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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

Phase 3
55 Years
Open (Enrolling)
Cardiovascular Disease, Fractures, Cancers

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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.

Inclusion Criteria:

- Men aged ≥ 55 years and women aged ≥ 60 years with and INTERHEART risk score of 10 or

- Provision of informed consent

Exclusion Criteria:

- Participants with a clear clinical indication, contraindication, preference for or
intolerance to statin, beta blocker (e.g. bradycardia), ACE inhibitor, diuretic,
aspirin or clopidogrel in the judgment of the physician

- Regular use of vitamin D at doses higher than 400 IU/day

- Hypercalcemia, hyperparathyroidism, osteomalacia or other contraindication or
indication for vitamin D therapy

- Peptic ulcer disease, frequent dyspepsia or bleeding

- Known vascular disease. (e.g. Stroke, TIA, Angina, MI, ACS, PVD including
claudication and amputation)

- Mean systolic BP below 120 mm Hg at run-in

- Symptomatic hypotension (e.g. dizziness with SBP < 110 mm Hg systolic) during the
run-in phase

- Chronic liver disease or abnormal liver function, i.e. ALT or AST > 3 x ULN

- Inflammatory muscle disease (such as dermatomyositis or polymyositis) or creatine
kinase (CK) > 3 x ULN.

- Severe renal impairment (serum creatinine > 264 µmol/L)

- History of malignancy affecting any organ system, except basal cell carcinoma of the
skin, within the previous 5 years

- Other serious condition(s) likely to interfere with study participation or with the
ability to complete the trial

- Concurrent use of any experimental pharmacological agent

- Inability to attend follow-up as required by the protocol for at least 5 years

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

Particpants will be followed for an average of 5 years

Safety Issue:


Principal Investigator

Salim Yusuf

Investigator Role:

Principal Investigator

Investigator Affiliation:

Population Health Research Institute


Canada: Health Canada

Study ID:




Start Date:

June 2012

Completion Date:

January 2019

Related Keywords:

  • Cardiovascular Disease
  • Fractures
  • Cancers
  • Cardiovascular Diseases
  • Fractures, Bone