Polypill For Prevention of Cardiovascular Disease - Full Text View

Sponsor:	Wake Forest University
Collaborators:	World Health Organization National Hospital of Sri Lanka
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00567307

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Disease	Drug: Red Heart Pill 2b (Polypill) Other: Usual Care	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	The Feasibility of a Polypill Clinical Trial for Primary Prevention of Cardiovascular Disease: A Pilot Study

Further study details as provided by Wake Forest University:

Primary Outcome Measures:

Reduction of the estimated 10-year total cardiovascular risk score [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
Side effects (complaints) [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
Adherence [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Recruitment process [ Time Frame: Six months ] [ Designated as safety issue: No ]
Physicians and patients acceptability to the polypill [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	January 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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 (10 mg), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)
B: Active Comparator	Other: Usual Care Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567307

Contacts

Contact: Elsayed Z Soliman, MD, MSc	336-716-8632	esoliman@wfubmc.edu
Contact: Curt D Furberg, MD, PhD	336-716-3730	cfurberg@wfubmc.edu

Locations

Sri Lanka
The National Hospital of Sri Lanka	Recruiting
Colombo, Sri Lanka, Colombo10
Principal Investigator: Noel Somasundaram, MBBS MD MRCP CCD
Teaching (General) Hospital Kegalle	Recruiting
Kegalle, Sri Lanka
Contact: Wasantha P Dissanayake, MBBS, DCH, MD
Principal Investigator: Wasantha P Dissanayake, MBBS, DCH, MD

Sponsors and Collaborators

Wake Forest University

World Health Organization

National Hospital of Sri Lanka

Investigators

Study Chair:	Curt D Furberg, MD, PhD	Wake Forest University
Study Director:	Shanthi Mendis, MD, FRCP	World Heath Organization
Principal Investigator:	Elsayed Z Soliman, MD, MSc	Wake Forest University

More Information

No publications provided

Responsible Party:	Wake Forest University School of Medicine ( Curt D. Furberg MD, PhD/ Professor )
Study ID Numbers:	WFUBMC-IRB00004134, SLCTR/ 2007/012
Study First Received:	November 30, 2007
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00567307 History of Changes
Health Authority:	United States: Institutional Review Board; Sri Lanka: Ministry of Healthcare & Nutrition

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on March 18, 2010