At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized 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) - Substudy of the GALILEO-trial
In Brief
A Phase 3 clinical trial evaluating Acetylsalicylic acid, Clopidogrel, and 1 other intervention for Aortic Valve Stenosis and 4 related conditions. Completed, enrolled 231 participants across 25 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
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)