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:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT06986369
Eligibility Criteria:
Inclusion Criteria:
patients must fulfill the following criteria.
* Willing and able to provide written informed consent
* CAD and/or PAD
* Subjects with CAD must also meet at least 1 of the following criteria:
Age 65 years or older, or Age younger than 65 years and documented atherosclerosis or revascularization involving at least 2 vascular beds or at least 2 additional risk factors:
* Current smoker (within 1 year of randomization)
* Diabetes mellitus
* Renal dysfunction with estimated glomerular filtration rate \< 60 mL/min
* Heart failure
* Non-lacunar ischemic stroke \>/= 1 month ago
Exclusion Criteria:
* High risk of bleeding
* Stroke within 1 month or any history of hemorrhagic or lacunar stroke
* Severe heart failure with known ejection fraction \< 30% or New York Heart Association class III or IV symptoms
* Estimated glomerular filtration rate \< 15 mL/min
* Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
* Known non-cardiovascular disease that is associated with poor prognosis (eg, metastatic cancer) or that increases the risk of an adverse reaction to study interventions
* History of hypersensitivity or known contraindication for rivaroxaban, aspirin, pantoprazole, or excipients, if applicable
* Systemic treatment with strong inhibitors of CYP3A4 as well as p-glycoprotein (eg, systemic azole antimycotics, such as ketoconazole, and HIV-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4 (ie, rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine)
* Any known hepatic disease associated with coagulopathy
* Subjects who are pregnant, breastfeeding, or are of childbearing potential, and sexually active and not practicing an effective method of birth control (eg, surgically sterile, prescription oral contraceptives, contraceptive injections, intrauterine device, double- barrier method, contraceptive patch, male partner sterilization)
* Previous assignment to treatment during this study
* Concomitant participation in another study with investigational drug
* Known contraindication to any study-related procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06986369
Study Brief:
Protocol Section:
NCT06986369