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NCT03004703: ASSAIL-MI

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

Completed Phase 2 Last updated 2 March 2021
What this trial tests

Phase 2 trial testing Tocilizumab in Coronary Disease in 200 participants. Completed in 10 February 2021.

Timeline
16 March 2017
Primary endpoint
19 February 2020
10 February 2021

Quick facts

Lead sponsorOslo University Hospital
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment200
Start date16 March 2017
Primary completion19 February 2020
Estimated completion10 February 2021
Sites3 locations across Norway

Drugs / interventions tested

Conditions studied

Sponsor

Oslo University Hospital

Who can join

Adults 18 to 80, any sex, with Coronary Disease or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting inflammation in atherosclerosis - from experimental insights to the clinic.
    Soehnlein O, Libby P. · · 2021 · cited 723× · PMID 33976384 · DOI 10.1038/s41573-021-00198-1
  2. Inflammation following acute myocardial infarction: Multiple players, dynamic roles, and novel therapeutic opportunities.
    Ong SB, Hernández-Reséndiz S, Crespo-Avilan GE, Mukhametshina RT, et al · · 2018 · cited 640× · PMID 29330085 · DOI 10.1016/j.pharmthera.2018.01.001
  3. Randomized Trial of Interleukin-6 Receptor Inhibition in Patients With Acute ST-Segment Elevation Myocardial Infarction.
    Broch K, Anstensrud AK, Woxholt S, Sharma K, et al · · 2021 · cited 330× · PMID 33858620 · DOI 10.1016/j.jacc.2021.02.049
  4. Anticytokine Agents: Targeting Interleukin Signaling Pathways for the Treatment of Atherothrombosis
    Ridker PM. · · 2019 · cited 205× · PMID 30702995 · DOI 10.1161/circresaha.118.313129
  5. Macrophages in cardiovascular diseases: molecular mechanisms and therapeutic targets.
    Chen R, Zhang H, Tang B, Luo Y, et al · · 2024 · cited 169× · PMID 38816371 · DOI 10.1038/s41392-024-01840-1
  6. The Two-Faced Cytokine IL-6 in Host Defense and Diseases.
    Narazaki M, Kishimoto T. · · 2018 · cited 139× · PMID 30423923 · DOI 10.3390/ijms19113528
  7. Meta-analysis investigating the role of interleukin-6 mediated inflammation in type 2 diabetes.
    Bowker N, Shah RL, Sharp SJ, Luan J, et al · · 2020 · cited 86× · PMID 33096487 · DOI 10.1016/j.ebiom.2020.103062
  8. Association of Interleukin 6 Receptor Variant With Cardiovascular Disease Effects of Interleukin 6 Receptor Blocking Therapy: A Phenome-Wide Association Study.
    Cai T, Zhang Y, Ho YL, Link N, et al · · 2018 · cited 84× · PMID 30090940 · DOI 10.1001/jamacardio.2018.2287

Verify or expand the search:

Other trials of Tocilizumab

Trials testing the same drug.

Other recruiting trials for Coronary Disease

Currently open trials in the same condition.

Other Oslo University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03004703.

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