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| Name | Class |
|---|---|
| Suzhou Jiecheng Medical Technology Co., Ltd. | UNKNOWN |
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This multicenter randomized controlled trial evaluates antithrombotic strategies post-TAVR in severe aortic regurgitation patients without long-term anticoagulation. Patients are randomized 1:1 to aspirin 75-100 mg daily for 12 months versus warfarin (INR 2-3) for 6 months followed by aspirin for 6 months. Primary hypothesis: aspirin is superior for bleeding and non-inferior for death/thrombosis. Primary endpoint is a composite of death, stroke, thrombosis, MI, embolism, and major bleeding at 1 year. Sample size: 1172. Follow-up: 30 days, 6 months, 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin Monotherapy | Experimental | Aspirin 75-100 mg orally once daily for 12 months |
|
| Standard Therapy | Active Comparator | Warfarin (INR 2-3) for 6 months, followed by Aspirin 75-100 mg once daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Aspirin 75-100 mg orally once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Non-hierarchical Composite Endpoint | The primary endpoint is a non-hierarchical composite endpoint including all-cause death, stroke, prosthetic valve thrombosis, intracardiac thrombosis, myocardial infarction, deep vein thrombosis or pulmonary embolism, systemic embolism, and life-threatening, disabling, or major bleeding (VARC-3 definition). | 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Composite Endpoint of All-Cause Death, Ischemic Stroke, Valve/Intracardiac Thrombosis, and Myocardial Infarction. | The first key secondary endpoint is composite of all-cause death, ischemic stroke, valve/intracardiac thrombosis, and myocardial infarction. | 12 months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lai Wei, MD | Contact | +86-021-64041990 | Wei.lai@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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Experimental Group: Aspirin 75-100 mg qd × 12 months Control (Standard) Group:Warfarin (INR 2-3) × 6 months, then aspirin 75-100 mg qd × 6 months
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| Warfarin |
| Drug |
Warfarin orally with dose adjusted to maintain INR 2-3 |
|
| Number of Participants Who Experienced Composite of Life-threatening, Disabling, or Major Bleeding (based on VARC-3 criteria Type 2-4) |
Life-threatening or disabling bleeding Fatal bleeding OR Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome OR Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery OR Overt source of bleeding with drop in haemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 unitsa Major bleeding Overt bleeding either associated with a drop in the haemoglobin level of at least 3.0 g/dL or requiring transfusion of two or three units of whole blood/RBC AND Does not meet criteria of life-threatening or disabling bleeding |
| 12 months post-procedure |
| Number of Participants Who Experience Composite of Cardiovascular Death, Major Bleeding, Stroke, and Myocardial Infarction | 12 months post-procedure |
| Number of Participants Who Experience Clinical Efficacy Composite Endpoint | Composite endpoint requiring all of the following: freedom from all-cause death; freedom from all stroke; no hospitalization for valve-related or procedure-related reasons; and KCCQ overall score ≥45 with no more than a 10-point decrease from baseline. | 12 months post-procedure |
| Number of Participants Who Experienced All-Cause Death | 12 months post-procedure |
| Number of Participants Who Experience Clinically Significant Prosthetic Valve Thrombosis (VARC-3) | Based on VARC-3 criteria, clinically significant prosthetic valve thrombosis defined as clinical. sequelae of a thromboembolic event (e.g. stroke, TIA, retinal occlusion, other evidence of systemic thromboembolism) or worsening valve stenosis/ regurgitation (e.g. signs of heart failure, syncope) and Haemodynamic valve deterioration Stage 2 or 3 or Confirmatory imaging (CT evidence of HALT or TEE findings) In the absence of clinical sequelae, both Haemodynamic valve deterioration Stage 3 and Confirmatory imaging (CT evidence of HALT or TEE findings) | At 6 months and 12 months post-procedure |
| Number of Participants Who Experience Bioprosthetic Valve Deterioration Stage 3 by Echocardiography (VARC-3) | Bioprosthetic Valve Failure Stage 3 defined as increase in mean transvalvular gradient ≥20 mmHg resulting in mean gradient ≥30 mmHg with concomitant decrease in EOA ≥0.6 cm2 or ≥50% and/or decrease in Doppler velocity index ≥0.2 or ≥40% compared with echocardiographic assessment performed 1-3 months post-procedure, OR new occurrence, or increase of ≥2grades, of intraprosthetic AR resulting in severe AR | 12 months post-procedure |
| Number of Participants Who Experience Hypo-Attenuated Leaflet Thickening (HALT) by CT | 12 months post-procedure |
| Number of Participants Who Experienced Non-Procedure-Related Life-Threatening or Disabling Bleeding (VARC-3) | At 30 days and 12 months post-procedure |
| Number of Participants Who Experienced Major Bleeding | Based on VARC 2 criteria | At 30 days and 12 months post-procedure |
| Number of Participants Who Experienced Minor Bleeding | Based on VARC 2 criteria | At 30 days and 12 months post-procedure |
| Number of Participants Who Experienced Aortic Valve Re-Intervention | 12 months post-procedure |
| Number of Participants Who Experienced Heart Failure Re-Hospitalization | 12 months post-procedure |
| Number of Participants Who Experienced Infective Endocarditis | Infective Endocarditis defined as: Meeting at least one of the following criteria: Fulfills the Duke criteria for endocarditis; Intraoperative evidence of an abscess, pus, or vegetation secondary to infection, confirmed by histology or microbiology; Autopsy evidence of an abscess, pus, or vegetation. | 12 months post-procedure |
| Number of Participants Who Experienced Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | MACCE including cardiac death, aortic valve reintervention, stroke, myocardial infarction, heart failure readmission and life-threatening, disabling, or major bleeding. | At 30 days and 12 months post-procedure |
| Number of Participants Who Experienced NYHA Class Improvement | At 30 days and 12 months post-procedure |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |