Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events) "CANTOS"

Active, not recruiting

Phase 3 Results N/A

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. Other protocol-defined inclusion/exclusion criteria may apply