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ISRCTN
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ISRCTN43076122
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ClinicalTrials.gov identifier
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Public title
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Effect of a Polypill on middle-aged and elderly Iranians
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Scientific title
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Acronym
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Poly-Iran
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Serial number at source
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N/A
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Study hypothesis
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In individuals without raised blood pressure or raised cholesterol levels, but with a high incidence of cardiovascular disease because of their age, combination therapy with aspirin, antihypertensive drugs and a statin will reduce incidence of cardiovascular disease.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethics committee of the Digestive Disease Research Centre, Tehran University of Medical Sciences, approved of this pilot study on 11 March 2006. Further ethical approval will be sought for a full study.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Iran
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Disease/condition/study domain
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Cardiovascular disease in middle-aged and older adults.
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Participants - inclusion criteria
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1. Men between the ages of 50 and 80 (inclusive)
2. Women aged 55 to 80 (inclusive)
3. Living in Kalaleh
4. Free from existing cardiovascular disease (stroke, Transient Ischaemic Attack [TIA], Myocardial Infarction [MI], or angina)
5. Not currently be taking or eligible for antihypertensive treatment, aspirin or statins
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Participants - exclusion criteria
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1. Total cholesterol levels exceed 240 mg/dL
2. Blood pressure exceeds 160/100 mmHg at baseline
3. People with existing vascular disease
4. Clear indication or contra-indication for any component of the polypill or other chronic medical problems that would interfere with participation
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Anticipated start date
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01/10/2006
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Anticipated end date
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01/04/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Pilot study 500 participants. Full study - to be determined
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Interventions
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Current interventions as of 08/09/2008:
A combination therapy (polypill) consisting of aspirin 81 mg, hydrochlorothiazide 12.5 mg, enalapril 2.5 mg and atorvastatin 20 mg or an identical placebo.
Please note that these amendments are due to the errors in the information provided at time of registration.
Previous interventions:
A combination therapy (polypill) consisting of aspirin 75 mg, hydrochlorothiazide 1.25 mg, enalapril 2.5 mg and atorvastatin 10 mg or an identical placebo.
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Primary outcome measure(s)
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Combined cardiovascular events (MI, new onset angina, coronary artery surgery, stroke or sudden cardiac death)
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Secondary outcome measure(s)
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1. Total mortality
2. Gastrointestinal bleeding
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Sources of funding
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1. Digestive Disease Research Center, Tehran University of Medical Sciences (Iran)
2. Endocrine and Metabolic Reseach center, Tehran University of Medical Sciences (Iran)
3. Alborz daruo Pharmaceutical company (Iran)
4. Deputy for health, Iranian ministry of Health and Medical Education (Iran)
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20653798
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Contact name
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Dr
Tom
Marshall
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Address
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Department of Public Health and Epidemiology
University of Birmingham
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 7832
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Fax
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+44 (0)121 414 7878
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Email
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T.P.Marshall@bham.ac.uk
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Sponsor
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Ministry of Health and Medical Education (Iran)
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Address
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12th Floor
International Relations Office
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City/town
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Tehran
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Zip/Postcode
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-
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Country
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Iran
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Sponsor website:
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http://iad.takfab.ir/
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Date applied
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14/09/2006
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Last edited
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04/10/2011
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Date ISRCTN assigned
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19/10/2006
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