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Completed

NCT Number: NCT00603590

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

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.

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Key information

Conditions

Cardiovascular Disease Behavior Cardiovascular Diseases Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Heart Disease Heart Diseases Hyperlipidemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kalaleh Heart Study Center

Kalāleh, Golestan Province, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polypill

Drug

Fixed dose combination therapy - aspirin 81mg, hydrochlorothiazide 12.5mg, enalapril 2.5mg and atorvastatin 20mg Once daily

Placebo drug

Drug

Inactive tablet Once a day Identical in appearance to intervention drug

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: One year

    Systolic blood pressure. Mean of two seated measurements.

Secondary outcomes

  1. Diastolic Blood Pressure

    Time frame: One year

    Mean of two seated diastolic blood pressures

  2. LDL Cholesterol

    Time frame: One year

    Serum LDL cholesterol

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • University of Birmingham

Registry information

Official study title

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

Acronym: Polypill

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 29, 2008
Registry last updated
Oct 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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