NCT03459560

Brief Summary

The purpose of this study is to determine the effects of a fixed dose combination of enalapril (or valsartan), with hydrochlorthiazide, atorvastatin and acetylsalicylic acid (PolyPill) on primary and secondary prevention of cardiovascular disease in participants of Pars Cohort of Iran.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,415

participants targeted

Target at P75+ for phase_3 cardiovascular-diseases

Timeline
Completed

Started Dec 2015

Typical duration for phase_3 cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

February 10, 2021

Status Verified

January 1, 2021

Enrollment Period

6.3 years

First QC Date

March 3, 2018

Last Update Submit

February 5, 2021

Conditions

Cardiovascular Diseases

Keywords

fixed-dose combination therapyPolypillPreventionCardiovascular diseases

Outcome Measures

Primary Outcomes (1)

  • Major Cardiovascular Events (MCVE)

    the first occurrence of acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden cardiac death, new-onset heart failure, coronary artery revascularization procedures, transient ischemic attack, cerebrovascular accidents (fatal or non-fatal), and hospitalization due to any of the mentioned conditions.

    5 years

Secondary Outcomes (9)

  • Number of Subjects Developing Adverse Events

    5 years

  • Compliance

    5 years

  • Non cardiovascular mortality

    5 years

  • Level of fasting blood sugar (mg/dL)

    5 years

  • Level of blood pressure (mmHg)

    5 years

  • +4 more secondary outcomes

Study Arms (2)

PolyPill

EXPERIMENTAL

Single daily dose of PolyPill and minimal care.

Drug: PolyPill

Control

NO INTERVENTION

Only minimal care

Interventions

PolyPillDRUG

After the baseline enrollment and excluding non-eligible participants, we randomized villages to Polypill and control arms. Follow-ups are scheduled for 1, 3, and 6 months after the initial enrollment in the Polypill arm and every six months thereafter. For the minimal care arm, the follow-ups are arranged every six months.

Also known as: PolyPill-E, Polypill-V
PolyPill

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Enrollment in the Pars Cohort Study

You may not qualify if:

  • Not consenting to participate in the study
  • 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 regular anticoagulation therapy
  • Alcohol consumption greater than 40gr/week
  • Advanced liver disease
  • Uncontrolled seizures
  • Asthma with any of the following criteria present:
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pars Cohort Center

Shiraz, Fars, Iran

Location

Related Publications (12)

  • 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: 31448738BACKGROUND

  • 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: 20653798BACKGROUND

  • Ostovaneh MR, Poustchi H, Hemming K, Marjani H, Pourshams A, Nateghi A, Majed M, Navabakhsh B, Khoshnia M, Jaafari E, Mohammadifard N, Malekzadeh F, Merat S, Sadeghi M, Naemi M, Etemadi A, Thomas GN, Sarrafzadegan N, Cheng KK, Marshall T, Malekzadeh R. Polypill for the prevention of cardiovascular disease (PolyIran): study design and rationale for a pragmatic cluster randomized controlled trial. Eur J Prev Cardiol. 2015 Dec;22(12):1609-17. doi: 10.1177/2047487314550803. Epub 2014 Sep 17.

    PMID: 25230980BACKGROUND

  • 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: 21098469BACKGROUND

  • 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: 17604490BACKGROUND

  • 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: 21194270BACKGROUND

  • 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: 21647425BACKGROUND

  • Yusuf S, Pais P, Sigamani A, Xavier D, Afzal R, Gao P, Teo KK. Comparison of risk factor reduction and tolerability of a full-dose polypill (with potassium) versus low-dose polypill (polycap) in individuals at high risk of cardiovascular diseases: the Second Indian Polycap Study (TIPS-2) investigators. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):463-71. doi: 10.1161/CIRCOUTCOMES.111.963637. Epub 2012 Jul 10.

    PMID: 22787067BACKGROUND

  • 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: 19339045BACKGROUND

  • 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: 12829553BACKGROUND

  • Malekzadeh F, Gandomkar A, Poustchi H, Etemadi A, Roshandel G, Attar A, Abtahi F, Sadeghi Boogar S, Mohammadkarimi V, Fattahi MR, Mohagheghi A, Malekzadeh R, Sepanlou SG. Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars). Heart. 2024 Jun 25;110(14):940-946. doi: 10.1136/heartjnl-2023-323614.

    PMID: 38485210DERIVED

  • Malekzadeh F, Gandomkar A, Malekzadeh Z, Poustchi H, Moghadami M, Fattahi MR, Moini M, Anushiravani A, Mortazavi R, Sadeghi Boogar S, Mohammadkarimi V, Abtahi F, Merat S, Sepanlou SG, Malekzadeh R. Effectiveness of Polypill for Prevention of Cardiovascular Disease (PolyPars): Protocol of a Randomized Controlled Trial. Arch Iran Med. 2020 Aug 1;23(8):548-556. doi: 10.34172/aim.2020.58.

    PMID: 32894967DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Reza Malekzadeh, MD

    Tehran University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2018

First Posted

March 9, 2018

Study Start

December 20, 2015

Primary Completion

March 20, 2022

Study Completion

March 20, 2022

Last Updated

February 10, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)