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NCT03004703: ASSAIL-MI
ASSessing the Effect of Anti-IL-6 Treatment in Myocardial Infarction: The ASSAIL-MI Trial
Phase 2 trial testing Tocilizumab in Coronary Disease in 200 participants. Completed in 10 February 2021.
19 February 2020
Quick facts
| Lead sponsor | Oslo University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 16 March 2017 |
| Primary completion | 19 February 2020 |
| Estimated completion | 10 February 2021 |
| Sites | 3 locations across Norway |
Drugs / interventions tested
- Tocilizumab (tocilizumab) — full drug profile →
- Sodium chloride 0.9%
Conditions studied
- Coronary Disease — all drugs for Coronary Disease →
- Myocardial Infarction — all drugs for Myocardial Infarction →
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):
-
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 -
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 -
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 -
Anticytokine Agents: Targeting Interleukin Signaling Pathways for the Treatment of Atherothrombosis
Ridker PM. · · 2019 · cited 205× · PMID 30702995 · DOI 10.1161/circresaha.118.313129 -
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 -
The Two-Faced Cytokine IL-6 in Host Defense and Diseases.
Narazaki M, Kishimoto T. · · 2018 · cited 139× · PMID 30423923 · DOI 10.3390/ijms19113528 -
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 -
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:
- PubMed search for NCT03004703
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03004703 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oslo University Hospital
- Last refreshed: 2 March 2021
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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