Prevention of Cardiovascular Disease With Polypill Among Pars Cohort Participants

NCT03459560 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4415

Last updated 2021-02-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PolyPill

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.

Sponsors & Collaborators

  • Shiraz University of Medical Sciences

    collaborator OTHER
  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Reza Malekzadeh, MD · Tehran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-20
Primary Completion
2022-03-20
Completion
2022-03-20

Countries

  • Iran

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03459560 on ClinicalTrials.gov