Effect of a Polypill on middle-aged and elderly Iranians
| ISRCTN | ISRCTN43076122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43076122 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Public Health and Epidemiology
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 7832 |
|---|---|
| T.P.Marshall@bham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aspirin, hydrochlorothiazide, enalapril and atorvastatin |
| Primary outcome measure | 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 study start date | 01/10/2006 |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Pilot study 500 participants. Full study - to be determined |
| 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
- England
- Iran
- United Kingdom
Study participating centre
Department of Public Health and Epidemiology
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
Ministry of Health and Medical Education (Iran)
Government
Government
12th Floor
International Relations Office
Tehran
-
Iran
| Website | http://iad.takfab.ir/ |
|---|---|
"ROR" |
https://ror.org/01rs0ht88 |
Funders
Funder type
Hospital/treatment centre
Digestive Disease Research Center, Tehran University of Medical Sciences (Iran)
No information available
Endocrine and Metabolic Reseach center, Tehran University of Medical Sciences (Iran)
No information available
Alborz daruo Pharmaceutical company (Iran)
No information available
Deputy for health, Iranian ministry of Health and Medical Education (Iran)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
