A multicenter randomized controlled study to evaluate Cessation of antithRombotic thErApy at 1 year in TAVR patiEnts—the CREATE study
Not Applicable
Recruiting
- Conditions
- Aortic stenosis
- Registration Number
- ChiCTR2400087454
- Lead Sponsor
- Beijing Anzhen Hospital Affiliated to Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients age >= 18 years old;<br>2. Patients diagnosed with severe aortic stenosis who underwent successful TAVR for more than 12 months;<br>3. Patients did not occur myocardial infarction, stroke, or rehospitalization due to bioprosthetic valve disfunction within 12 months after TAVR;<br>4. Patients agree to follow the study plan to complete the follow-up;<br>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
- Patients with indications for long-term anticoagulation (e.g., pulmonary embolism, deep vein thrombosis, history or new-onset of atrial fibrillation, etc.);<br>2. Patients with indications for long-term antiplatelet therapy (e.g., ischemic stroke, coronary heart disease, prior PCI/CABG/peripheral arterial surgery, etc.);<br>3. Patients with other valvular heart disease requiring intervention, such as mitral valve stenosis;<br>4. Imaging findings arterial lumen stenosis > 50%;<br>5. Patients with inherited or acquired defects such as anticoagulant protein, coagulation factor, fibrinolysin, or high thromboembolic tendency due to acquired risk factors;<br>6. Patients are diagnosed with bioprothestic valve failure of aortic valve;<br>7. Patient was diagnosed with intermuscular venous thrombosis;<br>8. Patients have uncured cancer;<br>9. Patients have active bleeding;<br>10. Patients with life expectancy < 1 year;<br>11. Researchers believe that patients not suitable to participate in clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VARC-3 definition bleeding events;VARC-3 definition ischemic events, including cardiac death, myocardiac infarction and ischemic stroke;
- Secondary Outcome Measures
Name Time Method 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;