At a glance
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The Feasibility of a Polypill Clinical Trial for Primary Prevention of Cardiovascular Disease: A Pilot Study
In Brief
A Phase 2 clinical trial evaluating Red Heart Pill 2b (Polypill) and Standard Practice for Cardiovascular Disease. Completed, enrolled 216 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)
Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions