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Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease (Polypill)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603590
First Posted: January 29, 2008
Last Update Posted: October 2, 2009
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.
Collaborator:
University of Birmingham
Information provided by:
Tehran University of Medical Sciences
  Purpose

Cardiovascular is a major cause of mortality in Iran, accounting for 45.7% of deaths. In Golestan (North Eastern Iran) preliminary findings from follow-up of the Golestan Cohort are consistent with national figures: with 45% (at least 22 of 48 deaths) of all deaths attributed to cardiovascular events. Cardiovascular diseases will become an increasing problem as the Iranian population ages.

In 2003 Law and Wald proposed prevention of cardiovascular disease using fixed-dose combination therapy combining antihypertensive, lipid lowering and antiplatelet drugs in a single preparation. They proposed that this treatment should be offered to all persons at high risk of cardiovascular disease whether or not they have elevated blood pressure or elevated serum lipid concentrations.

This pilot study aims to investigate the safety and efficacy of fixed-dose combination therapy with two antihypertensive drugs, aspirin and atorvastatin in a population who would not currently be considered eligible for antihypertensive treatment or for lipid lowering treatment.

Methods:

This is a double-blind randomized controlled trial. The intervention group will be assigned to take a tablet consisting of a single daily tablet comprising Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg. The control group will be assigned to an identical placebo.

The population studied includes men aged 50 to 80 (inclusive) and women aged 55 to 80 (inclusive) who are currently not eligible for or taking antihypertensive or lipid lowering therapy. Persons who are found at baseline to have blood pressure >160/100 mm Hg, total cholesterol >240mg/dL, existing cardiovascular disease or to be taking antihypertensive ore lipid lowering therapy are excluded.

It is intended to randomize and follow up 500 subjects for 12 months. The primary outcome for the purpose of sample size calculation is change in systolic blood pressure. Additional outcomes include change in diastolic blood pressure, change in LDL cholesterol and occurrence of adverse events.


Condition Intervention Phase
Cardiovascular Disease Hypertension Hyperlipidemia Heart Disease Drug: Polypill Drug: Placebo drug Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase II Study of Heart Polypill in Primary Prevention of Cardiovascular Disease - Safety and Efficacy

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: One year ]

Secondary Outcome Measures:
  • Diastolic Blood Pressure [ Time Frame: One year ]
  • LDL Cholesterol [ Time Frame: One year ]

Enrollment: 475
Study Start Date: November 2006
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Polypill
Fixed dose combination therapy with Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg
Drug: Polypill
Fixed dose combination therapy - aspirin 81mg, hydrochlorothiazide 12.5mg, enalapril 2.5mg and atorvastatin 20mg Once daily
Placebo Comparator: Control
Identical placebo
Drug: Placebo drug
Inactive tablet Once a day Identical in appearance to intervention drug

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

All men over 50 to 80 and all women 55 to 80 who are resident in Kalaleh, Golestan, for at least one year.

Exclusion criteria

  • Existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina)
  • Already taking antihypertensive drugs, aspirin or statins
  • Already have clinical indications for treatment with antihypertensive drugs, aspirin or statins.

    • Blood pressure >160/100 mm Hg
    • Total Cholesterol > 240 mg/dL (or LDL >190 mg/dL)
  • Probable diabetes: HbA1c >6.0

Contraindication to a component of the Polypill

Contraindications to aspirin

  • Previous history of allergy to aspirin
  • History of peptic ulcer bleeding in whole life or endoscopic evidence of peptic ulcer within the past 3 months

Contraindications to statins

  • Liver failure Contraindications to further blood pressure lowering
  • Systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤70 mm Hg
  • Symptomatic postural hypotension
  • Difference between mean seated BP and standing BP greater than 20 mm Hg

Contraindications to thiazide

  • Uric acid >8 for men and uric acid >6 for women / gout (~10%)
  • Creatinine >1.2 mg/dl

Other predominant medical problem that may limit compliance with study treatment including:

  • History of alcohol abuse: more than 60cc for women and more than 80cc for men
  • History of drug abuse: IV drug abuser or eating or smoking more than 4 times a week
  • Limiting psychiatric illness (eg: mania, schizophrenia, severe depression, psychosis or dementia)
  • Limiting physical disability sufficient to prevent subject from walking
  • Other life-threatening condition such as cancer
  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): NCT00603590


Locations
Iran, Islamic Republic of
Kalaleh Heart Study Center
Kalaleh, Golestan, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
University of Birmingham
Investigators
Study Chair: Reza Malekzadeh, M.D. Tehran University of Medical Sciences
Principal Investigator: Fatemeh Malekzadeh, M.D. Tehran University of Medical Sciences
Principal Investigator: Mansoor Rastegarpanah, Ph.D. Tehran University of Medical Sciences
Study Chair: Kar K Cheng, PhD University of Birmingham
Principal Investigator: Tom P Marshall, PhD University of Birmingham
Study Director: Akram Pourshams, PhD Tehran University of Medical Sciences
  More Information

Publications:
Responsible Party: Reza Malekzadeh, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00603590     History of Changes
Other Study ID Numbers: 301/148
CCT-NAPN 15388
First Submitted: January 1, 2008
First Posted: January 29, 2008
Results First Submitted: April 13, 2009
Results First Posted: June 23, 2009
Last Update Posted: October 2, 2009
Last Verified: September 2009

Keywords provided by Tehran University of Medical Sciences:
Cardiovascular disease
primary prevention
Polypill
efficacy
safety
ADR
Diabetes
Adherence
Compliance

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action