Clinical trial NCT02268630: Long Term Outcomes of Venous Thromboembolism
Official title: Long Term Outcomes of Venous Thromboembolism -the LOVE Study-
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Thrombotic Syndrome
Chronic Thromboembolic Pulmonary Hypertension
Venous Thrombosis
Keywords: Post-thrombotic syndrome
Chronic thromboembolic pulmonary hypertension
Anticoagulation
Rivaroxaban
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with VTE in Østfold who fulfil study criteria will be invited to participate.

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.

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of post thrombotic syndrome and chronic thromboembolic pulmonary hypertension
timeFrame: 5 years
Secondary outcomes:
measure: Bleeding
timeFrame: 9 years
measure: Recurrence rate
timeFrame: 9 years
measure: Mortality rate
timeFrame: 9 years
measure: Severity of pulmonary embolism
timeFrame: 9 years
measure: Incidence of cancer
timeFrame: 9 years
measure: Compliance in the use of Elastic compression stockings
timeFrame: 9 years
measure: Risk factors
timeFrame: 9 years
measure: Resource utilization
timeFrame: 9 years
measure: Post thrombotic syndrome according to CEAP
timeFrame: 9 years
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
city: Fredrikstad
country: Norway
facility: Ostfold Hospital Trust
state: Ostfold
city: Oslo
country: Norway
facility: Ullevål University Hospital
Study officials:
affiliation: Ostfold Hospital Trust
name: Kristin K Utne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ostfold Hospital Trust
name: Waleed Ghanima, PhD
role: STUDY_DIRECTOR
References: