Trial Information

The International Polycap Study 3 (TIPS-3) is a Randomized Double-blind Placebo-controlled Trial for the Evaluation of a Polycap, Low Dose Aspirin and Vitamin D Supplementation in Primary Prevention

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.