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Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation (AWATAR)

7 augustus 2026 bijgewerkt door: Wei Lai, MD, Shanghai Zhongshan Hospital

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

1172

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Werving
        • Zhongshan hospital, Fudan university
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Aspirin Monotherapy
Aspirin 75-100 mg orally once daily for 12 months
Geneesmiddel: Aspirin
Aspirin 75-100 mg orally once daily
Actieve vergelijker: Standard Therapy
Warfarin (INR 2-3) for 6 months, followed by Aspirin 75-100 mg once daily for 6 months
Geneesmiddel: Aspirin
Aspirin 75-100 mg orally once daily
Geneesmiddel: Warfarin
Warfarin orally with dose adjusted to maintain INR 2-3

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Who Experienced Non-hierarchical Composite Endpoint
Tijdsspanne: 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).
12 months post-procedure

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Who Experienced Composite Endpoint of All-Cause Death, Ischemic Stroke, Valve/Intracardiac Thrombosis, and Myocardial Infarction.
Tijdsspanne: 12 months post-procedure
The first key secondary endpoint is composite of all-cause death, ischemic stroke, valve/intracardiac thrombosis, and myocardial infarction.
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)
Tijdsspanne: 12 months post-procedure

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
Tijdsspanne: 12 months post-procedure
12 months post-procedure
Number of Participants Who Experience Clinical Efficacy Composite Endpoint
Tijdsspanne: 12 months post-procedure
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
Tijdsspanne: 12 months post-procedure
12 months post-procedure
Number of Participants Who Experience Clinically Significant Prosthetic Valve Thrombosis (VARC-3)
Tijdsspanne: At 6 months and 12 months post-procedure
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)
Tijdsspanne: 12 months post-procedure
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
Tijdsspanne: 12 months post-procedure
12 months post-procedure
Number of Participants Who Experienced Non-Procedure-Related Life-Threatening or Disabling Bleeding (VARC-3)
Tijdsspanne: At 30 days and 12 months post-procedure
At 30 days and 12 months post-procedure
Number of Participants Who Experienced Major Bleeding
Tijdsspanne: At 30 days and 12 months post-procedure
Based on VARC 2 criteria
At 30 days and 12 months post-procedure
Number of Participants Who Experienced Minor Bleeding
Tijdsspanne: At 30 days and 12 months post-procedure
Based on VARC 2 criteria
At 30 days and 12 months post-procedure
Number of Participants Who Experienced Aortic Valve Re-Intervention
Tijdsspanne: 12 months post-procedure
12 months post-procedure
Number of Participants Who Experienced Heart Failure Re-Hospitalization
Tijdsspanne: 12 months post-procedure
12 months post-procedure
Number of Participants Who Experienced Infective Endocarditis
Tijdsspanne: 12 months post-procedure

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)
Tijdsspanne: At 30 days and 12 months post-procedure
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
Tijdsspanne: At 30 days and 12 months post-procedure
At 30 days and 12 months post-procedure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai Zhongshan Hospital

Medewerkers

Suzhou Jiecheng Medical Technology Co., Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 juli 2026

Primaire voltooiing (Geschat)

1 juli 2029

Studie voltooiing (Geschat)

1 juli 2030

Studieregistratiedata

Eerst ingediend

23 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 juni 2026

Eerst geplaatst (Werkelijk)

30 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

7 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KY2026134

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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