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

Sponsor
Oslo University Hospital
Study ID
NCT03004703
Phase
PHASE2
Status
Completed

Conditions

  • Coronary Disease
  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 16, 2017
Status verified
Feb 2021
Primary completion
Feb 19, 2020
Completion
Feb 10, 2021

Study Design

Enrollment
200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

The primary endpoint will be the between-group difference in the myocardial salvage index as measured in the acute phase by cardiac magnetic resonance (CMR) imaging with late gadolinium enhancement (LGE). [ Time Frame: 6 months ]

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