The objective of the TIPS-3 study, is to evaluate a polypill (with and without aspirin) and vitamin D supplementation – compared to their respective placebos – in a primary prevention setting to reduce cardiovascular disease (CVD) outcomes.

It is hypothesized that in individuals without clinical cardiovascular disease, but at increased risk of CVD, a 50 to 60 percent 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 cardiovascular events has not been evaluated, before TIPS-3, in a large randomized controlled trial.

The 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.

Study Type

Interventional - Drug

Study Design

Randomized, double-blind, 2x2x2 factorial, placebo controlled

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