Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
NCT ID:
NCT06261606
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
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 cause
2. History of \> 50% carotid artery stenosis based on documented imaging tests (Duplex ultrasonography, CT angiography, magnetic resonance angiography, or conventional angiography)
* Ischemic stroke:
1. History of recent or previous documented ischemic stroke not due to systemic hypoperfusion/hypotension being treated with low-dose aspirin
* Willing to participate and able to provide written informed consent
Exclusion Criteria:
* Being within 7 days of acute/unstable ASCVD events (acute myocardial infarction, acute limb event, and acute ischemic stroke) or receiving triple antithrombotic therapy
* Active bleeding
* 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 aspirin sensitivity without prior successful desensitization
* 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
* Vascular disease known exclusively to be from causes other than atherosclerosis (spontaneous coronary or peripheral dissection (fibromuscular dysplasia, segmental arterial mediolysis) or vasculitis such as Takayasu arteritis, Buerger's disease (i.e., thromboangiitis obliterans), and Churg Strauss syndrome
* Inherited or acquired severe coagulopathies including hemophilia and decompensated liver cirrhosis
* Any other unexpected/unwarranted conditions that make the participants unsuitable for recruitment or follow-up
* Known allergy to KN-95 or other masks, or citrus fruits
* Any facial dysmorphia that makes the patient unable or unwilling to wear a face mask
* Any medical condition necessitating unblinded facemask use for outdoor activities at the discretion of the treating clinician, or based on patient preference
* Inability to receive/read text messages/phone calls by personal mobile phone
* Unwillingness to participate, such as hesitation to wear a mask, if randomized
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06261606
Study Brief:
Protocol Section:
NCT06261606