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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thrombosis Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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