Clinical trial NCT00567307: Polypill For Prevention of Cardiovascular Disease
Official title: The Feasibility of a Polypill Clinical Trial for Primary Prevention of Cardiovascular Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: National Hospital of Sri Lanka
First posted: 2007-12-04
Enrollment: 216
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Eligibility 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.

Primary outcomes:
measure: Reduction of the Estimated 10-year Total Cardiovascular Risk Score
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Colombo
country: Sri Lanka
facility: The National Hospital of Sri Lanka
city: Kandy
country: Sri Lanka
facility: Teaching (General) Hospital Kandy
city: Kegalle
country: Sri Lanka
facility: Teaching (General) Hospital Kegalle
Study officials:
affiliation: Wake Forest University Health Sciences
name: Elsayed Z Soliman, MD, MSc, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: World Heath Organization
name: Shanthi Mendis, MD, FRCP
role: STUDY_DIRECTOR
affiliation: Wake Forest University Health Sciences
name: Curt D Furberg, MD, PhD
role: STUDY_CHAIR
References:
citation: Soliman EZ, Mendis S, Dissanayake WP, Somasundaram NP, Gunaratne PS, Jayasingne IK, Furberg CD. A Polypill for primary prevention of cardiovascular disease: a feasibility study of the World Health Organization. Trials. 2011 Jan 5;12:3. doi: 10.1186/1745-6215-12-3.