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.
Although enteric-coated aspirin is widely used instead of chewable formulations in patients with atherosclerotic cardiovascular diseases (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.
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 2x2 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 hours of acute/unstable ASCVD or revascularization, triple antithrombotic therapy, active/recent bleeding, life expectancy <1 year, or other barriers or unwillingness for enrollment. Eligible consenting patients are randomized, in a double-blind fashion, to enteric coated vs chewable aspirin 81mg daily, and (via factorial randomization) to a hybrid strategy to mitigate the adverse effects of air pollution vs usual care. The hybrid strategy includes 1. an educational flashcard, 2. real-time air quality alerts via cellular text messages, and recommendations to 2a. limit outdoor activity or 2b. to use a KN-95 facemask when outdoors, and 2c. to increase citrus fruit intake on days with elevated pollution levels. The primary efficacy outcome for the aspirin randomization is a composite of fatal/nonfatal ischemic stroke, thrombotic/thromboembolic myocardial infarction, and acute limb ischemia. 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. Enrollment was completed on 01/28/2026. Clinical follow-up and blinded event adjudications are ongoing.
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.
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 2x2 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 hours of acute/unstable ASCVD or revascularization, triple antithrombotic therapy, active/recent bleeding, life expectancy <1 year, or other barriers or unwillingness for enrollment. Eligible consenting patients are randomized, in a double-blind fashion, to enteric coated vs chewable aspirin 81mg daily, and (via factorial randomization) to a hybrid strategy to mitigate the adverse effects of air pollution vs usual care. The hybrid strategy includes 1. an educational flashcard, 2. real-time air quality alerts via cellular text messages, and recommendations to 2a. limit outdoor activity or 2b. to use a KN-95 facemask when outdoors, and 2c. to increase citrus fruit intake on days with elevated pollution levels. The primary efficacy outcome for the aspirin randomization is a composite of fatal/nonfatal ischemic stroke, thrombotic/thromboembolic myocardial infarction, and acute limb ischemia. 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. Enrollment was completed on 01/28/2026. Clinical follow-up and blinded event adjudications are ongoing.
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.
Authors
Bikdeli Bikdeli, Talasaz Talasaz, Bakhshandeh Bakhshandeh, Hassanvand Hassanvand, Kakavand Kakavand, Jamalkhani Jamalkhani, Rashedi Rashedi, Tayyebi Tayyebi, Babaei Babaei, Kohansal Kohansal, Ghoshouni Ghoshouni, Mohtasham Kia Mohtasham Kia, Nikkhoo Nikkhoo, Mohebbi Mohebbi, Aghakouchakzadeh Aghakouchakzadeh, Alipour-Parsa Alipour-Parsa, Elahifar Elahifar, Khalilipur Khalilipur, Omidvar Omidvar, Mehrpooya Mehrpooya, Sezavar Sezavar, Jimenez Jimenez, Jara Palomares Jara Palomares, Mazloomzadeh Mazloomzadeh, Hadavand Hadavand, Ansari Dogaheh Ansari Dogaheh, Maleki Maleki, Noohi Noohi, Ortega-Paz Ortega-Paz, Raikhelkar Raikhelkar, Steg Steg, Lopes Lopes, De Caterina De Caterina, Shishehbor Shishehbor, Laine Laine, Angiolillo Angiolillo, Rajagopalan Rajagopalan, Kirtane Kirtane, Piazza Piazza, Lip Lip, Mehran Mehran, Krumholz Krumholz, Ridker Ridker, Sadeghipour Sadeghipour,
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