NCT02248610

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,343

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2015

Enrollment Period

5.8 years

First QC Date

September 8, 2014

Last Update Submit

August 11, 2020

Conditions

Venous Thromboembolism

Keywords

Pulmonary embolismPEDeep vein thrombosisDVTRivaroxabanVenous thromboembolismChronic thromboembolic pulmonary hypertensionPost thrombotic limb syndromeRoot cause analysis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • 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)

  • +2 more secondary outcomes

Other Outcomes (4)

  • 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

  • +1 more other outcomes

Study Arms (1)

Rivaroxaban

All participants will be treated with rivaroxaban.

Other: Non-interventional study

Interventions

Non-interventional studyOTHER
Rivaroxaban

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18-99 years with acute DVT or PE treated with rivaroxaban, patients will have not recieved bridging anticoagulation

You may qualify if:

  • Patients aged 18 years or older with an objectively verified diagnosis of DVT and/or PE and treated according to routine clinical practice with Rivaroxaban

You may not qualify if:

  • Patients in whom follow-up is unlikely or impossible
  • Patients unable to give consent
  • Patients who receive heparin therapy for more than 48 hours
  • Patients who receive more than one dose of warfarin
  • Patients with an indication for anticoagulation other than DVT and/or PE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Basingstoke Hospital

Basingstoke, United Kingdom

Location

Bournemouth Hospital

Bournemouth, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Salisbury Hospital

Salisbury, United Kingdom

Location

MeSH Terms

Conditions

Venous ThromboembolismPulmonary EmbolismVenous Thrombosis

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismThrombosis

Study Officials

  • Roopen Arya, MBChB, PhD

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 25, 2014

Study Start

November 1, 2014

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

August 12, 2020

Record last verified: 2015-08

Locations

GB(4)