Trial Outcomes & Findings for XENITH: Rivaroxaban for Pulmonary Embolism Managed With Catheter Directed Thrombolysis (NCT NCT02506985)
NCT ID: NCT02506985
Last Updated: 2018-09-27
Results Overview
Change in Markers of NETosis at 12h Compared to Baseline
TERMINATED
PHASE4
10 participants
12h
2018-09-27
Participant Flow
Participant milestones
| Measure |
Rivaroxaban
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.
|
Heparin-warfarin
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 Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
XENITH: Rivaroxaban for Pulmonary Embolism Managed With Catheter Directed Thrombolysis
Baseline characteristics by cohort
| Measure |
Rivaroxaban
n=4 Participants
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.
|
Heparin-warfarin
n=6 Participants
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
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12hPopulation: 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.
Change in Markers of NETosis at 12h Compared to Baseline
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24hPopulation: 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.
Values will be reported in comparison to baseline in the two treatment groups.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48hPopulation: 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.
Values will be reported in comparison to baseline in the two treatment groups.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 5 days (or day of hospital discharge)Population: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 daysPopulation: 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.
Values will be reported in comparison to baseline in the two treatment groups.
Outcome measures
Outcome data not reported
Adverse Events
Rivaroxaban
Heparin-warfarin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place