Phase 3 - interventional, randomized, parallel-group, double blinded, placebocontrolled,
Multi-Centre, Multi-National CVOT on CV outcomes in participants
with established ASCVD, CKD, and systemic inflammation.
Inclusion:
eGFR > 15
Evidence of Atherosclerotic Cardiovascular Disease (ASCVD)
o Coronary Heart Disease
History of MI
Coronary revascularization, cardiac catherization, or CT Coronary
Angiography
o Cerebrovascular Disease
History of Stroke
Symptomatic Peripheral Artery Disease (PAD)
Exclusion:
Diagnosis of Human Immunodeficiency Virus (HIV).
On chronic or intermittent hemodialysis or peritoneal dialysis.
History of bone marrow or solid organ transplant or anticipated organ transplant
during the study.
Use preventative systemic antibiotics, systemic antivirals, or systemic antifungals
Use of systemic immunosuppressive drugs (both small molecules and biologics).
This is not a complete list of inclusion and exclusion criteria for this study.