ASSessing the Effect of Anti-IL-6 Treatment in Myocardial Infarction: The ASSAIL-MI Trial

Summary

The main goal of this study is to evaluate the ability of a single administration of tocilizumab to reduce myocardial damage in patients presenting with an acute ST-segment elevation myocardial infarction (STEMI). Secondary objectives are to assess the impact of treatment on: (i) final infarct size, (ii) left ventricular size and function, (iii) inflammation, (iv) extracellular matrix remodeling, (v) lipid parameters, (vi) platelet activation and additional pro- and anti-thrombotic parameters, and (vii) study drug safety and tolerability.

Conditions

• Coronary Disease
• Myocardial Infarction

Interventions

DRUG

Tocilizumab

Active drug: Tocilizumab, 20 mg/ml; 14 ml (280 mg) dissolved in 100 ml NaCl 0.9 % i.v. once.

DRUG

Sodium chloride 0.9%

Placebo: Sodium chloride 0.9%; 100 ml i.v. once.

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• South-Eastern Norway Regional Health Authority

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• Norwegian University of Science and Technology

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Lars Gullestad, Professor, MD, PhD · Oslo University Hospital

• Bjørn Bendz, Associate Professor, MD, PhD · Oslo University Hospital

• Pål Aukrust, Professor, MD, PhD · Oslo University Hospital

• Svend Aakhus, Professor, MD, PhD · Oslo University Hospital

• Rune Wiseth, Professor, MD, PhD · St. Olavs Hospital

• Jan Kristian Damaas, Professor, MD, PhD · St. Olavs Hospital

• Geir Øystein Andersen, MD, PhD · Oslo University Hospital, Ullevål

• Nils Einar Kløw, Professor, MD, PhD · Oslo University Hospital, Ullevål

• Anders Opdahl, MD, PhD · Oslo University Hospital, Ullevål

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-16

Primary Completion

2020-02-19

Completion

2021-02-10

Countries

• Norway

Study Locations