Condition category
Circulatory System
Date applied
14/09/2006
Date assigned
19/10/2006
Last edited
04/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tom Marshall

ORCID ID

Contact details

Department of Public Health and Epidemiology
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7832
T.P.Marshall@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Poly-Iran

Study hypothesis

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.

Ethics approval

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular disease in middle-aged and older adults.

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Aspirin, hydrochlorothiazide, enalapril and atorvastatin

Primary outcome measures

Combined cardiovascular events (MI, new onset angina, coronary artery surgery, stroke or sudden cardiac death)

Secondary outcome measures

1. Total mortality
2. Gastrointestinal bleeding

Overall trial start date

01/10/2006

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Pilot study 500 participants. Full study - to be determined

Participant exclusion criteria

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

Recruitment start date

01/10/2006

Recruitment end date

01/04/2008

Locations

Countries of recruitment

Iran

Trial participating centre

Department of Public Health and Epidemiology
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

Ministry of Health and Medical Education (Iran)

Sponsor details

12th Floor
International Relations Office
Tehran
-
Iran

Sponsor type

Government

Website

http://iad.takfab.ir/

Funders

Funder type

Hospital/treatment centre

Funder name

Digestive Disease Research Center, Tehran University of Medical Sciences (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Endocrine and Metabolic Reseach center, Tehran University of Medical Sciences (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Alborz daruo Pharmaceutical company (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Deputy for health, Iranian ministry of Health and Medical Education (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20653798

Publication citations

  1. Results

    Malekzadeh F, Marshall T, Pourshams A, Gharravi M, Aslani A, Nateghi A, Rastegarpanah M, Khoshnia M, Semnani S, Salahi R, Thomas GN, Larijani B, Cheng KK, Malekzadeh R, A pilot double-blind randomised placebo-controlled trial of the effects of fixed-dose combination therapy ('polypill') on cardiovascular risk factors., Int. J. Clin. Pract., 2010, 64, 9, 1220-1227, doi: 10.1111/j.1742-1241.2010.02412.x.

Additional files

Editorial Notes