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

Study acronym: COATED-AIR
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 19, 2025 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Secondary endpoints: details revised at 3 of 13 entries
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06541691
Lead Sponsor Rajaie Cardiovascular Medical and Research Center
Collaborators: Brigham and Women's Hospital
Conditions
(from sponsor)		 Atherosclerotic Cardiovascular Disease, Coronary Artery Disease, Ischemic Heart Disease, Ischemic Stroke, Peripheral Arterial Disease, Carotid Artery Stenosis, Carotid Atherosclerosis
Related terms Atherosclerosis, Carotid Artery Diseases, Carotid Stenosis, Cerebral Hemorrhage, Coronary Artery Disease, Duodenal Ulcer, Dyspepsia, Gastrointestinal Hemorrhage, Hemorrhage, Ischemic Stroke, Myocardial Infarction, Myocardial Ischemia, Peptic Ulcer, Peripheral Arterial Disease, Plaque, Atherosclerotic, Stomach Ulcer
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov