Comparing Enteric-Coated and Plain Low-Dose Aspirin with a Strategy to Reduce Air Pollution Effects in Patients with Atherosclerotic Cardiovascular Disease

What this Trial Is About

Researchers are evaluating the effects of two types of low-dose aspirinenteric-coated and plain formulationson patients with atherosclerotic cardiovascular diseases ASCVD. They are also studying a hybrid strategy aimed at reducing the harmful impact of air pollution on cardiovascular health. This study uses a randomized controlled trial with a 2x2 factorial design to compare these interventions and assess their clinical efficacy and safety. Participants will be assigned to receive either 81 mg enteric-coated aspirin or plain aspirin daily in a double-blind manner. Separately, they will be randomized to either a hybrid air pollution mitigation strategy, which includes educational materials, text message alerts on polluted days, recommendations to stay indoors or wear KN-95 masks when outside, and advice to consume citrus fruits, or to usual care without these interventions. The trial is conducted across multiple centers with concealed allocation and blinded outcome assessment. During the study, participants will be monitored for up to 30 months for major cardiovascular events such as ischemic stroke, myocardial infarction, acute limb events, and cardiovascular death. Researchers will collect data on these outcomes as well as bleeding events and hospitalizations. Participants will receive regular follow-ups, and all events will be reviewed by a blinded clinical events committee. The results aim to guide treatment and preventive strategies for people with ASCVD.

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