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

7 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

1172

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine
        • Recrutement
        • Zhongshan hospital, Fudan university
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Aspirin Monotherapy
Aspirin 75-100 mg orally once daily for 12 months
Médicament: Aspirin
Aspirin 75-100 mg orally once daily
Comparateur actif: Standard Therapy
Warfarin (INR 2-3) for 6 months, followed by Aspirin 75-100 mg once daily for 6 months
Médicament: Aspirin
Aspirin 75-100 mg orally once daily
Médicament: Warfarin
Warfarin orally with dose adjusted to maintain INR 2-3

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants Who Experienced Non-hierarchical Composite Endpoint
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants Who Experienced Composite Endpoint of All-Cause Death, Ischemic Stroke, Valve/Intracardiac Thrombosis, and Myocardial Infarction.
Délai: 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)
Délai: 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
Délai: 12 months post-procedure
12 months post-procedure
Number of Participants Who Experience Clinical Efficacy Composite Endpoint
Délai: 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
Délai: 12 months post-procedure
12 months post-procedure
Number of Participants Who Experience Clinically Significant Prosthetic Valve Thrombosis (VARC-3)
Délai: 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)
Délai: 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
Délai: 12 months post-procedure
12 months post-procedure
Number of Participants Who Experienced Non-Procedure-Related Life-Threatening or Disabling Bleeding (VARC-3)
Délai: At 30 days and 12 months post-procedure
At 30 days and 12 months post-procedure
Number of Participants Who Experienced Major Bleeding
Délai: 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
Délai: 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
Délai: 12 months post-procedure
12 months post-procedure
Number of Participants Who Experienced Heart Failure Re-Hospitalization
Délai: 12 months post-procedure
12 months post-procedure
Number of Participants Who Experienced Infective Endocarditis
Délai: 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)
Délai: 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
Délai: At 30 days and 12 months post-procedure
At 30 days and 12 months post-procedure

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shanghai Zhongshan Hospital

Collaborateurs

Suzhou Jiecheng Medical Technology Co., Ltd.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 juillet 2026

Achèvement primaire (Estimé)

1 juillet 2029

Achèvement de l'étude (Estimé)

1 juillet 2030

Dates d'inscription aux études

Première soumission

23 juin 2026

Première soumission répondant aux critères de contrôle qualité

27 juin 2026

Première publication (Réel)

30 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KY2026134

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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