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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRajaie Cardiovascular Medical and Research Center

About this trial

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.

Eligibility criteria

Qualifiers

Previous or recent documented type I myocardial infarction *(if not specified, will be assumed as type I)

History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)

History of obstructive CAD (>50% stenosis) documented by coronary computed tomography (CT) or conventional angiography

Previous or recent acute ischemic limb event (>7 days prior)

Disqualifiers

Being within 72 days of acute/unstable atherosclerotic cardiovascular events (acute myocardial infarction, acute limb event, and acute ischemic stroke), or within 72 hours of revascularization.

Patients receiving triple antithrombotic therapy

History of upper gastrointestinal bleeding within the past 30 days

History of intracranial hemorrhage within the past 30 days

Trial design

Treatments tested in this trial

  • Enteric-coated aspirin
  • Plain aspirin
  • Hybrid strategy

Treatment groups

3,000 Participants
are divided into 4 treatment groups

Sponsors and collaborators