Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Sub-study 1 and 2 were terminated prior to data collection from subjects. However, there is an ongoing extension trial where patients are receiving open-drug label.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
