{ "abstract": "Aims: Although enteric-coated aspirin is widely used instead of chewable formulations in patients with atherosclerotic cardiovascular disease (ASCVD), its effects on cardiovascular and gastrointestinal outcomes remain uncertain. Separately, air pollution is a driver of cardiovascular risk, yet individual-level interventions have not been tested in outcomes trials.\n\nMethods and results: The Coated Or Chewable Aspirin in Patients with Established AThErosclerotic Disease and a Hybrid Strategy to Mitigate the Adverse Effects of AIR Pollution (COATED-AIR) is a randomized trial with a 2 × 2 factorial design planned to address these knowledge gaps. Patients with ASCVD receiving low-dose aspirin are considered for inclusion. Major exclusion criteria consist of being within 72 h of acute/unstable ASCVD or revascularization, triple antithrombotic therapy, active/recent bleeding, life expectancy <1 year, or other barriers or unwillingness for enrolment. Eligible consenting patients are randomized, in a double-blind fashion, to enteric-coated vs. chewable aspirin 81 mg daily and (via factorial randomization) to a hybrid strategy to mitigate the adverse effects of air pollution vs. usual care. The hybrid strategy includes (i) an educational flashcard, (ii) real-time air quality alerts via cellular text messages, and (iii) recommendations to (a) limit outdoor activity or (b) use a KN-95 facemask when outdoors, or (c) increase citrus fruit intake on days with elevated pollution levels. The primary efficacy outcome for the aspirin randomization is a composite of fatal/non-fatal ischaemic stroke, thrombotic/thromboembolic myocardial infarction, and acute limb ischaemia. For the AIR randomization, other forms of cardiovascular death are additionally included in the primary composite outcome. The median planned duration of follow-up is 2 years. Enrolment was completed on 28 January 2026. Clinical follow-up and blinded event adjudications are ongoing.\n\nConclusion: COATED-AIR will determine whether aspirin coating affects its safety or effectiveness, and whether individual-level strategies can mitigate cardiovascular risks from air pollution in patients with ASCVD.", "abstract_shown": true, "affiliations": [], "article_type": "research article", "arxiv": null, "author_total": 44, "authors": [ { "name": "Behnood Bikdeli", "orcid": "0000-0003-1428-879X" }, { "name": "Azita H Talasaz", "orcid": "0000-0003-1839-3685" }, { "name": "Hooman Bakhshandeh", "orcid": "0000-0002-5102-1501" }, { "name": "Mohammad Sadegh Hassanvand" }, { "name": "Hessam Kakavand", "orcid": "0000-0001-6719-4856" }, { "name": "Sepehr Jamalkhani", "orcid": "0000-0003-2054-389X" }, { "name": "Sina Rashedi" }, { "name": "Sara Tayyebi", "orcid": "0009-0001-4626-7750" }, { "name": "Mohammadreza Babaei", "orcid": "0000-0001-9279-9718" }, { "name": "Erfan Kohansal", "orcid": "0000-0002-4095-4824" }, { "name": "Hamed Ghoshouni", "orcid": "0000-0001-8949-2256" }, { "name": "Yasmin Mohtasham Kia", "orcid": "0000-0001-5796-2049" }, { "name": "Mahsa Nikkhoo", "orcid": "0000-0002-6106-3254" }, { "name": "Bahram Mohebbi", "orcid": "0000-0002-9207-6971" }, { "name": "Maryam Aghakouchakzadeh", "orcid": "0000-0003-0121-5989" }, { "name": "Saeed Alipour-Parsa", "orcid": "0000-0002-3305-2451" }, { "name": "Armin Elahifar", "orcid": "0000-0001-5667-3077" }, { "name": "Ehsan Khalilipur", "orcid": "0000-0001-5909-613X" }, { "name": "Razieh Omidvar", "orcid": "0000-0001-8581-721X" }, { "name": "Maryam Mehrpooya" }, { "name": "Seyed Hashem Sezavar" }, { "name": "David Jimenez", "orcid": "0000-0002-4571-7721" }, { "name": "Luis Jara Palomares", "orcid": "0000-0002-4125-3376" }, { "name": "Saeideh Mazloomzadeh", "orcid": "0000-0001-6325-0662" }, { "name": "Naser Hadavand" }, { "name": "Mehdi Ansari Dogaheh" }, { "name": "Majid Maleki" }, { "name": "Feridoun Noohi" }, { "name": "Luis Ortega-Paz", "orcid": "0000-0002-9567-3253" }, { "name": "Jayant K Raikhelkar", "orcid": "0000-0002-8561-7899" }, { "name": "Philippe Gabriel Steg", "orcid": "0000-0001-6896-2941" }, { "name": "Renato D Lopes", "orcid": "0000-0003-2999-4961" }, { "name": "Raffaele De Caterina", "orcid": "0000-0003-1637-574X" }, { "name": "Mehdi H Shishehbor" }, { "name": "Loren Laine", "orcid": "0000-0002-4296-7901" }, { "name": "Dominick J Angiolillo" }, { "name": "Sanjay Rajagopalan", "orcid": "0000-0001-6669-8163" }, { "name": "Ajay J Kirtane", "orcid": "0000-0003-0061-1058" }, { "name": "Gregory Piazza", "orcid": "0000-0002-1722-2983" }, { "name": "Gregory Y H Lip" }, { "name": "Roxana Mehran", "orcid": "0000-0002-5546-262X" }, { "name": "Harlan M Krumholz", "orcid": "0000-0003-2046-127X" }, { "name": "Paul M Ridker" }, { "name": "Parham Sadeghipour", "orcid": "0000-0001-9602-0513" } ], "bibtex": "https://research.draconitic.com/paper/ebzkjp4brg5w9.bib", "cited_by": 2, "doi": "10.1093/ehjcvp/pvag071", "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13730551/", "id": "ebzkjp4brg5w9", "issns": [ "2055-6837", "2055-6845" ], "landing_url": "https://doi.org/10.1093/ehjcvp/pvag071", "language": "en", "licence": "CC-BY-4.0", "licence_label": "CC BY 4.0", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by/4.0/", "metadata_licence": null, "native_subjects": [ [ "heading", "AcademicSubjects/MED00200" ], [ "heading", "AcademicSubjects/MED00410" ], [ "heading", "Chronic Coronary Syndromes" ], [ "heading", "Eurheartj/14" ], [ "heading", "Eurheartj/15" ], [ "heading", "Eurheartj/17" ], [ "heading", "Eurheartj/18" ], [ "heading", "Eurheartj/23" ], [ "heading", "Eurheartj/26" ], [ "heading", "Eurheartj/39" ], [ "heading", "Eurheartj/41" ], [ "heading", "Trial Design" ], [ "openalex", "2705|Antiplatelet Therapy and Cardiovascular Diseases" ] ], "openalex": "W7214072164", "pdf_url": "https://academic.oup.com/ehjcvp/advance-article-pdf/doi/10.1093/ehjcvp/pvag071/71320134/pvag071.pdf", "pmcid": "PMC13730551", "pmid": "42772753", "published": "2026-09-23", "publisher": "Oxford University Press", "ris": "https://research.draconitic.com/paper/ebzkjp4brg5w9.ris", "sources": [ { "first_seen": "2026-11-07T12:23:05Z", "native_id": "PMC13730551", "source": "pmc", "url": "https://doi.org/10.1093/ehjcvp/pvag071" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2705|Antiplatelet Therapy and Cardiovascular Diseases", "subfield": "cardiovascular" } ], "title": "Coated or chewable aspirin and a hybrid air pollution mitigation strategy in patients with atherosclerotic disease: rationale and design of the COATED-AIR randomized trial", "title_text": "Coated or chewable aspirin and a hybrid air pollution mitigation strategy in patients with atherosclerotic disease: rationale and design of the COATED-AIR randomized trial", "type": "peer-reviewed", "updated_at": "2026-11-07T12:23:05Z", "url": "https://research.draconitic.com/paper/ebzkjp4brg5w9", "venue": "European Heart Journal. Cardiovascular Pharmacotherapy", "versions": [] }