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). 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.

Condition	Intervention	Phase
Cardiovascular Disease	Drug: Red Heart Pill 2b (Polypill) Other: Standard Practice	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

Resource links provided by NLM:

Drug Information available for: Hydrochlorothiazide

U.S. FDA Resources

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 ]
Estimated 10-year CVD total risk score will be 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 will be used for analysis.

Secondary Outcome Measures:

Adherence [ Time Frame: Six months ] [ Designated as safety issue: No ]
Adherence will be measured using the the pill count and self report method assisted by participants' diary form. Adherence will be measured as: Percentage of prescribed doses taken, percentage of treatment days during which the prescribed number of doses were taken, drug holidays (3 or more consecutive days without drug intake) and persistence (time between initiation and discontinuation of therapy.
Side effects [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
Side effects and complaints will be asked for in each of the follow up visits. Specific questions about anticipated side effects and general inquiry about other complaints will be addressed
Physician and patient acceptability [ Time Frame: Six months ] [ Designated as safety issue: No ]
Acceptability will be based on views of participants and physicians regarding single daily dose therapy with combined pill; the Polypill. Patient acceptability will be measured in participants who will complete the study as well as those who will be screened but not eligible. Physician acceptability will be assessed in a random sample of local physicians in Sri Lanka.
Recruitment and retention [ Time Frame: Six months ] [ Designated as safety issue: No ]
Recruitment and retention process will be evaluated in terms of the timelines of recruitment of the participants as well as the proportion of participants who will complete the study.

Enrollment:	216
Study Start Date:	January 2009
Study Completion Date:	January 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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 Name: Polypill
Active Comparator: 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 Name: Usual care

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

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

Locations

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

Sponsors and Collaborators

Wake Forest University

World Health Organization

National Hospital of Sri Lanka

Investigators

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

More Information

No publications provided by Wake Forest University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Curt D. Furberg MD, PhD/ Professor, Wake Forest University School of Medicine
ClinicalTrials.gov Identifier:	NCT00567307 History of Changes
Other Study ID Numbers:	WFUBMC-IRB00004134, SLCTR/ 2007/012
Study First Received:	November 30, 2007
Last Updated:	May 25, 2010
Health Authority:	United States: Institutional Review Board; Sri Lanka: Ministry of Healthcare & Nutrition

Additional relevant MeSH terms:

Cardiovascular Diseases
Hydrochlorothiazide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012