Polypill For Prevention of Cardiovascular Disease

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). We hypothesized that A "polypill" comprising the aforementioned four components would significantly reduce the estimated 10-year total CVD risk score with high adherence and no significant increase in adverse effects compared to the standard practice.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest School of Medicine; Wake Forest University Health Sciences
• Collaborators: National Hospital of Sri Lanka; World Health Organization
• Treatments: Hydrochlorothiazide

Criteria

Inclusion Criteria:

• Estimated 10-year total CVD risk score > 20%. 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:

• Patients with established angina pectoris, coronary heart disease, myocardial infarction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and/or carotid endarterectomy Left ventricular hypertrophy (on ECG) or hypertensive retinopathy (grade III or IV)

• 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 in child bearing period

• History of life-limiting diseases or events

• Unwillingness to sign informed consent.