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Long Term Outcomes of Venous Thromboembolism (LOVE)

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ClinicalTrials.gov Identifier: NCT02268630
Recruitment Status : Recruiting
First Posted : October 20, 2014
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Ostfold Hospital Trust

Brief Summary:

This prospective observational follow-up study is designed to assess the long-term outcomes after Venous thromboembolism (VTE) and to assess the effect of the new oral anticoagulant (NOAC) rivaroxaban on the prevalence of post-thrombotic syndrome (PTS).

The study will not be testing any formal hypothesis.


Condition or disease
Post Thrombotic Syndrome Chronic Thromboembolic Pulmonary Hypertension Venous Thrombosis

Detailed Description:

This prospective observational follow-up study is designed to assess the long-term outcomes after VTE and to assess the effect of NOAC (rivaroxaban) on the prevalence of PTS. All patients diagnosed and treated for VTE at SØF from 01.01.2011 will be invited to participate in this study. Newly diagnosed patients will be recruited and followed-up according to the study schedule which is based on state of the art international guidelines.

First follow-up will be performed at the end of treatment period, which is usually 3 or 6 months after an event of VTE, or at one year if patients will be put on permanent AC. Thereafter, patients will be followed-up annually for at least 5 years or up to the end of the study, i.e for 10 years.

The primary endpoints of the study are the development of PTS and CTEPH after VTE. There will be 3 visits: at 3 or 6 months depending on the duration of AC, at 2 and 5 years, in addition to a visit for TTE at 6 months. Remaining follow-ups will be performed by phone or by mail. All patients with PE will be examined by TTE 6 months after the diagnosis of PE. Those with signs of PAH will be referred for further work-up to establish the presence or absence of CTEPH at specialized centres. Patients with DVT will be evaluated for PTS at 2 and 5 years and for CTEPH if they develop dyspnoea. As for part b of the primary objective, the study will allow inclusion of patients with previous DVT diagnosed after 01.01.11.


Study Type : Observational
Estimated Enrollment : 460 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Long Term Outcomes of Venous Thromboembolism -the LOVE Study-
Study Start Date : January 2014
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Group A
Patients treated with Warfarin for VTE
Grup B
Patients treated with Rivaroxaban for VTE



Primary Outcome Measures :
  1. Prevalence of post thrombotic syndrome and chronic thromboembolic pulmonary hypertension [ Time Frame: 5 years ]

    Determine the prevalence of post thrombotic syndrome as defined by Villalta score at 2- and 5 years in an unselected population of venous thromboembolism patients.

    Prevalence of chronic thromboembolic pulmonary hypertension in at 2- and 5 years in an unselected population of pulmonary embolism patients.



Secondary Outcome Measures :
  1. Bleeding [ Time Frame: 9 years ]
    Rate of bleeding during treatment with anticoagulation

  2. Recurrence rate [ Time Frame: 9 years ]
    Recurrence rate during treatment and after discontinuation of anticoagulation.

  3. Mortality rate [ Time Frame: 9 years ]
    Mortality rate following deep vein thrombosis and /or pulmonary embolism.

  4. Severity of pulmonary embolism [ Time Frame: 9 years ]
    Severity of PE based on CT (Fredrikstad score) and troponin level.

  5. Incidence of cancer [ Time Frame: 9 years ]
    Incidence of cancer after diagnosis of venous tromboembolism in screened and unscreened patients

  6. Compliance in the use of Elastic compression stockings [ Time Frame: 9 years ]
    Compliance in the use of Elastic compression stockings

  7. Risk factors [ Time Frame: 9 years ]
    Risk factors for venous thromboembolism

  8. Resource utilization [ Time Frame: 9 years ]
    Resource utilization (number of contacts with health care providers, INR tests during anticoagulation)

  9. Post thrombotic syndrome according to CEAP [ Time Frame: 9 years ]
    PTS according to CEAP score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with VTE in Østfold who fulfil study criteria will be invited to participate.
Criteria

Inclusion Criteria:

  • Patients with objectively verified first time DVT diagnosed after 01.01.11 for study A, OR objectively verified DVT and/or PE dignosed after 01.04.14 for study B.

    • 18 years of age
  • Signed informed written consent

Exclusion Criteria:

  • Patients who refuse to consent
  • Patients who have been treated with other anticoagulants than thoose included in the study
  • Patients who can not participate due to logistic reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268630


Contacts
Contact: Kristin K Utne, MD 004790417184 kristin.utne@gmail.com
Contact: Waleed Ghanima, PhD 004741303440 wghanima@gmail.com

Locations
Norway
Akershus University Hospital Recruiting
Lørenskog, Akershus, Norway, 1478
Ostfold Hospital Trust Recruiting
Fredrikstad, Ostfold, Norway, 1606
Principal Investigator: Kristin K Utne, MD         
Ullevål University Hospital Not yet recruiting
Oslo, Norway, 0450
Sponsors and Collaborators
Ostfold Hospital Trust
Investigators
Principal Investigator: Kristin K Utne, MD Ostfold Hospital Trust
Study Director: Waleed Ghanima, PhD Ostfold Hospital Trust

Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT02268630     History of Changes
Other Study ID Numbers: LOVE1213
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

Keywords provided by Ostfold Hospital Trust:
Post-thrombotic syndrome
Chronic thromboembolic pulmonary hypertension
Anticoagulation
Rivaroxaban

Additional relevant MeSH terms:
Hypertension
Thrombosis
Hypertension, Pulmonary
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants