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Arch Iran Med. 2020;23(8): 548-556.
doi: 10.34172/aim.2020.58
  Abstract View: 148
  PDF Download: 99

Study Protocol

Effectiveness of Polypill for Prevention of Cardiovascular Disease (PolyPars): Protocol of a Randomized Controlled Trial

Fatemeh Malekzadeh 1,2,3 ORCID logo, Abdullah Gandomkar 2, Zinab Malekzadeh 1, Hossein Poustchi 1,4, Mohsen Moghadami 2, Mohammad Reza Fattahi 5, Maryam Moini 5, Amir Anushiravani 1,2, Roozbeh Mortazavi 6, Shahrokh Sadeghi Boogar 6, Vahid Mohammadkarimi 6, Firoozeh Abtahi 7, Shahin Merat 1,8, Sadaf G. Sepanlou 1 * ORCID logo, Reza Malekzadeh 1,2,4,8

1 Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran
2 Non-Communicable Disease Research Center, Shiraz University of medical Sciences, Shiraz, Iran
3 Non-Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran
4 Digestive Oncology Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
5 Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
6 Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
7 Department of Cardiology, Cardiovascular Research Center School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
8 Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran
*Corresponding Author: Sadaf G. Sepanlou MD/MPH/PhD, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran. Address: Shariati Hospital, North Kargar Ave, Tehran, Iran. Postal Code: 14117-13135; Email: sepanlou@yahoo.com; Phone: +98 21 82415236; Fax: +98 21 82415400 sepanlou@yahoo.com

Abstract

Background: Cardiovascular diseases (CVDs) are the leading cause of death in Iran. A fixed-dose combination therapy (polypill) was proposed as a cost-effective strategy for CVD prevention, especially in lower-resource settings. We conducted the PolyPars trial to assess the effectiveness and safety of polypill for prevention of CVD.

Methods: The PolyPars trial is a pragmatic cluster randomized controlled trial nested within the Pars Cohort Study. Participants were randomized to an intervention arm and a control arm. Participants in the control arm received minimal non-pharmacological care, while those in the intervention arm received polypill in addition to minimal care. The polypill comprises hydrochlorothiazide 12.5 mg, aspirin 81 mg, atorvastatin 20 mg, and either enalapril 5 mg or valsartan 40 mg. The primary outcome of the study is defined as 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. The secondary outcomes of the study include adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up.

Results: From December 2014 to December 2015, 4415 participants (91 clusters) were recruited. Of those, 2200 were in the polypill arm and 2215 in the minimal care arm. The study is ongoing. This trial was registered with ClinicalTrials.gov number NCT03459560.

Conclusion: Polypill may be effective for primary prevention of CVDs in developing countries.

Keywords: Cardiovascular prevention, Non-communicable disease risk factors, Polypill
Cite this article as: Malekzadeh F, Gandomkar A, Malekzadeh Z, Poustchi H, Moghadami M, Fattahi MR, et al. Effectiveness of polypill for prevention of cardiovascular disease (PolyPars): protocol of a randomized controlled trial. Arch Iran Med. 2020;23(8):548–556. doi: 10.34172/aim.2020.58.
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Submitted: 24 May 2020
Accepted: 02 Jun 2020
ePublished: 01 Aug 2020
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