Aortic stenosis and underwent transfemoral TAVR
Conditions
Interventions
Aspirin group:Take 75-100 mg of aspirin orally once a day for one year
Indobufen group:Take indolebuprofen 100 mg orally twice a day for one consecutive year
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 89 Years
Inclusion criteria
Inclusion criteria: 1.Age>=18 years; 2.Patients who have successfully undergone transfemoral transcatheter aortic valve replacement (TAVR); 3.Provision of written informed consent by the patient; 4.Patients are expected to be available for complete follow-up, with good compliance and willingness to adhere to the study requirements.
Exclusion criteria
Exclusion criteria: 1.Age>=90 years; 2.Patients requiring long-term oral or injectable anticoagulation therapy (e.g., with clear indications for anticoagulation such as atrial fibrillation, mechanical heart valves, deep vein thrombosis, etc.); 3.Patients allergic to or intolerant of indobufen or aspirin; 4.History of ischemic stroke or transient ischemic attack (TIA) within the past 6 months; 5.Left ventricular ejection fraction (LVEF) 70 mmHg from the postoperative period to discharge; 6.Severe renal or hepatic insufficiency (severe hepatic insufficiency defined as alanine aminotransferase [ALT] >3 times the upper limit of normal [ULN] or aspartate aminotransferase [AST] >2 times ULN; severe renal insufficiency defined as serum creatinine >2 times ULN or requiring dialysis); 7.Thrombocytopenia (platelet count <50,000/µL); 8.Patients requiring dual antiplatelet therapy (DAPT) that cannot be discontinued; 9.Planned other surgeries or major interventions (e.g., coronary artery bypass grafting, other valve surgeries, etc.); 10.Life expectancy <1 year; 11.Psychiatric illness or cognitive impairment that prevents understanding of the study content and procedures; 12.Pregnancy or lactation; 13.Participation in another clinical trial (e.g., drug or device study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New bleeding events within 1 year after TAVR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ischemic event composite endpoint (including cardiovascular death, myocardial infarction, ischemic stroke, TIA, clinical valve thrombosis, peripheral arterial embolism, and intracardiac thrombosis);Net clinical benefit composite endpoint (including cardiovascular death, myocardial infarction, ischemic stroke, TIA, clinical valve thrombosis, peripheral arterial embolism, intracardiac thrombosis, or new bleeding); | — |
Countries
China
Contacts
Public ContactZhou Hao
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed