARATOR

Glycoprotein IIb/IIIa inhibitors

Intervention Type DRUG

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

Standard therapy

No glycoprotein IIb/IIIa inhibitors

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Glycoprotein IIb/IIIa inhibitors

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Ingo Eitel

Director, Department of Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Luebeck

Lübeck, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 39217605 (View on PubMed)

Other Identifiers

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AZ 15-259

Identifier Type: -

Identifier Source: org_study_id

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