This trial is active, not recruiting.

Condition cardiovascular diseases
Treatment polypill
Phase phase 3
Sponsor Tehran University of Medical Sciences
Collaborator Golestan University of Medical Science
Start date October 2011
End date September 2017
Trial size 2400 participants
Trial identifier NCT01245608, DDRI/90.22


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Single daily dose of PolyPill and 6-monthly visits
polypill PolyPill 4-2
Polypill taken once daily for 5 years. Each pill contains acetylsalicylic acid 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg, valsartan 40 mg
(No Intervention)
Only 6-monthly visits

Primary Outcomes

Major Cardiovascular Events
time frame: 5 years

Secondary Outcomes

Side effects
time frame: 5 years
Changes in liver enzyme levels
time frame: 5 years
Changes in liver stiffness
time frame: 5 years
time frame: 5 years
Fat deposition
time frame: 5 years
All-cause Mortality
time frame: 5 years

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Being enrolled in Golestan Cohort Study Exclusion Criteria: - Debilitating disease causing inability to comply - Contraindications to any of the components of PolyPill - Not consenting to the study

Additional Information

Official title Fixed-dose Combination Therapy (PolyPill) in Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians - Focus on Liver-Related Variables.
Principal investigator Shahin Merat, M.D.
Description 2400 subjects will be randomly selected from participants of the Golestan Cohort Study (GCS) who are living in Gonbad and are over 50 years old. These subjects will be randomized to either receive PolyPill or no treatment. Those agreeing to the study will undergo additional measurements (in addition to the baseline measurements performed in the GCS) including liver-related tests such as liver enzyme levels, abdominal ultrasonography and liver stiffness measurement. Some additional tests such as color doppler ultrasonography of carotid vessels will also be performed. Subjects in the PolyPill arm who have no contraindication for the components of the pill will receive a single daily dose of PolyPill for 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Tehran University of Medical Sciences.