Aortic Regurgitation DiseaseAWATARNCT07677410
Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation
A study testing Aspirin and Warfarin in people with Aortic Regurgitation Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Regurgitation Disease
- What is being tested?
- Aspirin and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,172 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2026to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Patients with severe aortic regurgitation (AR) who achieve technical success after TAVR using devices specifically indicated for AR (per VARC-3 criteria).
- Trileaflet aortic valve anatomy.
- No long-term anticoagulation indication (including but not limited to: atrial fibrillation, mechanical mitral valve prosthesis, deep vein thrombosis, pulmonary embolism, left ventricular thrombus, pulmonary hypertension, or coagulation disorders) as confirmed by the investigator.
- Signed written informed consent and willingness to comply with randomization, study procedures, and follow-up.
Who cannot join
- Need for oral anticoagulation or dual antiplatelet therapy, or need for oral or intravenous strong CYP3A inhibitors that cannot be paused during the study period.
- Active pathological bleeding, subdural hematoma, or history of intracranial hemorrhage.
- Ischemic stroke within 30 days before TAVR.
- Acute myocardial infarction within 30 days.
- Severe hepatic insufficiency (cirrhosis, hepatic decompensation).
- Severe renal insufficiency (eGFR < 30 mL/min/1.73 m²) or need for renal replacement therapy.
Show all 17Show fewer
- Stent implantation (including coronary, carotid, or peripheral arteries) within 12 months before TAVR, or planned stent implantation within 1 year after TAVR.
- Coronary artery bypass grafting (CABG) within 12 months before TAVR.
- Allergy, intolerance, or known resistance to aspirin, clopidogrel, or warfarin.
- Known coagulation disorders or bleeding diathesis (including but not limited to platelet count ≤50,000/mm³ at screening).
- Any contraindication to anticoagulation therapy.
- Prior aortic valve prosthesis (mechanical or bioprosthetic); mitral valve bioprosthesis replacement within 1 year before TAVR; or prior mitral mechanical valve replacement; or prior tricuspid valve replacement.
- Emergency TAVR with cardiogenic shock manifesting as low cardiac output, vasopressor or respiratory dependence, or mechanical hemodynamic support.
- Life expectancy <1 year (e.g., terminal malignancy).
- Participation in another investigational drug or device clinical study (patients who have completed the primary endpoint of the study and are currently in long-term follow-up are not excluded).
- Pregnancy or planned pregnancy, or use of estrogen or estrogen-like drugs (for women with suspected pregnancy, serum or urine human chorionic gonadotropin test must be negative before enrollment).
- Any other condition deemed by the investigator to be inappropriate for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Lai Wei, MD, +86-021-64041990, Wei.lai@zs-hospital.sh.cn
About this study
Official title: Prospective, Multicenter, Randomized Controlled Trial Evaluating the Safety and Efficacy of Different Antithrombotic Therapy Strategies in Patients With Severe Aortic Regurgitation Undergoing Transcatheter Aortic Valve Replacement
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.
- Conditions
- Aortic Regurgitation Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin 75-100 mg orally once daily
WarfarinDrug
Warfarin orally with dose adjusted to maintain INR 2-3
| Study group | Role | What they receive |
|---|---|---|
| Aspirin Monotherapy | Experimental | Aspirin 75-100 mg orally once daily for 12 months Receives: Drug: Aspirin |
| Standard Therapy | Active comparator | Warfarin (INR 2-3) for 6 months, followed by Aspirin 75-100 mg once daily for 6 months Receives: Drug: Aspirin; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months post-procedure
Secondary outcomes (16)
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.
Measured: 12 months post-procedure
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
Measured: 12 months post-procedure
Number of Participants Who Experience Composite of Cardiovascular Death, Major Bleeding, Stroke, and Myocardial Infarction
Measured: 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.
Measured: 12 months post-procedure
Number of Participants Who Experienced All-Cause Death
Measured: 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)
Measured: 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
Measured: 12 months post-procedure
Number of Participants Who Experience Hypo-Attenuated Leaflet Thickening (HALT) by CT
Measured: 12 months post-procedure
Number of Participants Who Experienced Non-Procedure-Related Life-Threatening or Disabling Bleeding (VARC-3)
Measured: At 30 days and 12 months post-procedure
Number of Participants Who Experienced Major Bleeding
Based on VARC 2 criteria
Measured: At 30 days and 12 months post-procedure
Number of Participants Who Experienced Minor Bleeding
Based on VARC 2 criteria
Measured: At 30 days and 12 months post-procedure
Number of Participants Who Experienced Aortic Valve Re-Intervention
Measured: 12 months post-procedure
Number of Participants Who Experienced Heart Failure Re-Hospitalization
Measured: 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.
Measured: 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.
Measured: At 30 days and 12 months post-procedure
Number of Participants Who Experienced NYHA Class Improvement
Measured: At 30 days and 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start18 Jul 2026
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Regurgitation DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Jiecheng Medical Technology Co., Ltd.
- Responsible party
- Principal investigator, Wei Lai, MD, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677410
- Sponsor's protocol ID
- KY2026134
- Acronym
- AWATAR
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Trial Evaluating the Safety and Efficacy of Different Antithrombotic Therapy Strategies in Patients With Severe Aortic Regurgitation Undergoing Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT07677410
- Acronym / sponsor ID
- AWATAR / KY2026134
- Conditions
- Aortic Regurgitation Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,172 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Suzhou Jiecheng Medical Technology Co., Ltd.
- Study start
- 18 Jul 2026 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Aspirin Monotherapy | Experimental | Drug: AspirinAspirin 75-100 mg orally once daily for 12 months |
| Standard Therapy | Active comparator | Drug: Aspirin, Drug: WarfarinWarfarin (INR 2-3) for 6 months, followed by Aspirin 75-100 mg once daily for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Patients with severe aortic regurgitation (AR) who achieve technical success after TAVR using devices specifically indicated for AR (per VARC-3 criteria).
- Trileaflet aortic valve anatomy.
- No long-term anticoagulation indication (including but not limited to: atrial fibrillation, mechanical mitral valve prosthesis, deep vein thrombosis, pulmonary embolism, left ventricular thrombus, pulmonary hypertension, or coagulation disorders) as confirmed by the investigator.
- Signed written informed consent and willingness to comply with randomization, study procedures, and follow-up.
Key exclusion criteria (17 listed)
- Need for oral anticoagulation or dual antiplatelet therapy, or need for oral or intravenous strong CYP3A inhibitors that cannot be paused during the study period.
- Active pathological bleeding, subdural hematoma, or history of intracranial hemorrhage.
- Ischemic stroke within 30 days before TAVR.
- Acute myocardial infarction within 30 days.
- Severe hepatic insufficiency (cirrhosis, hepatic decompensation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAspirin 75-100 mg orally once daily | Drug | Aspirin Monotherapy, Standard Therapy |
| WarfarinWarfarin orally with dose adjusted to maintain INR 2-3 | Drug | Standard Therapy |
Primary outcome
Number of Participants Who Experienced Non-hierarchical Composite Endpoint
Time frame: 12 months post-procedure
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).
16 secondary outcomes
Number of Participants Who Experienced Composite Endpoint of All-Cause Death, Ischemic Stroke, Valve/Intracardiac Thrombosis, and Myocardial Infarction.
Time frame: 12 months post-procedure
Number of Participants Who Experienced Composite of Life-threatening, Disabling, or Major Bleeding (based on VARC-3 criteria Type 2-4)
Time frame: 12 months post-procedure
Number of Participants Who Experience Composite of Cardiovascular Death, Major Bleeding, Stroke, and Myocardial Infarction
Time frame: 12 months post-procedure
Number of Participants Who Experience Clinical Efficacy Composite Endpoint
Time frame: 12 months post-procedure
Number of Participants Who Experienced All-Cause Death
Time frame: 12 months post-procedure
Number of Participants Who Experience Clinically Significant Prosthetic Valve Thrombosis (VARC-3)
Time frame: At 6 months and 12 months post-procedure
Number of Participants Who Experience Bioprosthetic Valve Deterioration Stage 3 by Echocardiography (VARC-3)
Time frame: 12 months post-procedure
Number of Participants Who Experience Hypo-Attenuated Leaflet Thickening (HALT) by CT
Time frame: 12 months post-procedure
Number of Participants Who Experienced Non-Procedure-Related Life-Threatening or Disabling Bleeding (VARC-3)
Time frame: At 30 days and 12 months post-procedure
Number of Participants Who Experienced Major Bleeding
Time frame: At 30 days and 12 months post-procedure
Number of Participants Who Experienced Minor Bleeding
Time frame: At 30 days and 12 months post-procedure
Number of Participants Who Experienced Aortic Valve Re-Intervention
Time frame: 12 months post-procedure
Number of Participants Who Experienced Heart Failure Re-Hospitalization
Time frame: 12 months post-procedure
Number of Participants Who Experienced Infective Endocarditis
Time frame: 12 months post-procedure
Number of Participants Who Experienced Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: At 30 days and 12 months post-procedure
Number of Participants Who Experienced NYHA Class Improvement
Time frame: At 30 days and 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin and Warfarin in people with Aortic Regurgitation Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lai Wei, MD (+86-021-64041990, Wei.lai@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Non-hierarchical Composite Endpoint (time frame: 12 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.