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New treatment option for Atherosclerotic Cardiovascular Disease
Official title Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease
ClinicalTrials.gov ID: NCT06541691
What this study is testing
What is Enteric-coated aspirin?
Enteric-coated aspirin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for atherosclerotic cardiovascular disease.
Also referred to as Low dose of enteric-coated aspirin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join if
- Being within 72 days of acute/unstable atherosclerotic cardiovascular events (acute myocardial infarction, acute limb event, and acute ischemic...
- 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...
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tehran, Tehran Province, Iran
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tehran, Tehran Province, Iran. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.