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)
Condition: Aortic Valve Stenosis; Cardiovascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Thrombosis
MeSH terms: Cardiovascular Diseases; Thrombosis; Aortic Valve Stenosis; Heart Valve Diseases; Ventricular Outflow Obstruction
Intervention: Acetylsalicylic acid; Clopidogrel; Rivaroxaban
Intervention description: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1); Drug: Clopidogrel 75 mg OD for first 90 days; Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
Intervention MeSH terms: Aspirin; Rivaroxaban; Clopidogrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Valve Disease; Randomized Controlled Trial; Transcatheter Aortic Valve Replacement; TAVR; Valve Thrombosis

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful TAVR of a native aortic valve stenosis

          -  By iliofemoral or subclavian access

          -  With any approved/marketed TAVR device

          -  Written informed consent

        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

          -  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