NCT01245608

Brief Summary

The primary purpose of this study is to determine the effects of a fixed dose combination of valsartan, hydrochlorothiazide, atorvastatin and aspirin (PolyPill) on prevention of cardiovascular events in adults older than 50. Various liver-related variables will also be recorded which will allow studying the effects of PolyPill on the liver and the effect of liver diseases such as nonalcoholic steatohepatitis on cardiovascular events and the protective effect of PolyPill.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,400

participants targeted

Target at P75+ for phase_3 cardiovascular-diseases

Timeline
Completed

Started Oct 2011

Typical duration for phase_3 cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2018

Enrollment Period

6.3 years

First QC Date

November 19, 2010

Last Update Submit

February 12, 2019

Conditions

Cardiovascular Diseases

Keywords

AtorvastatinAspirinnonalcoholic steatohepatitisnonalcoholic fatty liver diseaseantihypertensive agents

Outcome Measures

Primary Outcomes (1)

  • Major Cardiovascular Events

    The first occurrence of hospitalization for acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden death, new-onset heart failure, coronary artery revascularization procedures and stroke (fatal or non-fatal).

    5 years

Secondary Outcomes (6)

  • Side effects

    5 years

  • Changes in liver enzyme levels

    5 years

  • Changes in liver stiffness

    5 years

  • Compliance

    5 years

  • Fat deposition

    5 years

  • +1 more secondary outcomes

Study Arms (2)

Polypill

EXPERIMENTAL

Single daily dose of PolyPill and 6-monthly visits

Drug: Polypill

Control

NO INTERVENTION

Only 6-monthly visits

Interventions

PolypillDRUG

Polypill taken once daily for 5 years. Each pill contains acetylsalicylic acid 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg, valsartan 40 mg

Also known as: PolyPill 4-2
Polypill

Eligibility Criteria

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

You may qualify if:

  • \- Being enrolled in Golestan Cohort Study

You may not qualify if:

  • Debilitating disease causing inability to comply
  • Contraindications to any of the components of PolyPill
  • Not consenting to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golestan Cohort Center

Gonbad, Golestan Province, Iran

Location

Related Publications (4)

  • Pourshams A, Khademi H, Malekshah AF, Islami F, Nouraei M, Sadjadi AR, Jafari E, Rakhshani N, Salahi R, Semnani S, Kamangar F, Abnet CC, Ponder B, Day N, Dawsey SM, Boffetta P, Malekzadeh R. Cohort Profile: The Golestan Cohort Study--a prospective study of oesophageal cancer in northern Iran. Int J Epidemiol. 2010 Feb;39(1):52-9. doi: 10.1093/ije/dyp161. Epub 2009 Mar 30. No abstract available.

    PMID: 19332502BACKGROUND

  • 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

  • Merat S, Jafari E, Radmard AR, Khoshnia M, Sharafkhah M, Nateghi Baygi A, Marshall T, Shiravi Khuzani A, Cheng KK, Poustchi H, Malekzadeh R. Polypill for prevention of cardiovascular diseases with focus on non-alcoholic steatohepatitis: the PolyIran-Liver trial. Eur Heart J. 2022 Jun 1;43(21):2023-2033. doi: 10.1093/eurheartj/ehab919.

    PMID: 35048107DERIVED

  • Merat S, Poustchi H, Hemming K, Jafari E, Radmard AR, Nateghi A, Shiravi Khuzani A, Khoshnia M, Marshall T, Malekzadeh R. PolyPill for Prevention of Cardiovascular Disease in an Urban Iranian Population with Special Focus on Nonalcoholic Steatohepatitis: A Pragmatic Randomized Controlled Trial within a Cohort (PolyIran - Liver) - Study Protocol. Arch Iran Med. 2015 Aug;18(8):515-23.

    PMID: 26265520DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Reza Malekzadeh, M.D.

    Tehran University of Medical Sciences

    STUDY CHAIR

  • Shahin Merat, M.D.

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

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

November 19, 2010

First Posted

November 22, 2010

Study Start

October 1, 2011

Primary Completion

January 1, 2018

Study Completion

September 1, 2018

Last Updated

February 15, 2019

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)