Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events (GARFIELD-VTE)

May 4, 2021 updated by: Thrombosis Research Institute

Global Anticoagulant Registry in the Field Observing Treatment and Outcomes in Patients With Treated Acute Venous Thromboembolic Events in the Real World

The protocol is a large registry to describe acute, sub-acute and extended duration of anticoagulation management, clinical and economic duration of anticoagulation management, clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the real-world setting.

Main objectives are to clarify the:

  • treatment related details for acute VTE (either conventional anticoagulation therapy, treatment with a direct oral anti-coagulant or other modalities of treatment)
  • Rate of early and late symptomatic VTE recurrence
  • Rate and nature of complications of VTE including post thrombotic syndrome and chronic thromboembolic pulmonary hypertension
  • Rate of bleeding complications
  • Rate of all-cause mortality at six months

Study Overview

Status

Completed

Conditions

Detailed Description

Other objectives are to clarify the additional outcomes of:

  • Stroke (Measured by number of incidences)
  • Transient Ischemic Attack (TIA) (Measured by number on incidences)
  • ST Elevated Myocardial Infarction (STEMI) (Measured by number of incidences)
  • Non-ST Elevated Myocardial Infraction (NSTEMI) (Measured by number of incidences)
  • Unstable Angina (Measured by number of incidences)
  • Quality of life and patient reported outcomes and costs associated with the management of VTE.

Study Type

Observational

Enrollment (Actual)

10679

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35662
        • Dr Terence Hart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sites will be selected at random from a representative list reflecting treatment patterns in each country. Consecutive male and female VTE patients at the randomly selected sited will be included in the registry if they meet the eligibility criteria.

Description

Inclusion Criteria:

  • Written informed consent
  • Age 18 years and over
  • Treated first time or recurrent DVT (lower or upper extremity), PE alone or overlapping DVT and PE confirmed by appropriate diagnostic methods (patients must be assessed for eligibility within 30 days of diagnosis)
  • Patients included with recurrent VTE must have completed treatment for the previous VTE episode

Exclusion Criteria:

  • Patients for whom long-term follow-up is not envisaged within the enrolling hospital or the associated primary care physician
  • Patients participating in an interventional study that dictates treatments, visit frequency, or diagnostic procedures
  • Patients with only superficial vein thrombosis (SVT)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Prospective cohort 1
In order to observe temporal trends in management of VTE a first cohort of 5000 consecutive unselected patients treated for acute VTE will be recruited. This cohort will take approximately 9 months to recruit. Potential patients must be assessed for eligibility within 30 days of their acute VTE diagnosis. They will be followed prospectively for 36 months.
Prospective cohort 2
In order to observe temporal trends in management of VTE a second cohort of 5000 consecutive unselected patients treated for acute VTE will be recruited. Recruitment into the second cohort will commence when recruitment is completed in the first cohort. This cohort will take approximately 9 months to recruit. Potential patients must be assessed for eligibility within 30 days of their acute VTE diagnosis. They will be followed prospectively for 36 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)
Time Frame: 36 months
Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)
36 months
Bleeding events
Time Frame: 36 months
Frequency, location, severity (classified as major or non-major)
36 months
Hospitalization
Time Frame: 36 months
Measured by number of occurrences.
36 months
Post Thrombotic Syndrome
Time Frame: 36 months
Measured by number of occurrences and severity.
36 months
Chronic thromboembolic pulmonary hypertension
Time Frame: 36 months
Measured by number of occurrences and severity.
36 months
IVC filter placement
Time Frame: 36 months
Measured by number of occurrences.
36 months
Other urgent interventions for VTE
Time Frame: 36 months
Measured by number of occurrences.
36 months
Anticoagulation therapy persistence
Time Frame: 36 months
Estimation of Anticoagulation therapy will be compared to actual total time Anticoagulation therapy was used by patients.
36 months
All cause of mortality
Time Frame: 36 months
Causes of death: PE, stroke, cardiac, cancer-related, other...
36 months
International Normalized Ratio (INR) Values in Patients treated with Vitamin K Antagonists
Time Frame: 36 months
Will be assessed by frequency of INR monitoring, and number of INR readings taken before patient achieved optimum range.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke
Time Frame: 36 months
Ischemic stroke, hemorrhagic stroke
36 months
Trans Ischemic Attack (TIA)
Time Frame: 36 months
Measured by number of occurrences.
36 months
Myocardial Infarction
Time Frame: 36 months
Measured by number of occurrences of both ST-Elevated Myocardial Infarction and Non-ST Elevated Myocardial Infarction (STEMI/NSTEMI).
36 months
Unstable angina
Time Frame: 36 months
Measured by number of occurrences.
36 months
Quality of life and patient treatment satisfaction over a three year period
Time Frame: 36 months
Measured by Questionnaire.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thrombosis Research Institute

Collaborators

Bayer

Investigators

  • Study Director: Ajay K Kakkar, MD, Thrombosis Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2014

Primary Completion (Actual)

January 4, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 4, 2014

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRI08889

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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