The International Polycap Study 3 (TIPS-3) (TIPS-3)

• Composite of major CVD (CV death, non-fatal stroke, non-fatal MI), plus heart failure, resuscitated cardiac arrest, or revascularization with evidence of ischemia in participants taking Polycap versus placebo [ Time Frame: Particpants will be followed for an average of 5 years ] [ Designated as safety issue: No ]
  
• Composite of CV events (CV death, MI or stroke) and cancer in participants taking aspirin versus placebo [ Time Frame: Participants will be followed for an average of 5 years ] [ Designated as safety issue: No ]
  
• Risk of fractures in participants taking vitamin D versus placebo [ Time Frame: Participants will be followed for an average of 5 years ] [ Designated as safety issue: No ]
  

• Composite of CV death, non-fatal stroke, and nonfatal MI in participants taking Polycap versus placebo [ Time Frame: Participants will be followed for an average of 5 years ] [ Designated as safety issue: No ]
  
• Composite outcome of CV events and cancers after 10 years of follow up in participants taking aspirin versus placebo [ Time Frame: Participants will be followed for 10 years ] [ Designated as safety issue: No ]
  
• Composite outcome of CV events, fractures and cancers, and the risk of the falls at 10 years of follow up in participants taking vitamin D versus placebo [ Time Frame: Participants will be followed for 10 years ] [ Designated as safety issue: No ]
  

Cardiovascular disease (CVD), cancers and osteoporosis collectively make up the largest disease burden globally. CVD is the major cause of death and disability and affects about half of the population over their lifetimes. Cancers are a leading cause of death and it accounts for 13.0% of all deaths. The commonest forms include lung, breast, prostate, colorectum, stomach and liver cancer. It is estimated that over 200 hundred million people worldwide are living with osteoporosis. This is the underlying pathologic predisposition to fractures of the hip, vertebral body, and distal forearm. CVD, cancers and osteoporotic fractures increase with age and so their burden is expected to substantially increase over the next few decades. Simple, safe and effective preventive strategies which can reduce the incidence and prevalence of these 3 diseases are therefore urgently needed

It is suggested that this polypill could be given to all individuals with a CVD event as well as to anyone over 55 years (primary prevention) without the need for any measurement of risk factors. The polypill contains 3 blood pressure lowing medications and a statin in a single tablet. This includes hydrochlorothiazide (25 mg), atenolol (100 mg), ramipril (10 mg) and simvastatin (40 mg). In addition, to the polypill (Polycap), participants will be randomized to receive aspirin (75mg) and vitamin D (60,000 IU monthly). This factorial design on 3 distinct treatment arms which could reduce CVD, fractures and cancers could have large implications for the prevention of several of the important chronic diseases in middle and old age, using safe and inexpensive medications/supplements.