Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Follow-up | Baseline (visit 1) | 1 month (visit 2, ± 7 days) | 6 months (visit 3, ± 7 days) |
---|---|---|---|
Inclusion/exclusion criteria | X | ||
Physical examination | X | ||
Vital signs | X | ||
ICF | X | ||
Contact information | X | ||
Demographic data | X | ||
Previous history | X | ||
Admitting diagnosis | X | ||
Subject guidance | X | ||
Drug therapy | X | X | X |
hs-CRP | X | X | X |
Imaging examination | X | X | |
MACCE | X | X | |
Other laboratory tests | X | X | X |
Bleeding events (BARC) | X | X | X |
Liver function | X | X | X |
Renal function | X | X | X |
Subject compliance | X | X |
Inclusion and exclusion criteria {10}
Inclusion criteria |
---|
1. 18–85 years old |
2. AAA diagnosed by CTA; the maximal diameter of aneurysm is 30–50 mm |
3. Serum hs-CRP ≥ 2 mg/L |
4. Written informed consent |
Exclusion criteria |
---|
1. ACS (unstable angina and acute myocardial infarction) |
2. Dual antiplatelet therapy for stable CHD less than 6 months after PCI or ACS less than 1 year after PCI |
3. Acute congestive heart failure or left ventricular ejection fraction ≤ 40% |
4. Suffered from infectious diseases within 2 months before screening and infection has not been controlled more than 1 month |
5. Active hepatitis, the elevation of alanine aminotransferase (ALT) value > 5 × the upper limit of normal |
6. Severe renal failure (CrCl < 30 ml/min) |
7. Life expectancy is less than 1 year |
8. Any situation may interfere with the research process, such as dementia, paralysis, alcoholism, etc |
9. Pregnancy or women during the lactation period |
10. Suffered from hereditary connective tissue disease, such as Marfan’s syndrome, etc |
11. Known allergies or intolerance to aspirin or rivaroxaban |
12. AAA tends to rupture or has ruptured, and abdominal pain aggravates |
13. Major surgery within 1 month |
14. Active stage of severe peptic ulcer or previous bleeding events (including retinal or vitreous hemorrhage, urinary tract hemorrhage, etc.) within 6 months |
15. Have participated in other ongoing clinical studies |
16. Refuse to provide a written informed consent |
17. Other unsuitable conditions adjudicated by investigators |