stop_circleTerminated/Withdrawn

Transcatheter Aortic Valve Replacement

Bayer Identifier:

17938

ClinicalTrials.gov Identifier:

NCT02556203

EudraCT Number:

2015-001975-30

EU CT Number:

Not Available
Global study comparing a rivAroxaban-based antithrombotic strategy to an antipLatelet-based strategy after transcatheter aortIc vaLve rEplacement to Optimize clinical outcomes

Trial purpose

To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).
To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an antiplatelet-based strategy, following TAVR.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Successful TAVR (Transcatheter Aortic Valve Replacement) of an aortic valve stenosis (either native
    or valve-in-valve)
     -- By iliofemoral or subclavian access
     -- With any approved/marketed device
  • - Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant treatment
    - Any other indication for continued treatment with any oral anticoagulant (OAC)
    - Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma)
    - Any ongoing absolute indication for dual antiplatelet therapy (DAPT) at time of screening that is unrelated to the TAVR procedure
    - Clinically overt stroke within the last 3 months
    - Planned coronary or vascular intervention or major surgery
    - Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher
    - Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy

Trial summary

Enrollment Goal
1653
Trial Dates
December 2015 - November 2018
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Graz, 8036, Austria
Completed
Wien, 1090, Austria
Completed
Wien, 1130, Austria
Completed
Wels, 4600, Austria
Completed
Salzburg, 5020, Austria
Completed
Linz, 4020, Austria
Completed
Brno, 656 91, Czech Republic
Completed
Bad Nauheim, 61231, Germany
Completed
Bad Berka, 99437, Germany
Completed
Bad Neustadt, 97616, Germany
Completed
Bad Segeberg, 23795, Germany
Completed
Erlangen, 91054, Germany
Completed
Berlin, 10117, Germany
Completed
Magdeburg, 39120, Germany
Completed
Mainz, 55131, Germany
Completed
Regensburg, 93042, Germany
Completed
Bonn, 53105, Germany
Withdrawn
Universitätsklinikum HeidelbergHeidelberg, 69115, Germany
Completed
Köln, 50924, Germany
Completed
Lahr, 77033, Germany
Completed
München, 80331, Germany
Completed
Rotenburg a.d. Fulda, 36199, Germany
Completed
Tübingen, 72076, Germany
Completed
Berlin, 12200, Germany
Completed
Bern, 3010, Switzerland
Completed
Basel, 4056, Switzerland
Completed
Luzern, 6000, Switzerland
Completed
Zürich, 8091, Switzerland
Completed
Madrid, 28046, Spain
Completed
Oviedo, 33011, Spain
Completed
Málaga, 29010, Spain
Completed
Barcelona, 08036, Spain
Completed
L'Hospitalet de Llobregat, 08907, Spain
Completed
Berlin, 13353, Germany
Completed
Düsseldorf, 40225, Germany
Completed
Hamburg, 20246, Germany
Completed
Hannover, 30625, Germany
Withdrawn
Marburg, 35043, Germany
Completed
Neuss, 41464, Germany
Withdrawn
SHG-Kliniken VölklingenVölklingen, 66333, Germany
Recruiting
Fulda, 36043, Germany
Completed
BREST, 29609, France
Completed
Praha 10, 10034, Czech Republic
Completed
Praha 4, 140 21, Czech Republic
Withdrawn
Olomouc, 775 20, Czech Republic
Completed
Bielsko-Biala, 43-316, Poland
Completed
Warszawa, 04-628, Poland
Completed
Warszawa, 02-097, Poland
Completed
Brighton, BN2 5BE, United Kingdom
Completed
Leeds, LS1 3EX, United Kingdom
Completed
Leicester, LE3 9QP, United Kingdom
Completed
London, SE1 7EH, United Kingdom
Completed
Belfast, BT12 6BA, United Kingdom
Withdrawn
Birmingham, B15 2TH, United Kingdom
Completed
Edinburgh, EH16 4SA, United Kingdom
Completed
Blackpool, FY3 8NR, United Kingdom
Completed
Wien, 1160, Austria
Recruiting
Krefeld, 47805, Germany
Completed
Freiburg, 79106, Germany
Completed
Leipzig, 04289, Germany
Completed
Kiel, 24105, Germany
Completed
New York, 10029, United States
Completed
Catania, 95124, Italy
Completed
Milano, 20162, Italy
Completed
Charlottesville, 22908, United States
Completed
Philadelphia, 19104, United States
Completed
Plano, 75093, United States
Completed
Chicago, 60611, United States
Withdrawn
Baltimore, 21287-6568, United States
Completed
Baltimore, 21201, United States
Completed
Burlington, 05401, United States
Completed
Kansas City, 64111, United States
Completed
LIEGE, 4000, Belgium
Completed
HASSELT, 3500, Belgium
Completed
GENK, 3600, Belgium
Completed
Bergamo, 24127, Italy
Completed
Milano, 20089, Italy
Completed
Padova, 35128, Italy
Completed
Milano, 20132, Italy
Withdrawn
Pavia, 27100, Italy
Completed
Pisa, 56124, Italy
Completed
Winston-Salem, 27157-1082, United States
Completed
Evanston, 60201, United States
Withdrawn
Springfield, 62769, United States
Completed
Roslyn, 11576, United States
Completed
Houston, 77030-1501, United States
Withdrawn
Valhalla, 10595, United States
Completed
Southampton, SO16 6YD, United Kingdom
Completed
Newcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
Oxford, OX9 3DU, United Kingdom
Completed
London, SE5 9RS, United Kingdom
Completed
AMSTERDAM, 1105 AZ, Netherlands
Withdrawn
AMSTERDAM, 1091 AC, Netherlands
Withdrawn
EINDHOVEN, 5623 EJ, Netherlands
Completed
ROTTERDAM, 3015 CE, Netherlands
Completed
BREDA, 4818 CK, Netherlands
Completed
Copenhagen, DK-2100, Denmark
Completed
Odense C, DK-5000, Denmark
Completed
Oslo, 0424, Norway
Completed
Tromsø, 9038, Norway
Completed
Bergen, N-5021, Norway
Completed
TOULOUSE, 31300, France
Completed
Chambray-lès-Tours, 37170, France
Withdrawn
CRETEIL, 94010, France
Completed
Angers, 49100, France
Completed
LILLE, 59000, France
Withdrawn
Stockholm, 171 76, Sweden
Completed
Uppsala, 751 85, Sweden
Completed
Newmarket, L3Y 2P7, Canada
Completed
Edmonton, T6G 2B7, Canada
Completed
Toronto, M5G 2C4, Canada
Completed
Vancouver, V6A 1Y6, Canada
Completed
Victoria, V8R 4R2, Canada
Not yet recruiting
Seoul, 06351, Korea, Republic Of
Not yet recruiting
Seoul, 110-744, Korea, Republic Of
Not yet recruiting
Seoul, 06591, Korea, Republic Of
Not yet recruiting
Seoul, 120-752, Korea, Republic Of
Completed
Houston, 77030, United States
Completed
Washington, 20010, United States
Completed
Cincinnati, 45219, United States
Withdrawn
Albany, 12208, United States
Withdrawn
St. Louis, 63110, United States
Completed
Detroit, 48202, United States
Withdrawn
New Orleans, 70121, United States
Completed
Miami, 33136, United States
Completed
Clearwater, 33756, United States
Completed
Atlanta, 30322, United States
Completed
Wilkes-Barre, 18711-3752, United States
Completed
Manhasset, 11030-3876, United States
Withdrawn
Boston, 02115-6195, United States
Completed
Los Angeles, 90048-0750, United States
Withdrawn
Los Angeles, 90027, United States
Completed
Minneapolis, 55407, United States
Withdrawn
New York, 10032, United States
Completed
München, 81925, Germany
Completed
Frankfurt, 60389, Germany
Completed
Dortmund, 44137, Germany
Completed
Halifax, B3H 3A7, Canada
Completed
Toronto, M4N 3M5, Canada
Completed
Cleveland, 44195, United States
Completed
Morristown, 07962, United States
Completed
Montreal, H1T 1C8, Canada
Withdrawn
Saint John, E2L 4M2, Canada
Completed
Aachen, 52074, Germany
Completed
Ulm, 89081, Germany
Withdrawn
Rochester, 55905, United States
Withdrawn
Columbus, 43214, United States
Completed
Boston, 02215, United States
Withdrawn
Richmond, 23226-1907, United States
Completed
Winnipeg, R2H 2A6, Canada
Withdrawn
La Jolla, 92037, United States
Withdrawn
Rochester, 14642, United States
Completed
Jacksonville, 32209, United States
Withdrawn
Liverpool, 13088, United States
Withdrawn
Birmingham, 35294, United States
Completed
Aarhus N, 8200, Denmark
Completed
Homburg, 66424, Germany
Completed
Konstanz, 78464, Germany
Withdrawn
New York, 10016-4576, United States
Completed
Tacoma, 98405, United States
Completed
Temple, 76508, United States
Completed
West Des Moines, 50266, United States
Completed
Falls Church, 22042-3300, United States
Withdrawn
Danville, 17822-2001, United States
Completed
München, 80636, Germany
Completed
Lugano, 6900, Switzerland
Withdrawn
Würzburg, 97080, Germany
Withdrawn
Hamburg, 20099, Germany
Completed
Bremen, 28277, Germany
Withdrawn
Nottingham, NG5 1PB, United Kingdom
Terminated
PARIS, 75014, France
Completed
Paris, 75018, France

Primary Outcome

  • Number of subjects with death or adjudicated thromboembolic event (DTE)
    Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).
    date_rangeTime Frame:
    From randomization until end of study medication + 2 days
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects with death or adjudicated thromboembolic event (DTE)
    Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).
    date_rangeTime Frame:
    From randomization until efficacy cut-off date (13-Aug-2018)
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with primary bleeding event (PBE)
    PBE is defined according to VARC(Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.
    date_rangeTime Frame:
    From randomization until efficacy cut-off date (13-Aug-2018)

Secondary Outcome

  • Number of participants with cardiovascular death or thromboembolic event
    Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).
    date_rangeTime Frame:
    From randomization until efficacy cut-off date (13-Aug-2018)
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with Net-clinical benefit
    The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety).
    date_rangeTime Frame:
    From randomization until efficacy cut-off date (13-Aug-2018)
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with TIMI (Thrombolysis In Myocardial Infarction) major / minor bleeds
    Composite of TIMI major and minor bleedings
    date_rangeTime Frame:
    From randomization until efficacy cut-off date (13 August 2018)
  • Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeds
    ISTH major bleeds
    date_rangeTime Frame:
    From randomization until efficacy cut-off date (13 August 2018)
  • Number of participants with composite bleeding endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 bleeds
    Composite of BARC 2,3 or 5 bleedings
    date_rangeTime Frame:
    From randomization until efficacy cut-off date (13 August 2018)
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Global multicenter, open-label, randomized, event-driven, active-controlled study comparing a rivAroxaban-based antithrombotic strategy to an antipLatelet-based strategy after transcatheter aortIc vaLve rEplacement (TAVR) to Optimize clinical outcomes
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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