Table I.
Inclusion and exclusion criteria of TIPS-3
| Inclusion criteria: | 1. Men aged ≥50 years and women aged ≥55 years with an INTERHEART risk score ≥ 10, or men and women aged ≥65 years with an INTERHEART risk score of ≥5.⁎ 2. Provision of informed consent |
| Exclusion criteria: | 1. Participants with a clear clinical indication, contraindication, preference for or intolerance to statin, beta blocker (eg, bradycardia), ACE inhibitor, diuretic, aspirin or clopidogrel in the judgment of the physician. 2. Regular use of vitamin D at doses higher than 400 IU per day. 3. Hypercalcemia, hyperparathyroidism, osteomalacia or other contraindication or indication for vitamin D therapy. 4. Peptic ulcer disease, frequent dyspepsia or bleeding. 5. Expected long term use of anticoagulants 6. Known vascular disease. (eg, Stroke, TIA, Angina, MI, ACS, PVD including claudication and amputation). 7. Mean systolic BP below 120 mm Hg at run-in. 8. Symptomatic hypotension (eg, dizziness with SBP <110 mm Hg systolic) during the run-in phase. 9. Chronic liver disease or abnormal liver function, i.e. ALT or AST >3 × ULN. 10. Inflammatory muscle disease (such as dermatomyositis or polymyositis) or creatine kinase (CK) >3 × ULN. 11. Severe renal impairment (serum creatinine >264 μmol/L). 12. History of malignancy affecting any organ system, except basal cell carcinoma of the skin, within the previous 5 years. 13. Other serious condition(s) likely to interfere with study participation or with the ability to complete the trial. 14. Concurrent use of any experimental pharmacological agent. 15. Inability to attend follow-up as required by the protocol for at least 5 years. |
⁎
The original inclusion criteria for the study was men aged ≥55 years and women aged ≥60 years with an INTERHEART risk score ≥10. This was revised in February 2015 to include individuals at lower ages, as well as higher age groups with a lower INTERHEART risk score. This would still reflect an intermediate risk population (i.e. annual event rate >1%/year) since age is the strongest risk factor for CVD.