GALILEO

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  190428

• Contact name

  David Hildick-Smith

• Contact email

  David.Hildick-Smith@bsuh.nhs.uk

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2015-001975-30

• Clinicaltrials.gov Identifier

  NCT02556203

• Duration of Study in the UK

  2 years, 5 months, 30 days

• Research summary

  This is 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.
  Patients after valve replacement procedure are at risk of blood clot formation. This blood clot can reduce the blood flow in arteries cutting off the supply of oxygen to the cells. Blood components such as thrombin and platelets play an important role in the formation of a blood plug or clot. In order to prevent this, it is recommended to use oral antiplatelet drugs, such as aspirin and clopidogrel before and after the valve replacement procedure. These medications can reduce the risk of clot formation. However, current data suggest that antiplatelet based therapy alone with aspirin and clopidogrel may not be optimal treatment for patients after TAVR procedure.

  The purpose of this study is to evaluate whether rivaroxaban is effective and safe in preventing clot formation in the blood in patients after TAVR procedure.
  Rivaraxoban is already a marketed product in other conditions such as prevention of blood clots after major hip or knee surgery and others. However, the aim of this study is evaluate rivaroxaban for clot prevention in patients after TAVR procedure.

  In this study patients will be randomized to receive either rivaroxaban based therapy or standard anti platelet therapy. Patients will remain in the study until predefined number of efficacy endpoints is collected. It is expected this will be reached in around 720 days after first patient is recruited in the study. For individual patients it is expected to have average follow up duration of 18 Months with the range between 12 to 24 Months. Post-treatment follow up will be 30 days for all patients.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  16/EM/0007

• Date of REC Opinion

  26 Feb 2016

• REC opinion

  Further Information Favourable Opinion