Polypill For Prevention of Cardiovascular Disease - Full Text View

Sponsors and Collaborators:	Wake Forest University 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

Drug Information available for: Lisinopril Hydrochlorothiazide Simvastatin Acetylsalicylic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
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:	120
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 (5mg) 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:

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.

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
Colombo, Sri Lanka, Colombo10

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

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:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00567307
Health Authority:	United States: Institutional Review Board; Sri Lanka: Ministry of Healthcare & Nutrition

Study placed in the following topic categories:

Aspirin
Simvastatin
Lisinopril
Hydrochlorothiazide

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009