Polypill For Prevention of Cardiovascular Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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This is an open-label, parallel-group, randomized clinical trial comparing a Polypill to Standard Practice (defined as usual care administered to patients with similar conditions). Approximately 200 participants will be recruited from three sites in Sri Lanka: The National Hospital of Sri Lanka, Colombo; Teaching Hospital, Kegalle, and Teaching Hospital, Kandy. Subsequent to granting written informed consent, patients will undergo screening and baseline evaluation to confirm eligibility, followed by randomization to the Polypill or to the Standard Practice study arm. Patients receiving either intervention will return for a total of three monthly clinic visits. Physician acceptability will be evaluated through a five-question survey will be mailed to a random sample of physicians from the participating clinical sites and to the Council of General Practitioners in Sri Lanka. Patient acceptability will be measured in participants who will complete the study as well as those who will be screened but not eligible

Official Title
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The Feasibility of a Polypill Clinical Trial for Primary Prevention of Cardiovascular Disease: A Pilot Study

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: Red Heart Pill 2b (Polypill)
* Other: Standard Practice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Red Heart Pill 2b (Polypill) (A)<br>The Polypill is composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide | Drug: Red Heart Pill 2b (Polypill)<br>* 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)<br>* Other names: Polypill;|
| Active Comparator: Standard Practice Group (B)<br>Standard Practice | Other: Standard Practice<br>* Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions<br>* Other names: Usual care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the Estimated 10-year Total Cardiovascular Risk Score | Estimated 10-year CVD total risk score were calculated in the field centers and in the Coordinating Center from the measures of blood pressure and total cholesterol and from the medical history data collected during each visit using the WHO CVD prediction chart. The estimated 10-year CVD total risk calculated by the Coordinating Center were used for analysis. the score is based on systolic blood pressure and total cholesterol measures as well as on medical history data (monthly). Each one of these risk factors is assigned a point in the score and then linked to a table that mention the calculated CVD risk | Six months |