Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Thrombosis Research Institute
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Thrombosis Research Institute
ClinicalTrials.gov Identifier:
NCT02155491
First received: April 30, 2014
Last updated: December 10, 2014
Last verified: December 2014
  Purpose

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

Condition
Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Global Anticoagulant Registry in the Field Observing Treatment and Outcomes in Patients With Treated Acute Venous Thromboembolic Events in the Real World

Resource links provided by NLM:


Further study details as provided by Thrombosis Research Institute:

Primary Outcome Measures:
  • Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Bleeding events [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Frequency, location, severity (classified as major or non-major)

  • Hospitalization [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measured by number of occurrences.

  • Post Thrombotic Syndrome [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measured by number of occurrences and severity.

  • Chronic thromboembolic pulmonary hypertension [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measured by number of occurrences and severity.

  • IVC filter placement [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measured by number of occurrences.

  • Other urgent interventions for VTE [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measured by number of occurrences.

  • Anticoagulation therapy persistence [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Estimation of Anticoagulation therapy will be compared to actual total time Anticoagulation therapy was used by patients.

  • All cause of mortality [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Causes of death: PE, stroke, cardiac, cancer-related, other...

  • International Normalized Ratio (INR) Values in Patients treated with Vitamin K Antagonists [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Will be assessed by frequency of INR monitoring, and number of INR readings taken before patient achieved optimum range.


Secondary Outcome Measures:
  • Stroke [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Ischemic stroke, hemorrhagic stroke

  • Trans Ischemic Attack (TIA) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measured by number of occurrences.

  • Myocardial Infarction [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measured by number of occurrences of both ST-Elevated Myocardial Infarction and Non-ST Elevated Myocardial Infarction (STEMI/NSTEMI).

  • Unstable angina [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measured by number of occurrences.

  • Quality of life and patient treatment satisfaction over a three year period [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measured by Questionnaire.


Estimated Enrollment: 10000
Study Start Date: March 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02155491

Contacts
Contact: Glorya Kayani gkayani@tri-london.ac.uk
Contact: Ravi Shukla rshukla@tri-london.ac.uk

Locations
United States, Alabama
Dr Terence Hart Recruiting
Muscle Shoals, Alabama, United States, 35662
Contact: Andrea Davis, RN    256-386-1105      
Contact: Alice Arnold    2567102923      
Sponsors and Collaborators
Thrombosis Research Institute
Bayer
Investigators
Study Director: Ajay K Kakkar, MD Thrombosis Research Institute
  More Information

Additional Information:
Publications:
Kearon, C., et al., Antithrombotic therapy for vte disease: Antithrombotic therapy and prevention of thrombosis, 9th ed: american college of chest physicians evidence-based clinical practice guidelines. CHEST Journal, 2012. 141(2_suppl): p. e419S-e494S.

Responsible Party: Thrombosis Research Institute
ClinicalTrials.gov Identifier: NCT02155491     History of Changes
Other Study ID Numbers: TRI08889
Study First Received: April 30, 2014
Last Updated: December 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thrombosis Research Institute:
venous, thromboembolism, embolism, DVT, Pulmonary Embolism, thrombosis

Additional relevant MeSH terms:
Pulmonary Embolism
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015