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Polypill For Prevention of Cardiovascular Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567307
First Posted: December 4, 2007
Last Update Posted: June 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
World Health Organization
National Hospital of Sri Lanka
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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: None (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 Health Sciences:

Primary Outcome Measures:
  • Reduction of the Estimated 10-year Total Cardiovascular Risk Score [ Time Frame: Six months ]
    Estimated 10-year CVD total risk score were 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 were used for analysis. the score is based on systolic blood pressure and total cholesterol measures as well as on medical history data (monthly). Each one of these risk factors is assigned a point in the score and then linked to a table that mention the calculated CVD risk


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: The Red Heart Pill 2b (Polypill) (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: Standard Practice Group (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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Health Sciences
World Health Organization
National Hospital of Sri Lanka
Investigators
Principal Investigator: Elsayed Z Soliman, MD, MSc, MS Wake Forest University Health Sciences
Study Director: Shanthi Mendis, MD, FRCP World Heath Organization
Study Chair: Curt D Furberg, MD, PhD Wake Forest University Health Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00567307     History of Changes
Other Study ID Numbers: WFUBMC-IRB00004134
SLCTR/ 2007/012 ( Registry Identifier: Sri Lanka IRB )
First Submitted: November 30, 2007
First Posted: December 4, 2007
Results First Submitted: October 24, 2016
Results First Posted: December 16, 2016
Last Update Posted: June 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cardiovascular Diseases
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action