Status:
COMPLETED
Effects of Rivaroxaban on Vascular FMD in Patients With Stable Atherosclerotic Vascular Diseases
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Bayer
Conditions:
Atherosclerosis, Coronary
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
The specific mechanistic benefit of rivaroxaban versus other FXa inhibitors on atherothrombotic events remain unclear. Therefore plan to initiate a prospective, randomized study to investigate the eff...
Detailed Description
Factor Xa (FXa) and thrombin are well-known components of the coagulation cascade and other biological and pathophysiological processes that are linked to atherothrombotic as well as thromboembolic ev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06986369
Start Date
May 4 2021
End Date
March 1 2024
Last Update
May 23 2025
Active Locations (1)
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1
Queen Mary Hospital, the University of Hong Kong
Hong Kong, China