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

• Status: Completed
• Trial end date: 2021-02-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: Norwegian University of Science and Technology; South-Eastern Norway Regional Health Authority; St. Olavs Hospital; University of Oslo

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

• Treatment with immunosuppressants other than low dose corticosteroids (equivalent to 5 mg of prednisone or less) at the time of randomisation

• Immunization with a live/attenuated vaccine within 4 weeks prior to baseline

• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or to tocilizumab

• Other contraindications to study medication

• Pregnancy, possible pregnancy or breast-feeding - women of child-bearing potential or breastfeeding mothers cannot participate. A woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

• Contraindications to CMR (pacemaker, CRT, ICD, certain ferromagnetic implants, severe claustrophobia, allergy to contrast medium).

• Any condition/circumstances believed to interfere with the ability to comply with protocol.

• Any reason why, in the opinion of the investigator, the patient should not participate.

• Failure to obtain written, informed consent by patient or next of kin, for instance in case of patient death after consent has been provided in oral.