XENITH: Rivaroxaban for Pulmonary Embolism Managed With Catheter Directed Thrombolysis (XENITH)
Pulmonary Embolism, Venous Thrombosis
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring Rivaroxaban, CDT (Catheter directed thrombolysis), PE (pulmonary embolism), NETs, factor Xa
Eligibility Criteria
Inclusion Criteria:
- Provisions of informed consent prior to any study specific procedure
- Diagnosis of acute PE
- Evidence of RV strain as defined by one of the following:
- 1. an RV-to-LV diameter ratio>0.9
- 2. elevated troponin
- 3. elevated BNP
- Plan for CDT for PE.
Exclusion Criteria:
- Arterial hypotension and cardiogenic shock at the time of enrollment. Arterial hypotension defined as a systolic arterial pressure <90mm Hg or a drop in systolic arterial pressure of at least 40 mm Hg for at least 15 minutes with tissue hypoperfusion and/or hypoxia)
- Hypersensitivity or other reaction to rivaroxaban
- Other indication for VKA than PE
- Creatinine clearance <30 ml/min
- Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALT > 3 x ULN
- Life expectancy <3 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
rivaroxaban
heparin-warfarin
For the first 3 weeks, patients will receive rivaroxaban 15mg twice-daily; thereafter they will take rivaroxaban 20mg once-daily as per the drug label. Rivaroxaban will be initiated immediately following completion of alterplase infusion, and heparin will be discontinued at the time of rivaroxaban administration.
Unfractioned heparin (UFH), following hospital protocol to achieve a target PTT or enoxaparin, 1.0mg/kg twice-daily, for a minimal duration of treatment of 5 days. Warfarin may be started on the night after CDT. UFH or enoxaparin should continue until the INR is >= 2.0 on two consecutive measurements at least 24 hours apart with an advised overlap with VKA for 4 to 5 days. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0).