Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease

Although both enteric-coated and plain formulations of aspirin are being used commonly, there are no high-quality comparisons between these formulations with respect to clinical efficacy outcomes in patients with atherosclerotic cardiovascular diseases (ASCVD). Air pollution is also a major contributor to the excess risk of cardiovascular events in many regions of the world. However, little is known about the effect of individual-level mitigation strategies against air pollution in reducing cardiovascular outcomes. The purpose of the first randomization is to compare the efficacy and safety of enteric-coated versus plain low-dose (81 mg) aspirin formulations in a double-blind fashion. The second randomization compares a multifaceted intervention including one-page educational flashcard, cell phone text messages alerting participants on polluted days, recommending them to stay indoors or wear KN-95 facemasks provided by the study team in case of necessary outdoor activity, and recommendation to consume citrus fruits on polluted days versus usual care. Both randomization are powered for clinical outcomes and the results will inform practice.

NCT Number	NCT06541691
Lead Sponsor	Rajaie Cardiovascular Medical and Research Center Collaborators: Brigham and Women's Hospital
Conditions	Atherosclerotic Cardiovascular Disease, Coronary Artery Disease, Ischemic Heart Disease, Ischemic Stroke, Peripheral Arterial Disease, Carotid Artery Stenosis, Carotid Atherosclerosis
Enrollment	3,000 participants
Start Date	2024-03-06
Primary Completion	2026-03-30 (estimated)
Study Completion	2027-03-30 (estimated)
Updated on ClinicalTrials.gov	2025-03-19