Polypill For Prevention of Cardiovascular Disease

NCT ID: NCT00567307

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-01-31

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

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Red Heart Pill 2b (Polypill)

Intervention Type: DRUG

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)

Standard Practice Group (B)

Standard Practice

Group Type: ACTIVE_COMPARATOR

Standard Practice

Intervention Type: OTHER

Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions

Interventions

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)

Intervention Type: DRUG

Standard Practice

Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions

Intervention Type: OTHER

Other Intervention Names

Polypill; Usual care

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

National Hospital of Sri Lanka

OTHER_GOV

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elsayed Z Soliman, MD, MSc, MS

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Shanthi Mendis, MD, FRCP

Role: STUDY_DIRECTOR

World Heath Organization

Curt D Furberg, MD, PhD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

The National Hospital of Sri Lanka

Colombo, , Sri Lanka

Teaching (General) Hospital Kandy

Kandy, , Sri Lanka

Teaching (General) Hospital Kegalle

Kegalle, , Sri Lanka

Countries

Sri Lanka

References

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.

Reference Type: DERIVED

PMID: 21205325 (View on PubMed)

Other Identifiers

SLCTR/ 2007/012

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB00004134

Identifier Type: -

Identifier Source: org_study_id