TerminatedPhase 4

XENITH: Rivaroxaban for Pulmonary Embolism Managed With Catheter Directed Thrombolysis

10 participantsStarted 2015-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Markers of NETosis at 12h Compared to Baseline

Timeframe: 12h

Change in Markers of NETosis at 24h Compared to Baseline

Timeframe: 24h

Change in Markers of NETosis at 48h Compared to Baseline

Timeframe: 48h

Change in Markers of NETosis at 5 Days (or Day of Hospital Discharge) Compared to Baseline

Timeframe: 5 days (or day of hospital discharge)

Change in Markers of NETosis at 30 Days Compared to Baseline

Timeframe: 30 days

Trial details

NCT IDNCT02506985

SponsorSusan Smyth

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06-29

Results submitted2018-02-15

View on ClinicalTrials.gov More Pulmonary Embolism trials