Actively Recruiting
Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease
Led by Rajaie Cardiovascular Medical and Research Center · Updated on 2025-03-19
3000
Participants Needed
1
Research Sites
159 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
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.
CONDITIONS
Official 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...
- Adults aged 18 years or older with documented atherosclerotic cardiovascular disease (ASCVD) including:
- Coronary artery disease (previous or recent type I myocardial infarction, coronary revascularization, or obstructive CAD >50% stenosis)
- Peripheral arterial disease (previous acute ischemic limb event >7 days prior, previous revascularization, or ulcer/amputation due to ASCVD)
- Carotid arterial disease (previous carotid artery revascularization or >50% carotid artery stenosis)
- Ischemic stroke history not related to atrial fibrillation, endocarditis, or systemic hypotension, treated with low-dose aspirin
- Living in Tehran province
- Able and willing to provide written informed consent
You will not qualify if you...
- Within 72 days of acute or unstable cardiovascular events or within 72 hours of revascularization
- Receiving triple antithrombotic therapy
- History of upper gastrointestinal bleeding in past 30 days
- History of intracranial hemorrhage in past 30 days
- End-stage kidney disease with creatinine clearance less than 15 mL/min or on dialysis
- Known serious comorbidities with life expectancy under one year
- Conditions making participation or follow-up unsuitable (e.g., illiteracy)
- Not planned to use aspirin as part of treatment
- Unable to receive or read text messages or phone calls on personal or caregiver's mobile phone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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