Comparing enteric-coated and plain aspirin to reduce heart disease risks from air pollution
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
This study is testing whether enteric-coated or plain low-dose aspirin can better help people with heart disease reduce their risks from air pollution, along with providing tips to stay healthy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rajaie Cardiovascular Medical and Research Center Academic / other |
| Locations | 1 site (Tehran, Tehran Province) |
| Trial ID | NCT06541691 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of enteric-coated versus plain low-dose aspirin in patients with atherosclerotic cardiovascular disease (ASCVD). It will also evaluate a hybrid strategy that includes educational materials and alerts to help patients mitigate the adverse effects of air pollution on their cardiovascular health. Participants will be randomly assigned to receive either formulation of aspirin and will be monitored for cardiovascular outcomes over time. The study seeks to provide high-quality evidence on the best aspirin formulation and effective strategies to reduce pollution-related health risks.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with documented atherosclerotic cardiovascular disease.
Not a fit: Patients without a history of atherosclerotic cardiovascular disease or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with ASCVD, enhancing their cardiovascular health and reducing pollution-related risks.
How similar studies have performed: While studies have explored the effects of aspirin in cardiovascular disease, this specific comparison of formulations and the hybrid strategy against air pollution is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Adult patients (≥18 years) with documented ASCVD defined as at least one of the following:
* Coronary artery disease (CAD):
1. Previous or recent documented type I myocardial infarction \*(if not specified, will be assumed as type I)
2. History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)
3. History of obstructive CAD (\>50% stenosis) documented by coronary computed tomography (CT) or conventional angiography
* Peripheral arterial disease (PAD):
1. Previous or recent acute ischemic limb event (\>7 days prior)
2. History of previous endovascular/surgical lower or upper extremities revascularization for an atherosclerotic cause
3. History of ulcer or lower extremities amputation due to ASCVD.
* Carotid arterial diseases:
1. History of previous endovascular/surgical carotid artery revascularization for atherosclerotic causes
2. History of \> 50% carotid artery stenosis based on documented imaging tests (Duplex US, CT angiography, magnetic resonance angiography, or conventional angiography)
* Ischemic stroke:
1. History of recent or previous documented ischemic stroke not due to atrial fibrillation, endocarditis, or systemic hypoperfusion/hypotension, being treated with low-dose aspirin
* Inhabitant of Tehran province
* Willing to participate and able to provide written informed consent
Exclusion Criteria:
* 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
* End-stage kidney disease with estimated creatinine clearance \< 15 mL/min, or undergoing hemodialysis or peritoneal dialysis
* Known comorbidities associated with poor prognosis (e.g., metastatic cancer) in conjunction with an estimated life expectancy of less than one year according to the treating clinician
* Any other conditions that make the participants unsuitable for recruitment or follow-up (e.g., illiteracy)
* Not having aspirin as part of the planned durable treatment regimen
* Inability to receive/read text messages/phone calls by personal mobile phone (or that of a caregiver who lives with the patient and is willing to relay messages)
* The full list of exclusion criteria is provided in the study protocol
Where this trial is running
Tehran, Tehran Province
- Rajaie Cardiovascular Medical and Research Center — Tehran, Tehran Province, Iran (Recruiting)
Study contacts
- Principal investigator: Parham Sadeghipour, M.D — Rajaie Cardiovascular Medical and Research Center
- Study coordinator: Parham Sadeghipour, MD
- Email: psadeghipour@hotmail.com
- Phone: +982123921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.