Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Polypill For Prevention of Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
National Hospital of Sri Lanka
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00567307
First received: November 30, 2007
Last updated: May 25, 2010
Last verified: February 2009
  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 2

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 School of Medicine:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 School of Medicine
World Health Organization
National Hospital of Sri Lanka
Investigators
Principal Investigator: Elsayed Z Soliman, MD, MSc, MS Wake Forest School of Medicine
Study Director: Shanthi Mendis, MD, FRCP World Heath Organization
Study Chair: Curt D Furberg, MD, PhD Wake Forest School of Medicine
  More Information

No publications provided by Wake Forest School of Medicine

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

ClinicalTrials.gov processed this record on November 25, 2014