Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis

PHASE3CompletedINTERVENTIONAL
Enrollment

1,510

Participants

Timeline

Start Date

August 26, 2016

Primary Completion Date

October 15, 2020

Study Completion Date

October 15, 2020

Conditions
Symptomatic Aortic StenosisEligible for Transcatheter Aortic Valve Replacement
Interventions
DRUG

Apixaban

"Investigational Product is open label apixaban 5 mg tablets taken orally two times a day for 12 months. Subjects with 2 or more of the following characteristics will take apixaban 2.5 mg tablets orally twice daily: age ≥80 years, body weight \<60 kg, serum creatinine ≥1.5 mg/dL \[133 μMol/L\].~\- Also, subjects with severe renal insufficiency \[calculated Creatinine Clearance (Cr.Cl.) (Cockroft-Gault) between 15-29 ml/min\] will take apixaban 2.5 mg tablets orally twice daily"

DRUG

Standard of care

VKA or Antiplatelet therapy

Trial Locations (4)

54100

Unità Operativa di Cardiologia Fondazione Gabriele Monasterio C.N.R., Massa

75013

ACTION Study Group, Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC, Paris

79189

Division of Cardiology and Angiology II, University Heart Center Freiburg, Bad Krozingen

08907

Hospitalet de Llobregat-Hospital Universitari de Bellvitge, Barcelona

All Listed Sponsors
collaborator

Action Research Group

OTHER

collaborator

Bristol-Meyers Squibb & Pfizer

UNKNOWN

lead

Assistance Publique - Hôpitaux de Paris

OTHER