The International Polycap Study 3 (TIPS-3)

• Status: Completed
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

Summary

The randomized 2x2x2 factorial design placebo controlled trial will enroll 5000 participants (women 60 years or older and men 55 years or older) without known heart disease or prior stroke and without a clear indication or contraindication to any of the study medications. Eligible and consenting individuals will be randomized to receive either the active study medications or placebo (dummy pills) and will be monitored for an average of 5 years. The study will include people from at 10 countries, will be conducted by an international group of scientists and physicians and will be coordinated by the Population Health Research Institute at Hamilton Health Sciences.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Collaborators: Cadila Pharnmaceuticals; Canadian Institutes of Health Research (CIHR); Heart and Stroke Foundation of Ontario; Wellcome Trust
• Treatments: Aspirin; Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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.

• 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 per day.

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

• Peptic ulcer disease, frequent dyspepsia or bleeding.

• Expected long term use of anticoagulants

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

• Mean systolic BP (using 2 automatic readings) 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.