Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events) (CANTOS)
Atherosclerosis
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring Cardiovascular Death, Myocardial Infarction, Stroke, Canakinumab, IL-1B, hsCRP
Eligibility Criteria
Main Study Inclusion Criteria:
- Written informed consent
- Male, or Female of non-child-bearing potential
- Age ≥ 18 years.
- Spontaneous MI at least 30 days before randomization. hsCRP ≥ 2 mg/L
Substudy 1 Inclusion:
- All Inclusion from Main Study
- Acquisition of evaluable baseline MRI images of bilateral carotid arteries by the imaging core laboratory
Substudy 2 Inclusion:
- All inclusion from Main Study
- T2D at baseline per Main protocol criteria and be on a stable anti-hyperglycemic medication for at least 4 weeks prior to the baseline OGTT test
- Willing to have the OGTT assessment started before 10 am
Main Study Exclusion Criteria:
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Any of the following concomitant diseases
- Planned coronary revascularization (PCI or CABG)
- Major non-cardiac surgical or endoscopic procedure within past 6 months
- Multi-vessel CABG surgery within the past 3 years
- Symptomatic patients with Class IV heart failure (HF) (New York Heart Association [NYHA].
- Uncontrolled hypertension
- Uncontrolled diabetes
- History or evidence of active tuberculosis (TB) infection Substudy 1 Exclusion
- All Main exclusion
- Patients with prior history of carotid angioplasty, stenting, or carotid atherectomy
- Patients with contraindications to MRI examination (brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body or other implanted body, tattoos, implanted insulin pump, metal shrapnel or bullet)
- Patients prone to claustrophobia or known anxiety disorders
- BMI > 40 kg/m2 Substudy 2 Exclusion
- This sub-study does not have any additional exclusion criteria.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Canakinumab Dose 50 mg
Canakinumab Dose 150 mg
Canakinumab Dose 300 mg
Placebo
Pivotal Phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care therapy. Extension Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy
Pivotal Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy
Pivotal Phase: Blinded Canakinumab 300 mg quarterly subcutaneous (with one additional dose at week 2) + standard of care therapy. Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy
Pivotal Phase: Blinded matching placebo quarterly subcutaneous + standard of care therapy. Extension Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy