Status:
RECRUITING
Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease
Lead Sponsor:
Rajaie Cardiovascular Medical and Research Center
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Atherosclerotic Cardiovascular Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 p...
Detailed Description
\- Background: Aspirin is a key treatment option of patients with atherosclerotic cardiovascular disease (ASCVD). The enteric coating has emerged as a potential solution to minimize the exposure of th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2027
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06541691
Start Date
March 6 2024
End Date
March 30 2027
Last Update
March 19 2025
Active Locations (1)
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1
Rajaie Cardiovascular Medical and Research Center
Tehran, Tehran Province, Iran, 1995614331