Polypill For Prevention of Cardiovascular Disease

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00567307
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Completed
Phase	Phase 2
Start date	January 2009
Completion date	January 2010

View Details

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