Polypill For Prevention of Cardiovascular Disease

Condition(s) targeted: Cardiovascular Disease

Intervention: Red Heart Pill 2b (Polypill) (Drug); Usual Care (Other)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Wake Forest University

Official(s) and/or principal investigator(s):
Curt D Furberg, MD, PhD, Study Chair, Affiliation: Wake Forest University
Shanthi Mendis, MD, FRCP, Study Director, Affiliation: World Heath Organization
Elsayed Z Soliman, MD, MSc, Principal Investigator, Affiliation: Wake Forest University

Overall contact:
Elsayed Z Soliman, MD, MSc, Phone: 336-716-8632, Email: esoliman@wfubmc.edu

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). 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

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

Study design: Prevention, Randomized, Open Label, Parallel Assignment

Primary outcome:

Reduction of the estimated 10-year total cardiovascular risk score

Side effects (complaints)

Adherence

Secondary outcome:

Recruitment process

Physicians and patients acceptability to the polypill

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Estimated10-year total CVD risk score > 30%. 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.

Elsayed Z Soliman, MD, MSc, Phone: 336-716-8632, Email: esoliman@wfubmc.edu

The National Hospital of Sri Lanka, Colombo Colombo10, Sri Lanka

Starting date: January 2009
Ending date: March 2010
Last updated: June 3, 2008