Long Term Outcomes of Venous Thromboembolism | NCT02268630

Studies
Long Term Outcomes of Venous Thromboembolism

NCT02268630

Sponsor

Ostfold Hospital Trust

Status

Unknown status

Last Update Posted

Feb 16, 2017Actual

Enrollment

460Estimated

Phase

Not provided

Conditions

Post Thrombotic Syndrome
Chronic Thromboembolic Pulmonary Hypertension
Venous Thrombosis

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Oct 2023Estimated

Completion Date

Oct 2023Estimated

First Submitted Date

Aug 6, 2014

First Submission Date that Met QC Criteria

Oct 15, 2014

First Posted Date

Oct 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2017

Last Update Posted Date

Feb 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

460Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Patients treated with Warfarin for VTE
Grup B		Patients treated with Rivaroxaban for VTE

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of post thrombotic syndrome and chronic thromboembolic pulmonary hypertension	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.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Bleeding	Rate of bleeding during treatment with anticoagulation	9 years
Recurrence rate	Recurrence rate during treatment and after discontinuation of anticoagulation.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with VTE in Østfold who fulfil study criteria will be invited to participate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kristin K Utne, MD	Contact	004790417184		kristin.utne@gmail.com
Waleed Ghanima, PhD	Contact	004741303440		wghanima@gmail.com

Overall Officials

Name	Affiliation	Role
Kristin K Utne, MD	Ostfold Hospital Trust	Principal Investigator
Waleed Ghanima, PhD	Ostfold Hospital Trust	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akershus University Hospital	Recruiting	Lørenskog	Akershus	1478	Norway
Ullevål University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D054070	Postthrombotic Syndrome
D020246	Venous Thrombosis

Ancestor Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

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