Comparing enteric-coated and plain aspirin to reduce heart disease risks from air pollution

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.