Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians Using a Single PolyPill

NCT01271985 | Completed Phase 3 DMC

• 1 other identifier: DDRC.89.17
• Study Type: interventional
• Target: 8,410
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of PolyPill tablet (a fixed dose combination of two anti-hypertensive medications, atorvastatin and aspirin) on primary and secondary prevention of cardiovascular disease in Iranian adults older than 50.

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular Diseases; Drug Combinations; prevention and control; Aspirin; Antihypertensive Agents; Antilipemic Agents

Outcome Measures

Primary Outcomes (1)

• Time to first major cardiovascular event

  Major cardiovascular events are defined as: 1. Major coronary events include: sudden cardiac death, myocardial infarction, a diagnosis of angina, revascularization procedure 2. Cerebrovascular accidents (CVA) including transient ischemic attacks (TIA) 3. Hospitalization because of cardiovascular disease

  5 years

Secondary Outcomes (5)

• Blood pressure

  5 years

• Fasting blood sugar, total cholesterol, HDL-C and LDL-C

  5 years

• Number of Subjects Developing Adverse Events

  5 years

• Compliance

  5 years

• Rate of major cardiovascular events

  5 years

Study Arms (3)

PolyPill

ACTIVE COMPARATOR

PolyPill once daily and Minimal Care

Drug: PolyPill; Other: Minimal care

Minimal care

ACTIVE COMPARATOR

Minimal care.

Other: Minimal care

Usual care

NO INTERVENTION

Basic primary health care provided by the local physicians and Community Health Workers consistent with the current Iranian Health Care System guidelines.

Interventions

PolyPill DRUG

A combination tablet containing Aspirin 81 mg, enalapril 5 mg (or valsartan 40 mg), atorvastatin 20 mg and hydrochlorothiazide 12.5 mg taken once daily

Also known as: PolyPill 4-1, PolyPill 4-2

PolyPill

Minimal care OTHER

Health education pamphlet on reducing cardiovascular risk factors, direct education on reducing cardiovascular risk factors provided by the study physician and the Community Health Worker, biannual follow-up and BP measurement

Minimal care; PolyPill

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Enrollment in the Golestan Cohort Study

You may not qualify if:

• Hypersensitivity to any of PolyPill components:
• Hypersensitivity to Non-steroidal anti-inflammatory agents
• Hypersensitivity to statins
• Hypersensitivity to hydrochlorothiazide or sulfonamides
• Hypersensitivity to enalapril and valsartan
• Past medical history of angioedema
• Medical history of GI bleeding or peptic ulcer in the last 3 months
• Pregnancy or lactation
• Bleeding disorders such as hemophilia
• Receiving anticoagulation therapy
• Alcohol consumption greater than 40gr/week
• Advanced liver disease
• Uncontrolled seizures
• Asthma with any of the following criteria present:
• Daily symptoms

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Golestan University of Medical sciences: collaborator
• University of Birmingham: collaborator

Study Sites (1)

Golestan Cohort Study Center

Gonbad, Golestan Province, Iran

Location

Related Publications (21)

• 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 Aug;64(9):1220-7. doi: 10.1111/j.1742-1241.2010.02412.x.

  PMID: 20653798 BACKGROUND

• Lonn E, Bosch J, Teo KK, Pais P, Xavier D, Yusuf S. The polypill in the prevention of cardiovascular diseases: key concepts, current status, challenges, and future directions. Circulation. 2010 Nov 16;122(20):2078-88. doi: 10.1161/CIRCULATIONAHA.109.873232. No abstract available.

  PMID: 21098469 BACKGROUND

• Lonn E, Yusuf S. Polypill: the evidence and the promise. Curr Opin Lipidol. 2009 Dec;20(6):453-9. doi: 10.1097/MOL.0b013e32833305a3.

  PMID: 19884824 BACKGROUND

• Malekzadeh F, Pourshams A, Marshall T. The preventive polypill--much promise, insufficient evidence. Arch Iran Med. 2007 Jul;10(3):430-1. No abstract available.

  PMID: 17604490 BACKGROUND

• Majed M, Moradmand Badie S. A pilot double-blind randomised placebo-controlled trial of the effects of fixed-dose combination therapy ('polypill') on cardiovascular risk factors. Arch Iran Med. 2011 Jan;14(1):78-80. No abstract available.

  PMID: 21194270 BACKGROUND

• PILL Collaborative Group; Rodgers A, Patel A, Berwanger O, Bots M, Grimm R, Grobbee DE, Jackson R, Neal B, Neaton J, Poulter N, Rafter N, Raju PK, Reddy S, Thom S, Vander Hoorn S, Webster R. An international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk. PLoS One. 2011;6(5):e19857. doi: 10.1371/journal.pone.0019857. Epub 2011 May 25.

  PMID: 21647425 BACKGROUND

• Indian Polycap Study (TIPS); Yusuf S, Pais P, Afzal R, Xavier D, Teo K, Eikelboom J, Sigamani A, Mohan V, Gupta R, Thomas N. Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial. Lancet. 2009 Apr 18;373(9672):1341-51. doi: 10.1016/S0140-6736(09)60611-5. Epub 2009 Mar 30.

  PMID: 19339045 BACKGROUND

• Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ. 2003 Jun 28;326(7404):1419. doi: 10.1136/bmj.326.7404.1419.

  PMID: 12829553 BACKGROUND

• Wald DS, Wald NJ. Implementation of a simple age-based strategy in the prevention of cardiovascular disease: the Polypill approach. J Eval Clin Pract. 2012 Jun;18(3):612-5. doi: 10.1111/j.1365-2753.2011.01637.x. Epub 2011 Jan 30.

  PMID: 21276141 BACKGROUND

• Wald DS, Wald NJ. The Polypill in the prevention of cardiovascular disease. Prev Med. 2011 Jan;52(1):16-7. doi: 10.1016/j.ypmed.2010.11.015. Epub 2010 Dec 2. No abstract available.

  PMID: 21130112 BACKGROUND

• Rifai L, Khan BV. Do the current medical and economic times dictate the need for the "polypill"? J Clin Hypertens (Greenwich). 2009 Dec;11(12):775-6. doi: 10.1111/j.1751-7176.2009.00188.x. No abstract available.

  PMID: 20021541 BACKGROUND

• Soliman EZ, Mendis S, Dissanayake WP, Somasundaram NP, Gunaratne PS, Jayasingne IK, Furberg CD. A Polypill for primary prevention of cardiovascular disease: a feasibility study of the World Health Organization. Trials. 2011 Jan 5;12:3. doi: 10.1186/1745-6215-12-3.

  PMID: 21205325 BACKGROUND

• Sepanlou SG, Poustchi H, Kamangar F, Malekzadeh R. Effectiveness and feasibility of lifestyle and low-cost pharmacologic interventions in the prevention of chronic diseases: a review. Arch Iran Med. 2011 Jan;14(1):46-53.

  PMID: 21194261 BACKGROUND

• Sepanlou SG, Kamangar F, Poustchi H, Malekzadeh R. Reducing the burden of chronic diseases: a neglected agenda in Iranian health care system, requiring a plan for action. Arch Iran Med. 2010 Jul;13(4):340-50.

  PMID: 20597569 BACKGROUND

• Sanz G, Fuster V. Fixed-dose combination therapy and secondary cardiovascular prevention: rationale, selection of drugs and target population. Nat Clin Pract Cardiovasc Med. 2009 Feb;6(2):101-10. doi: 10.1038/ncpcardio1419. Epub 2008 Dec 23.

  PMID: 19104519 BACKGROUND

• Robinson JG, Maheshwari N. A "poly-portfolio" for secondary prevention: a strategy to reduce subsequent events by up to 97% over five years. Am J Cardiol. 2005 Feb 1;95(3):373-8. doi: 10.1016/j.amjcard.2004.09.036.

  PMID: 15670547 BACKGROUND

• Sarrafzadegan N, Talaei M, Sadeghi M, Kelishadi R, Oveisgharan S, Mohammadifard N, Sajjadieh AR, Kabiri P, Marshall T, Thomas GN, Tavasoli A. The Isfahan cohort study: rationale, methods and main findings. J Hum Hypertens. 2011 Sep;25(9):545-53. doi: 10.1038/jhh.2010.99. Epub 2010 Nov 25.

  PMID: 21107436 BACKGROUND

• Sanson-Fisher RW, Bonevski B, Green LW, D'Este C. Limitations of the randomized controlled trial in evaluating population-based health interventions. Am J Prev Med. 2007 Aug;33(2):155-61. doi: 10.1016/j.amepre.2007.04.007.

  PMID: 17673104 BACKGROUND

• Relton C, Torgerson D, O'Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. BMJ. 2010 Mar 19;340:c1066. doi: 10.1136/bmj.c1066. No abstract available.

  PMID: 20304934 BACKGROUND

• Dagenais GR, Pais P, Gao P, Roshandel G, Malekzadeh R, Joseph P, Yusuf S. Fixed dose combination therapies in primary cardiovascular disease prevention in different groups: an individual participant meta-analysis. Heart. 2023 Aug 24;109(18):1372-1379. doi: 10.1136/heartjnl-2022-322278.

  PMID: 37258095 DERIVED

• Roshandel G, Khoshnia M, Poustchi H, Hemming K, Kamangar F, Gharavi A, Ostovaneh MR, Nateghi A, Majed M, Navabakhsh B, Merat S, Pourshams A, Nalini M, Malekzadeh F, Sadeghi M, Mohammadifard N, Sarrafzadegan N, Naemi-Tabiei M, Fazel A, Brennan P, Etemadi A, Boffetta P, Thomas N, Marshall T, Cheng KK, Malekzadeh R. Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial. Lancet. 2019 Aug 24;394(10199):672-683. doi: 10.1016/S0140-6736(19)31791-X.

  PMID: 31448738 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Self-Care Units

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Reza Malekzadeh, M.D.

  Digestive Disease Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: January 7, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

IR (1)