Polypill For Prevention of Cardiovascular Disease

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

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 Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Drug: Red Heart Pill 2b (Polypill); Other: 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

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sri Lanka
  • Colombo, Sri Lanka, Colombo10
    • The National Hospital of Sri Lanka
  • Kandy, Sri Lanka
    • Teaching (General) Hospital Kandy
  • Kegalle, Sri Lanka
    • Teaching (General) Hospital Kegalle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Red Heart Pill 2b (Polypill) (A); 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); 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); Other Names: Polypill
Active Comparator: Standard Practice Group (B); Standard Practice	Other: Standard Practice; Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions; Other Names: Usual care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: World Health Organization; National Hospital of Sri Lanka
• Investigators: Principal Investigator: Elsayed Z Soliman, MD, MSc, MS, Wake Forest University Health Sciences; Study Director: Shanthi Mendis, MD, FRCP, World Heath Organization; Study Chair: Curt D Furberg, MD, PhD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: November 30, 2007
• First Submitted That Met QC Criteria: November 30, 2007
• First Posted (Estimate): December 4, 2007

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: IRB00004134; SLCTR/ 2007/012 (Registry Identifier: Sri Lanka IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes