Actively Recruiting
Coated or Chewable Aspirin in Patients with Established Atherosclerotic Disease and a Hybrid Strategy to Mitigate the Adverse Effects of Air Pollution: the COATED-AIR Randomized Clinical Trial
Led by Rajaie Cardiovascular Medical and Research Center · Updated on 2025-03-19
3000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
Rajaie Cardiovascular Medical and Research Center
Lead Sponsor
B
Brigham and Women's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two types of low-dose aspirin—enteric-coated and plain formulations—on 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.
CONDITIONS
Brief Title
Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older with documented atherosclerotic cardiovascular disease (ASCVD)
- ASCVD includes coronary artery disease (previous myocardial infarction, history of coronary revascularization, or obstructive CAD >50% stenosis)
- Peripheral arterial disease (history of acute ischemic limb event, revascularization, ulcer, or amputation due to ASCVD)
- Carotid artery disease (history of carotid revascularization or >50% carotid stenosis by imaging)
- History of ischemic stroke not caused by atrial fibrillation, endocarditis, or systemic hypotension, treated with low-dose aspirin
- Resident of Tehran province
- Willing and able to provide written informed consent
You will not qualify if you...
- Within 72 days of an acute or unstable cardiovascular event (heart attack, limb event, or ischemic stroke) or within 72 hours of revascularization
- Receiving triple antithrombotic therapy
- History of upper gastrointestinal bleeding in the past 30 days
- History of intracranial hemorrhage in the past 30 days
- End-stage kidney disease with creatinine clearance less than 15 mL/min or on dialysis
- Serious comorbid conditions with life expectancy under one year
- Any condition making participation or follow-up unsuitable (e.g., illiteracy)
- Not using aspirin as part of ongoing treatment
- Inability to receive or read text messages or phone calls on a personal mobile phone or via a caregiver living with the participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 months
Participants take either enteric-coated aspirin or plain aspirin once daily. Some participants also follow a hybrid strategy composed of educational materials and alerts to mitigate the cardiovascular effects of air pollution by minimizing outdoor exposure, using face masks, and consuming citrus fruits on highly polluted days.
Regular visits as per study schedule
Trial Site Locations
Total: 1 location
1
Rajaie Cardiovascular Medical and Research Center
Tehran, Tehran Province, Iran, 1995614331
Actively Recruiting
Research Team
P
Parham Sadeghipour, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
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