Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease

"Cardiovascular Polypill contains Valsartan, Atorvastatin, Aspirin~1. Valsartan 160 mg + Atorvastatin 40 mg + Aspirin 100 mg~ or~2. Valsartan 160 mg + Atorvastatin 80 mg + Aspirin 100 mg~ or~3. Valsartan 320 mg + Atorvastatin 40 mg + Aspirin 100 mg~ or~4. Valsartan 320 mg + Atorvastatin 80 mg + Aspirin100 mg~ or~5. Valsartan 160 mg + Atorvastatin 20 mg + Aspirin 100 mg\*~ or~6. Valsartan 320 mg + Atorvastatin 20 mg + Aspirin 100 mg\*~ * The use of these formulations of the cardiovascular polypill will be restricted to cases of Statin-Related Muscle Symptoms (SRMS)"

Colchicine 0.5 mg once daily

Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the guidelines. Drugs and doses will be left at the discretion of the treating physicians.

Matching Colchicine-placebo 0.5 mg once daily