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Completed

NCT Number: NCT02155491

Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events

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

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Deep Vein Thrombosis Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Terence Hart

Muscle Shoals, Alabama, 35662, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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)

  2. Bleeding events

    Time frame: 36 months

    Frequency, location, severity (classified as major or non-major)

  3. Hospitalization

    Time frame: 36 months

    Measured by number of occurrences.

  4. Post Thrombotic Syndrome

    Time frame: 36 months

    Measured by number of occurrences and severity.

  5. Chronic thromboembolic pulmonary hypertension

    Time frame: 36 months

    Measured by number of occurrences and severity.

  6. IVC filter placement

    Time frame: 36 months

    Measured by number of occurrences.

  7. Other urgent interventions for VTE

    Time frame: 36 months

    Measured by number of occurrences.

  8. Anticoagulation therapy persistence

    Time frame: 36 months

    Estimation of Anticoagulation therapy will be compared to actual total time Anticoagulation therapy was used by patients.

  9. All cause of mortality

    Time frame: 36 months

    Causes of death: PE, stroke, cardiac, cancer-related, other...

  10. 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.

Secondary outcomes

  1. Stroke

    Time frame: 36 months

    Ischemic stroke, hemorrhagic stroke

  2. Trans Ischemic Attack (TIA)

    Time frame: 36 months

    Measured by number of occurrences.

  3. 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).

  4. Unstable angina

    Time frame: 36 months

    Measured by number of occurrences.

  5. Quality of life and patient treatment satisfaction over a three year period

    Time frame: 36 months

    Measured by Questionnaire.

Sponsors and collaborators

Lead sponsor

Thrombosis Research Institute

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Acronym: GARFIELD-VTE

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2014
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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