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

Recruiting now · Not applicable

Conditions studied: Atherosclerotic Cardiovascular Disease, Coronary Artery Disease, Ischemic Heart Disease, Ischemic Stroke, Peripheral Arterial Disease, Carotid Artery Stenosis, Carotid Atherosclerosis

In brief

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.

Key facts

Study ID

NCT06541691

Run by

Rajaie Cardiovascular Medical and Research Center

People needed

3000

Starts

2024-03-06

Expected to finish

2027-03-30

Last updated by the study team

2025-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (≥18 years) with documented ASCVD defined as at least one of the following:
• Coronary artery disease (CAD):
• Previous or recent documented type I myocardial infarction *(if not specified, will be assumed as type I)
• History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)
• History of obstructive CAD (>50% stenosis) documented by coronary computed tomography (CT) or conventional angiography
• Peripheral arterial disease (PAD):
• Previous or recent acute ischemic limb event (>7 days prior)
• History of previous endovascular/surgical lower or upper extremities revascularization for an atherosclerotic cause
• History of ulcer or lower extremities amputation due to ASCVD.
• Carotid arterial diseases:
• History of previous endovascular/surgical carotid artery revascularization for atherosclerotic causes
• History of > 50% carotid artery stenosis based on documented imaging tests (Duplex US, CT angiography, magnetic resonance angiography, or conventional angiography)
• Ischemic stroke:
• 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

You may not qualify if…

• 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 is running

• Rajaie Cardiovascular Medical and Research Center — Tehran, Tehran Province, Iran (enrolling)

Full record on ClinicalTrials.gov

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