Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease

Exclusion Criteria

• •Existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina)
• •Already taking antihypertensive drugs, aspirin or statins
• •Already have clinical indications for treatment with antihypertensive drugs, aspirin or statins.
• •* Blood pressure \>160/100 mm Hg
• •* Total Cholesterol \> 240 mg/dL (or LDL \>190 mg/dL)
• •Probable diabetes: HbA1c \>6.0
• •Contraindication to a component of the Polypill
• •Contraindications to aspirin
• •Previous history of allergy to aspirin
• •History of peptic ulcer bleeding in whole life or endoscopic evidence of peptic ulcer within the past 3 months
• •Contraindications to statins
• •Liver failure Contraindications to further blood pressure lowering
• •Systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤70 mm Hg
• •Symptomatic postural hypotension
• •Difference between mean seated BP and standing BP greater than 20 mm Hg
• •Contraindications to thiazide
• •Uric acid \>8 for men and uric acid \>6 for women / gout (\~10%)
• •Creatinine \>1.2 mg/dl
• •Other predominant medical problem that may limit compliance with study treatment including:
• •History of alcohol abuse: more than 60cc for women and more than 80cc for men
• •History of drug abuse: IV drug abuser or eating or smoking more than 4 times a week
• •Limiting psychiatric illness (eg: mania, schizophrenia, severe depression, psychosis or dementia)
• •Limiting physical disability sufficient to prevent subject from walking
• •Other life-threatening condition such as cancer