NCT02248610|CompletedDMC
Follow-up in Rivaroxaban Patients in Setting of Thromboembolism
FIRST
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FIRST
Sponsor study identifier
observational
1,343
1 country
4
Study Start
November 2014
Actual (reported)Primary Completion
July 31, 2020
Actual (reported)Study Completion
July 31, 2020
Actual (reported)In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators will collect real world data on their short and long term outcomes. The investigators hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2. there will be less bleeding than when patients are on conventional anticoagulants; 3. there will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary hypertension and post-thrombotic limb syndrome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 8, 2014
Actual (reported)September 25, 2014
Actual (reported)November 2014
Actual (reported)July 31, 2020
Actual (reported)July 31, 2020
Actual (reported)Incidence of long term complications
Incidence of long term complications as composite primary end point of VTE recurrence, PTS and CTEPH in patients treated with rivaroxaban without bridging heparin therapy
5 years from diagnosis of index event (DVT or PE), annual follow-up
Incidence of major post-thrombotic complications
5 years from diagnosis of index event (DVT or PE), annual follow-up
Incidence of treatment-emergent bleeding rates
5 years from diagnosis of index event (DVT or PE), annual follow-up
All-cause mortality
5 years from diagnosis of index event (DVT or PE), annual follow-up
Treatment adherence
Full duration of anticoagulation treatment (average of 6 months)
Quality of life assessment
Full duration of anticoagulation treatment (average of 6 months)
Exploratory root-cause analysis of major bleeding and recurrent VTE events
5 years from diagnosis of index event (DVT or PE), annual follow-up
Analysis of the outpatient treatment of PE
Full duration of outpatient care (every clinic visit), until discharge (average of 6 months, 3 patient visits)
Subgroup analysis of patients with evidence of long-term VTE-related morbidity
5 years from diagnosis of index event (DVT or PE), annual follow-up
All participants will be treated with rivaroxaban.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients aged 18-99 years with acute DVT or PE treated with rivaroxaban, patients will have not recieved bridging anticoagulation
Basingstoke Hospital
Basingstoke, United Kingdom
Bournemouth Hospital
Bournemouth, United Kingdom
Kings College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Salisbury Hospital
Salisbury, United Kingdom
Roopen Arya, MBChB, PhD
King's College Hospital NHS Trust
1,343 participants (actual enrollment reported by the registry).
First Submitted
September 8, 2014
First Posted
September 25, 2014
Study Start
November 2014
Actual (reported)Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
Contact the study team to confirm eligibility.
Primary Completion
July 31, 2020
Actual (reported)Study Completion
July 31, 2020
Actual (reported)Last Updated
August 12, 2020
Record last verified: 2015-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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