BACKGROUND: It is hypothesized that in individuals without clinical 
cardiovascular disease (CVD), but at increased CVD risk, a 50% to 60% reduction 
in CVD risk could be achieved using fixed dose combination (FDC) therapy 
(usually comprised of multiple blood-pressure agents and a statin [with or 
without aspirin]) in a single "polypill". However, the impact of a polypill in 
preventing clinical CV events has not been evaluated in a large randomized 
controlled trial.
METHODS: TIPS-3 is a 2x2x2 factorial randomized controlled trial that will 
examine the effect of a FDC polypill on major CV outcomes in a primary 
prevention population. This study aims to determine whether the Polycap 
(comprised of atenolol, ramipril, hydrochlorothiazide, and a statin) reduces CV 
events in persons without a history of CVD, but who are at least at intermediate 
CVD risk. Additional interventions in the factorial design of the study will 
compare the effect of (1) aspirin versus placebo on CV events (and cancer), (2) 
vitamin D versus placebo on the risk of fractures, and (3) the combined effect 
of aspirin and the Polycap on CV events.
RESULTS: The study has randomized 5713 participants across 9 countries. Mean age 
of the study population is 63.9 years, and 53% are female. Mean INTERHEART risk 
score is 16.8, which is consistent with a study population at intermediate CVD 
risk.
CONCLUSION: Results of the TIP-3 study will be key to determining the 
appropriateness of FDC therapy as a strategy in the global prevention of CVD.