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

NCT03004703 | Completed Phase 2 DMC

• 2 other identifiers: ASSAIL-MI 2.02016-002581-31
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Interleukin 6; Tocilizumab; Acute coronary syndrome; STEMI; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Secondary Outcomes (7)

• The between-group difference in the AUC for Troponin T (TnT) during index hospitalisation

  24 -72 hours after randomisation

• The extent of microvascular obstruction as measured by CMR after 3 - 7 days

  3 - 7 days after randomisation

• Final infarct size as measured by CMR 6 months after randomisation

  6 months after randomisation

• Left ventricular size as assessed by CMR 6 months after randomisation

  6 months after randomisation

• Baseline-adjusted NT-proBNP at 6 months after randomisation

  6 months after randomisation

Study Arms (2)

Active drug

EXPERIMENTAL

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

Drug: Tocilizumab

Placebo

PLACEBO COMPARATOR

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

Drug: Sodium chloride 0.9%

Interventions

Tocilizumab DRUG

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

Also known as: RoActemra®,

Active drug

Sodium chloride 0.9% DRUG

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

Also known as: NaCl 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be screened for eligibility upon admittance due to acute STEMI at either participating site. All of the following conditions must apply to the prospective patient at screening prior to receiving study agent:
• New ST elevation at the J-point in two contiguous leads (cut-points: 0.2mV in men and \>0.15 mV in women in leads V2-V3 and/or \>0.1 mV in other leads) in combination with symptoms consistent with acute MI.
• Presentation within 6 hours of chest pain.
• Indication for urgent coronary angiography with intent to reperfuse presumed occluded vessel.
• Age between 18 and 80 years.
• Informed consent obtained and documented according to ICH/GCP, and national/local regulations.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following criteria:
• NSTEMI (non-ST segment elevation in ECG).
• Left bundle branch block in ECG
• History of previous MI
• Cardiogenic shock.
• Fibrinolytic therapy within 72 hours prior to admission.
• Cardiac arrest / ventricular fibrillation.
• History of severe renal failure with estimated glomerular filtration rate \< 30 ml/minutes.
• Known, current liver disease
• History of concurrent inflammatory, biliary obstructive or malignant disease
• A history of chronic or concurrent infectious disease, including a history of HIV, tuberculosis, or hepatitis B or C.
• Known, uncontrolled lower gastrointestinal (GI) disease such as diverticulitis, Crohn's disease, ulcerative colitis, or other symptomatic lower GI conditions that could predispose to GI perforations
• Major surgery within 8 weeks prior or after baseline
• History of central nervous system demyelinating or seizure disorders
• History of primary or secondary immunodeficiency

Sponsors & Collaborators

• Oslo University Hospital: lead
• St. Olavs Hospital: collaborator
• South-Eastern Norway Regional Health Authority: collaborator
• University of Oslo: collaborator
• Norwegian University of Science and Technology: collaborator

Study Sites (3)

Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

Location

Oslo University Hospital, Ullevål

Oslo, 0424, Norway

Location

St. Olav Hospital

Trondheim, 7006, Norway

Location

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MeSH Terms

Conditions

Coronary Disease; Myocardial Infarction; Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Inflammation

Interventions

tocilizumab; Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lars Gullestad, Professor, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Bjørn Bendz, Associate Professor, MD, PhD

  Oslo University Hospital

  STUDY CHAIR

• Pål Aukrust, Professor, MD, PhD

  Oslo University Hospital

  STUDY CHAIR

• Svend Aakhus, Professor, MD, PhD

  Oslo University Hospital

  STUDY CHAIR

• Rune Wiseth, Professor, MD, PhD

  St. Olavs Hospital

  STUDY CHAIR

• Jan Kristian Damaas, Professor, MD, PhD

  St. Olavs Hospital

  STUDY CHAIR

• Geir Øystein Andersen, MD, PhD

  Oslo University Hospital, Ullevål

  STUDY CHAIR

• Nils Einar Kløw, Professor, MD, PhD

  Oslo University Hospital, Ullevål

  STUDY CHAIR

• Anders Opdahl, MD, PhD

  Oslo University Hospital, Ullevål

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 29, 2016
• Study Start: March 16, 2017
• Primary Completion: February 19, 2020
• Study Completion: February 10, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-02

Locations

NO (3)