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XENITH: Rivaroxaban for Pulmonary Embolism Managed With Catheter Directed Thrombolysis (XENITH)

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ClinicalTrials.gov Identifier: NCT02506985
Recruitment Status : Terminated
First Posted : July 23, 2015
Results First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Susan Smyth, University of Kentucky

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pulmonary Embolism
Venous Thrombosis
Interventions Drug: rivaroxaban
Drug: warfarin
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rivaroxaban Heparin-warfarin
Hide Arm/Group Description

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.

rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily.

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).

warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3.

Period Title: Overall Study
Started 4 6
Completed 4 6
Not Completed 0 0
Arm/Group Title Rivaroxaban Heparin-warfarin Total
Hide Arm/Group Description

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.

rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily.

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).

warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3.

Total of all reporting groups
Overall Number of Baseline Participants 4 6 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 6 participants 10 participants
54.5  (17.5) 50.3  (12.5) 52.8  (15.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 10 participants
Female
1
  25.0%
3
  50.0%
4
  40.0%
Male
3
  75.0%
3
  50.0%
6
  60.0%
1.Primary Outcome
Title Change in Markers of NETosis at 12h Compared to Baseline
Hide Description Change in Markers of NETosis at 12h Compared to Baseline
Time Frame 12h
Hide Outcome Measure Data
Hide Analysis Population Description
Sponsor terminated this study and withdrew funding prior to sample analysis. Therefore there was no funding to purchase assays to measure the collected samples nor was there enough samples to complete an assay.
Arm/Group Title Rivaroxaban Heparin-warfarin
Hide Arm/Group Description:

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.

rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily.

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).

warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Change in Markers of NETosis at 24h Compared to Baseline
Hide Description Values will be reported in comparison to baseline in the two treatment groups.
Time Frame 24h
Hide Outcome Measure Data
Hide Analysis Population Description
Sponsor terminated this study and withdrew funding prior to sample analysis. Therefore there was no funding to purchase assays to measure the collected samples nor was there enough samples to complete an assay.
Arm/Group Title Rivaroxaban Heparin-warfarin
Hide Arm/Group Description:

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.

rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily.

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).

warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Change in Markers of NETosis at 48h Compared to Baseline
Hide Description Values will be reported in comparison to baseline in the two treatment groups.
Time Frame 48h
Hide Outcome Measure Data
Hide Analysis Population Description
Sponsor terminated this study and withdrew funding prior to sample analysis. Therefore there was no funding to purchase assays to measure the collected samples nor was there enough samples to complete an assay.
Arm/Group Title Rivaroxaban Heparin-warfarin
Hide Arm/Group Description:

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.

rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily.

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).

warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Change in Markers of NETosis at 5 Days (or Day of Hospital Discharge) Compared to Baseline
Hide Description Change in Markers of NETosis at 5 days (or day of hospital discharge) Compared to Baseline. Values will be reported in comparison to baseline in the two treatment groups.
Time Frame 5 days (or day of hospital discharge)
Hide Outcome Measure Data
Hide Analysis Population Description
Sponsor terminated this study and withdrew funding prior to sample analysis. Therefore there was no funding to purchase assays to measure the collected samples nor was there enough samples to complete an assay.
Arm/Group Title Rivaroxaban Heparin-warfarin
Hide Arm/Group Description:

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.

rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily.

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).

warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Change in Markers of NETosis at 30 Days Compared to Baseline
Hide Description Values will be reported in comparison to baseline in the two treatment groups.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Sponsor terminated this study and withdrew funding prior to sample analysis. Therefore there was no funding to purchase assays to measure the collected samples nor was there enough samples to complete an assay.
Arm/Group Title Rivaroxaban Heparin-warfarin
Hide Arm/Group Description:

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.

rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily.

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).

warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 30 days after hospital discharge
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rivaroxaban Heparin-warfarin
Hide Arm/Group Description

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.

rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily.

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).

warfarin: Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3.

All-Cause Mortality
Rivaroxaban Heparin-warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Rivaroxaban Heparin-warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rivaroxaban Heparin-warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/6 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan Smyth
Organization: University of Kentucky
Phone: 859-323-2274
EMail: susansmyth@uky.edu
Publications:
Layout table for additonal information
Responsible Party: Susan Smyth, University of Kentucky
ClinicalTrials.gov Identifier: NCT02506985     History of Changes
Other Study ID Numbers: 15-0275-F6A
First Submitted: June 17, 2015
First Posted: July 23, 2015
Results First Submitted: February 15, 2018
Results First Posted: September 27, 2018
Last Update Posted: September 27, 2018