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

Launched by RAJAIE CARDIOVASCULAR MEDICAL AND RESEARCH CENTER · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of two types of low-dose aspirin (enteric-coated and plain) in patients with atherosclerotic cardiovascular diseases, which include conditions like coronary artery disease and ischemic stroke. Additionally, the study aims to see if a special support program—like educational materials and alerts about air pollution—can help reduce health risks for these patients when pollution levels are high. The trial is currently recruiting participants aged 18 and older who live in Tehran and have documented cardiovascular disease.

If you qualify for the study, you will be randomly assigned to receive either enteric-coated or plain aspirin, and you may also be part of the support program or receive standard care. Throughout the trial, you'll have regular check-ins to monitor your health and how well the treatments work. It's important to note that certain health conditions could make you ineligible, such as recent serious cardiovascular events or specific kidney issues. If you're interested, you’ll need to provide written consent and be able to receive text messages about your participation.

Gender

ALL

Eligibility 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