NCT06541691 Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease
| NCT ID | NCT06541691 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rajaie Cardiovascular Medical and Research Center |
| Condition | Atherosclerotic Cardiovascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2024-03-06 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,000 participants in total. It began in 2024-03-06 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Parham Sadeghipour, M.D
PRINCIPAL INVESTIGATOR
Rajaie Cardiovascular Medical and Research Center
Frequently Asked Questions
Who can join the NCT06541691 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atherosclerotic Cardiovascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06541691 currently recruiting?
Yes, NCT06541691 is actively recruiting participants. Contact the research team at psadeghipour@hotmail.com for enrollment information.
Where is the NCT06541691 trial being conducted?
This trial is being conducted at Tehran, Iran.
Who is sponsoring the NCT06541691 clinical trial?
NCT06541691 is sponsored by Rajaie Cardiovascular Medical and Research Center. The principal investigator is Parham Sadeghipour, M.D at Rajaie Cardiovascular Medical and Research Center. The trial plans to enroll 3,000 participants.