Health Condition 1: null- Hypertension, diabetes mellitus, hypercholesterolemia
Conditions
Interventions
Intervention1: Polycap (Thiazide25mg, Atenolol 100mg, Ramipril 10mg, Simvastatin 40 mg)
Aspirin 75mg
Vitamin D(60,000): Polycap containing four drugs versus placebo given once a day orally until study
Sponsors
Cadila Pharmaceutical Private Limited
Population Health Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men aged >= 50 years and women aged >= 55 years, with an INTERHEART risk score of 10 or greater; OR Men or women aged >= 65 years, with an INTERHEART risk score of 5 or greater 2. Provision of informed consent
Exclusion criteria
Exclusion criteria: 1. Participant with a clear indication, contraindication, preference for or intolerance to statin, beta blocker (eg. bradycardia), ACE inhibitor, diuretic, aspirin or clopidogerel in the judgment of the physician. 2. Regular use of vitamin D at dos 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. Known vascular disease. (eg. Stroke, TIA, Angina, MI, ACS, PVD including claudication and amputation). 6. Mean systolic BP below 120 mm Hg at run-in. 7. Symptomatic hypotension (eg. Dizziness with SBP 8. Chronic liver disease or abnormal liver function, i.e. ALT or AST >3 x ULN. 9. Inflammatory muscle disease (such as dermatomyositis or polymyositis) or creatine kinase (CK) > 3x ULN. 10. Severe renal impairment (serum creatinine >264 µmol/L). 11. History of malignancy affecting any organ system, except basal cell carcinoma of the skin, within the previous 5 years. 12. Other serious conditions(s) likely to interfere with study participation or with the ability to complete the trial. 13. Concurrent use of any experimental pharmacological agent. 14. Inability to attend follow-up as required by the protocol for at least 5 years. 15. Expected long term use of anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of CV death, Non fatal stroke, Non fatal MI.Timepoint: Every six months for an average follow up period of five years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart failure, Resuscitated cardiac arrest, RevascularizationTimepoint: Every six months for an average follow up period of five years. | — |
Countries
Bangladesh, Canada, Colombia, India, Indonesia, Malaysia, Philippines, Tunisia
Contacts
Public ContactDr Alben Sigamani
St Johns Research Institute, St Johns National Academy of Health Sciences
Outcome results
None listed