XENITH: Rivaroxaban for Pulmonary Embolism Managed With Catheter Directed Thrombolysis
Status:
Terminated
Trial end date:
2016-06-29
Target enrollment:
Participant gender:
Summary
The trial is an open-label, randomized, trial examining novel biomarkers of thrombosis in
patients managed with rivaroxaban vs. standard care following treatment of pulmonary embolism
(PE) with catheter-guided alteplase. Patients >18 years old who present with PE and are
managed with catheter-guided alteplase will be screened for study inclusion. Patient's
meeting inclusion/exclusion criteria will undergo informed consent. Immediately following
completion of alteplase infusion, patients will be randomized to receipt of rivaroxaban 15 mg
oral bid for 21 days followed by 20mg oral daily or continuation on unfractioned heparin or
low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3. Blood
samples will be taken within 2 hours of CDT completion prior to receipt of study treatment
(study day 1), at 8h-12h, 24h, 48h, 5d (or prior to hospital discharge), and at 30 day
follow-up. Clinical endpoints, including bleeding, evidence of thrombosis progression, and
death will be tracked during index hospitalization and at follow-up 30 days post-discharge.