XENITH: Rivaroxaban for Pulmonary Embolism Managed With Catheter Directed Thrombolysis

• Status: Terminated
• Trial end date: 2016-06-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Susan Smyth; University of Kentucky
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Calcium heparin; Heparin; Polystyrene sulfonic acid; Rivaroxaban; Warfarin

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