Femoropopliteal Artery Arteriosclerosis obliterans
Conditions
Interventions
Trial group :Aspirin 100mg+rivaroxaban 10mg orally 1/day
Control group:Aspirin 100 mg + Clopidogrel 75 mg orally 1/day
Sponsors
The First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age >=50 years and 24 months. 6. For patients with aortoiliac artery disease, recanalization was achieved with less than 30% residual stenosis after endovascular reconstruction.
Exclusion criteria
Exclusion criteria: 1. History of active bleeding or related lesions/diseases within the 3 months prior to enrollment, including intracranial hemorrhage, gastrointestinal ulcer bleeding, malignancies with high bleeding risk, current or recent brain or spinal cord injuries, esophageal and gastric varices, major spinal or intracranial vascular abnormalities, etc. 2. Fecal occult blood positive patients. 3. Patients with more than 3 times of repeated interventional operations on the affected limb. 4. Patients who had undergone arterial bypass in the affected limb. 5. Burger's disease, atrial fibrillation, inflammatory lesions of the lower extremities. Diagnosed with acute coronary syndrome within 30 days prior to enrollment. 6. EGFR (estimated glomerular filtration rate) less than 60 mL/min/1.73 m², or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than 3 times the upper limit of normal. 7. Patients known to be allergic to heparin, aspirin, rivaroxaban, clopidogrel, or other antiplatelet and anticoagulant drugs, contrast agents, etc., as well as patients with resistance to aspirin or clopidogrel. 8. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months. 9. Pregnant and lactating women. 10. Patients unable or unwilling to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically driven target lesion revascularization (CD-TLR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary patency rate;Major adverse events;Bleeding events;EuroQol five-dimension health scale and Vascular Quality of Life Questionnaire; | — |
Countries
China
Contacts
Public ContactLiangxi Yuan
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed