CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 200 enrolled
Drug / intervention
Tocilizumab +1 moredrug
Likely dose
Tocilizumab 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03004703
NCT03004703Phase 2Completed

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

Oslo University Hospital·interventional·Posted Dec 29, 2016·Updated Mar 2, 2021

In Brief

A Phase 2 clinical trial evaluating Tocilizumab and Sodium chloride 0.9% for Coronary Disease and Myocardial Infarction. Completed, enrolled 200 participants across 3 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 29, 2016
Enrollment StartMar 16, 2017
Primary CompletionFeb 19, 2020
Study CompletionFeb 10, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.5 years ago

Interventions

Tocilizumabdrug

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.