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

29. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

1172

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Zhongshan Hospital, Fudan University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Aspirin Monotherapy
Aspirin 75-100 mg orally once daily for 12 months
Arzneimittel: Aspirin
Aspirin 75-100 mg orally once daily
Aktiver Komparator: Standard Therapy
Warfarin (INR 2-3) for 6 months, followed by Aspirin 75-100 mg once daily for 6 months
Arzneimittel: Aspirin
Aspirin 75-100 mg orally once daily
Arzneimittel: Warfarin
Warfarin orally with dose adjusted to maintain INR 2-3

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Who Experienced Non-hierarchical Composite Endpoint
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shanghai Zhongshan Hospital

Mitarbeiter

Suzhou Jiecheng Medical Technology Co., Ltd.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Juli 2029

Studienabschluss (Geschätzt)

1. Juli 2030

Studienanmeldedaten

Zuerst eingereicht

23. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Juni 2026

Zuerst gepostet (Tatsächlich)

30. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KY2026134

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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