Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)

PHASE3CompletedINTERVENTIONAL
Enrollment

231

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

December 31, 2018

Study Completion Date

March 6, 2019

Conditions
Aortic Valve StenosisCardiovascular DiseasesHeart Valve DiseasesVentricular Outflow ObstructionThrombosis
Interventions
DRUG

Acetylsalicylic acid

"Drug: Acetylsalicylic acid:~75 - 100 mg OD (for first 90 days only in arm 1)"

DRUG

Clopidogrel

Drug: Clopidogrel 75 mg OD for first 90 days

DRUG

Rivaroxaban

"Drug: Rivaroxaban (Xarelto):~10 mg OD (once-daily)"

Trial Locations (25)

1105

Academic Medical Center, Amsterdam

2100

Rigshospitalet, Copenhagen

3010

Inselspital, Bern

3015

Erasmus M.C, Rotterdam

4056

University Hospital Basel, Basel

4818

Amphia Zienkenhuis, Breda

5000

Odense University Hospital, Odense

8000

Aarhus university hospital, Aarhus

10117

Charité- Universitätsmedizin Berlin - Campus Mitte, Berlin

13353

Deutsches Herzzentrum Berlin, Berlin

19104

Hospital of the University of Pennsylvania, Philadelphia

24105

Universitätsklinikum Schleswig-Holstein, Kiel

44137

St. Johannes Hospital, Dortmund

61231

Kerckhoff Klinik GmbH, Bad Nauheim

77933

Medicin Herzzentrum Lahr/Baden, Lahr

78229

University of Texas, Health Science Center, Houston

80636

Deutsches Herzzentrum München, München

90048

Cedars Sinai Medical Center, Los Angeles

91012

Universitätsklinikum Erlangen, Erlangen

10029-6574

Mount Sinai M.C, New York

AB T6G 2B7

University of Alberta Hospital, Edmonton

ON M1L 1W1

Providence Health Care, Vancouver

04289

Herzzentrum Leipzig - Universitätsklinik, Leipzig

SE-205 02

Skåne University Hospital, Lund

SE-171 76

Karolinska University Hospital, Stockholm

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Rigshospitalet, Denmark

OTHER

collaborator

Bayer

INDUSTRY

collaborator

Cardialysis BV

INDUSTRY

lead

ECRI bv

INDUSTRY