Brief description of trial (Data source: BASEC)
Es wird untersucht, ob nach einem Aortenklappenersatz unter Verwendung von Kathetern (TAVI) eine Behandlung mit dem Blutverdünner Rivaroxaban gegenüber einer Behandlung mit Plättchenhemmern überlegen ist in der Verhinderung von Tod oder dem Auftreten von Blutgerinnseln.
Es wird im Weiteren das Auftreten primärer Blutungsereignisse nach TAVI bei Behandlung mit Rivaroxaban oder Plättchenhemmern miteinander verglichen.
Health conditions investigated(Data source: BASEC)
Transkatheter-Aortenklappenimplantation (TAVI)
Health conditions
(Data source: WHO)
Transcatheter Aortic Valve Replacement
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Behandlung mit Rivaroxaban (Xarelto, BAY59-7939)
Interventions
(Data source: WHO)
Drug: Rivaroxaban (Xarelto, BAY59-7939);Drug: Acetylsalicylic Acid (ASA);Drug: Clopidogrel;Drug: Vitamin K antagonist (VKA)
Criteria for participation in trial
(Data source: BASEC)
- Erfolgreich durchgeführter Aortenklappenersatz
- Der Zugang zur Aortenklappe muss durch ganz bestimmte Blutgefässe erfolgt sein
- Einsatz eines zugelassenen Implantats
Exclusion criteria
(Data source: BASEC)
- Vorhofflimmern, aktuell oder in der Vergangenheit, welches mit oralen Blutverdünnern behandelt werden muss
- Jegliche sonstige Indikation für eine Behandlung mit oralen Blutverdünnern
- Bekannte Blutungsneigung
-Indikation zur Behandlung mit doppelter Plättchenhemmung
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
-
Further information on trial
Date trial registered
Sep 5, 2015
Incorporation of the first participant
Dec 16, 2015
Recruitment status
Terminated
Academic title
(Data source: WHO)
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
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Number of Participants With Primary Bleeding Event (PBE);Number of Participants With Death or First Thromboembolic Event (DTE)
Secundary end point
(Data source: WHO)
Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds;Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds;Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds;Number of Participants With Cardiovascular Death or Thromboembolic Event;Number of Participants With Net-clinical Benefit
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, Bern, Lugano, Luzern, Zurich
Countries
(Data source: WHO)
Austria, Belgium, Canada, Czech Republic, Czechia, Denmark, France, Germany, Italy, Korea, Netherlands, Norway, Poland, Republic of, Spain, Sweden, Switzerland, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Simon Rotzler
+41444658111
clinical.operations.switzerland@bayer.com
Contact for general information
(Data source: WHO)
Bayer Study Director
Bayer
Contact for scientific information
(Data source: WHO)
Bayer Study Director
Bayer
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Bern
Date of authorisation by the ethics committee
09.03.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2015-00143
Secondary ID (Data source: WHO)
2015-001975-30
17938
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