Cardiovascular disease
Conditions
Interventions
Intervention arm: Poplypill which is a combination of low dose aspirin, simvastatin, HCT and lisinopril control arm: usual care
Sponsors
World Health Organization Headquarter
Dr Reddy’s laboratories limited
Eligibility
Inclusion criteria
Inclusion criteria: More than 40 years Estimated 10-year total CVD risk score ? 30%. (The total CVD risk assessment will be based on the recently developed WHO CVD risk prediction charts) No contraindication for treatment with aspirin, angiotensin converting enzyme inhibitors, low-dose diuretics, or statins. Informed consent given
Exclusion criteria
Exclusion criteria: Patients with established angina pectoris, coronary heart disease, myocardial infraction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and /or carotid endarterectomy Left ventricular hypertrophy (on ECG) or hypertensive retinopathy (grade three or four) Patients with secondary hypertension Patients with diabetes type 1 or 2 with overt neuropathy or other significant renal disease Known renal failure or impairment Atrial fibrillation ALT > 1.5 times the upper limit of normal History of liver cirrhosis or hepatitis History of recent gastrointestinal bleeding (within the last year) Women of child bearing age History of life-limiting diseases or events Unwillingness to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Reduction in the estimated 10 year cardiovascular risk -Adherence to the study medication throughout the study (3 months) -Tolerability (the proportion of participants who withdraw due to side effects [] | — |
Secondary
| Measure | Time frame |
|---|---|
| •Acceptability of the polypill by physicians and patients •Introducing the newly developed WHOcardiovascular risk prediction charts •Improving the knowledge of participants to theircardiovascular risk factors •Building an infrastructure for internationalcollaborative research in cardiovascular disease [] | — |
Countries
Malawi,Sri Lanka
Contacts
Public ContactCurt D. Furberg MD PhD
Professor
Outcome results
None listed