Aortic stenosis
Conditions
Interventions
Single antiplatelet group:More than 1 year after TAVR, patients who did not have indications for antithrombotic therapy were randomly assigned to continuation group of antiplatelet therapy
No antiplatelet group:More than 1 year after TAVR, patients who did not have indications for antithrombotic therapy were randomly assigned to cessation group of antiplatelet therapy
Sponsors
Beijing Anzhen Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients age >= 18 years old; 2. Patients diagnosed with severe aortic stenosis who underwent successful TAVR for more than 12 months; 3. Patients did not occur myocardial infarction, stroke, or rehospitalization due to bioprosthetic valve disfunction within 12 months after TAVR; 4. Patients agree to follow the study plan to complete the follow-up; 5. Patients understand the purpose of the study, voluntarily participated in the study, and signed informed consent forms that were reviewed and approved by the ethics committee.
Exclusion criteria
Exclusion criteria: 1. Patients with indications for long-term anticoagulation (e.g., pulmonary embolism, deep vein thrombosis, history or new-onset of atrial fibrillation, etc.); 2. Patients with indications for long-term antiplatelet therapy (e.g., ischemic stroke, coronary heart disease, prior PCI/CABG/peripheral arterial surgery, etc.); 3. Patients with other valvular heart disease requiring intervention, such as mitral valve stenosis; 4. Imaging findings arterial lumen stenosis > 50%; 5. Patients with inherited or acquired defects such as anticoagulant protein, coagulation factor, fibrinolysin, or high thromboembolic tendency due to acquired risk factors; 6. Patients are diagnosed with bioprothestic valve failure of aortic valve; 7. Patient was diagnosed with intermuscular venous thrombosis; 8. Patients have uncured cancer; 9. Patients have active bleeding; 10. Patients with life expectancy < 1 year; 11. Researchers believe that patients not suitable to participate in clinical trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| All-cause death;Cardiovascular death;Miocardial infarction;Stroke;BARC definition type 1/2/3/5 bleeding events;Composite outcomes events of all-cause death, first occurrence of first myocardial infarction, ischemic stroke, life-threatening bleeding/disabling bleeding/major bleeding, and all bleeding events; | — |
Primary
| Measure | Time frame |
|---|---|
| VARC-3 definition bleeding events;VARC-3 definition ischemic events, including cardiac death, myocardiac infarction and ischemic stroke; | — |
Countries
China
Contacts
Public ContactGuangyuan Song
Beijing Anzhen Hospital Affiliated to Capital Medical University, Beijing, China
Outcome results
None listed