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)
Completed · Phase 3
Conditions studied: Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Ventricular Outflow Obstruction, Thrombosis
In brief
The aortic valve is located between the left ventricle and the aorta. Patients with symptomatic, severe aortic valve stenosis conventionally have it surgically replaced requiring direct access to the heart through the chest. Transcatheter aortic valve replacement (TAVR) is now a well-established alternative for treating severe aortic valve stenosis. Both types of intervention improve prognosis and alleviate symptoms. The optimal choice of blood thinning therapy after TAVR is unknown. It has been reported that leaflet thrombosis with reduced leaflet motion can occur and this phenomenon has been suggested to be potentially related with neurological events. In addition, the occurence of this phenomenon can be reduced with anticoagulation blood thinning therapy. The purpose of this study is to evaluate if anticoagulation compared to the usual double platelet inhibitor therapy after TAVR can reduce the risk of leaflet thrombosis.
Key facts
- Study ID
- NCT02833948
- Run by
- ECRI bv
- People needed
- 231
- Starts
- 2016-05-01
- Expected to finish
- 2019-03-06
- Last updated by the study team
- 2020-01-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Successful TAVR of a native aortic valve stenosis
- By iliofemoral or subclavian access
- With any approved/marketed TAVR device
- Written informed consent
You may not qualify if…
- Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant treatment
- Any other indication for continued treatment with any oral anticoagulant
- Known bleeding diathesis (such as but not limited to platelet count ≤ 50,000/mm3 at screening, hemoglobin level < 8.5 g/dL or < 5.3 mmol/l, history of intracranial hemorrhage, or subdural hematoma)
- Any indication for dual antiplatelet therapy (DAPT) for more than three months after randomization (such as coronary, carotid, or peripheral stent implantation)
- Clinically overt stroke within the last three months
- Planned coronary or vascular intervention or major surgery
- Severe renal insufficiency (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction ≥ stage 2
- Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
- Iodine contrast allergy or other condition that prohibits CT imaging
Where it is running
- Cedars Sinai Medical Center — Los Angeles, California, United States
- Mount Sinai M.C — New York, New York, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Texas, Health Science Center — Houston, Texas, United States
- University of Alberta Hospital — Edmonton, Canada
- Providence Health Care — Vancouver, Canada
- Aarhus university hospital — Aarhus, Denmark
- Rigshospitalet — Copenhagen, Denmark
- Odense University Hospital — Odense, Denmark
- Kerckhoff Klinik GmbH — Bad Nauheim, Germany
- Charité- Universitätsmedizin Berlin - Campus Mitte — Berlin, Germany
- Deutsches Herzzentrum Berlin — Berlin, Germany
- St. Johannes Hospital — Dortmund, Germany
- Universitätsklinikum Erlangen — Erlangen, Germany
- Universitätsklinikum Schleswig-Holstein — Kiel, Germany
- Medicin Herzzentrum Lahr/Baden — Lahr, Germany
- Herzzentrum Leipzig - Universitätsklinik — Leipzig, Germany
- Deutsches Herzzentrum München — München, Germany
- Academic Medical Center — Amsterdam, Netherlands
- Amphia Zienkenhuis — Breda, Netherlands
- Erasmus M.C — Rotterdam, Netherlands
- Skåne University Hospital — Lund, Sweden
- Karolinska University Hospital — Stockholm, Sweden
- University Hospital Basel — Basel, Switzerland
- Inselspital — Bern, Switzerland
Full record on ClinicalTrials.gov
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