Effect of a Polypill on middle-aged and elderly Iranians

ISRCTN	ISRCTN43076122
DOI	https://doi.org/10.1186/ISRCTN43076122
Protocol serial number	N/A
Sponsor	Ministry of Health and Medical Education (Iran)
Funders	Digestive Disease Research Center, Tehran University of Medical Sciences (Iran), Endocrine and Metabolic Reseach center, Tehran University of Medical Sciences (Iran), Alborz daruo Pharmaceutical company (Iran), Deputy for health, Iranian ministry of Health and Medical Education (Iran)

Submission date: 14/09/2006
Registration date: 19/10/2006
Last edited: 04/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tom Marshall
Scientific

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

Phone	+44 (0)121 414 7832
Email	T.P.Marshall@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Poly-Iran
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Aspirin, hydrochlorothiazide, enalapril and atorvastatin
Primary outcome measure(s)	Combined cardiovascular events (MI, new onset angina, coronary artery surgery, stroke or sudden cardiac death)
Key secondary outcome measure(s)	1. Total mortality 2. Gastrointestinal bleeding
Completion date	01/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	500
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	01/04/2008

Locations

Countries of recruitment

United Kingdom
England
Iran

Study participating centre

Department of Public Health and Epidemiology

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2010		Yes	No