NCT06986369CompletedPhase 4
Effects of Rivaroxaban on Vascular FMD in Patients With Stable Atherosclerotic Vascular Diseases
Effects of Rivaroxaban on Vascular Endothelial Function and Circulating Endothelial Progenitor Cells in Patients With Stable Atherosclerotic Vascular Diseases
Source: ClinicalTrials.gov · Last updated 23 May 2025
Brief summary (registry, in English)
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 effect of rivaroxaban and aspirin versus aspirin alone on changes of number circulating endothelial cells and endothelial function, and alteration in systemic inflammation, platelet and coagulation activation in patients with stable atherosclerotic vascular diseases. The working hypothesis of this trial is that rivaroxaban and aspirin is superior to aspirin alone improvement in the number of circulating endothelial cells and endothelial function, assessed by flow-mediated vasodilatation, and reduction in systemic inflammation, platelet and coagulation activation in patients with stable atherosclerotic vascular diseases at 3 months follow-up.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 7 Mar 2024
- Start date
- 4 May 2021
- Primary completion date
- 28 Aug 2023
- Lead sponsor
- The University of Hong Kong
- Diseases
- Coronary artery disease
- NCT number
- NCT06986369
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 140
- From 4 May 2021 to the primary completion date, 28 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
- 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)
- Previous assignment to treatment during this study
- Concomitant participation in another study with investigational drug
Other illness
- High risk of bleeding
- Stroke within 1 month or any history of hemorrhagic or lacunar stroke
- 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
- Any known hepatic disease associated with coagulopathy
Lab values
- Severe heart failure with known ejection fraction \< 30% or New York Heart Association class III or IV symptoms
Other
- Estimated glomerular filtration rate \< 15 mL/min
- 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)
- Known contraindication to any study-related procedures
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Mary Hospital, the University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.