Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events

NCT02155491 | Completed DMC

• 1 other identifier: TRI08889
• Study Type: observational
• Target: 10,679
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism

Keywords

venous, thromboembolism, embolism, DVT, Pulmonary Embolism, thrombosis

Outcome Measures

Primary Outcomes (10)

• Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)

  Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)

  36 months

• Bleeding events

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

  36 months

• Hospitalization

  Measured by number of occurrences.

  36 months

• Post Thrombotic Syndrome

  Measured by number of occurrences and severity.

  36 months

• Chronic thromboembolic pulmonary hypertension

  Measured by number of occurrences and severity.

  36 months

• IVC filter placement

  Measured by number of occurrences.

  36 months

• Other urgent interventions for VTE

  Measured by number of occurrences.

  36 months

• Anticoagulation therapy persistence

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

  36 months

• All cause of mortality

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

  36 months

• International Normalized Ratio (INR) Values in Patients treated with Vitamin K Antagonists

  Will be assessed by frequency of INR monitoring, and number of INR readings taken before patient achieved optimum range.

  36 months

Secondary Outcomes (5)

• Stroke

  36 months

• Trans Ischemic Attack (TIA)

  36 months

• Myocardial Infarction

  36 months

• Unstable angina

  36 months

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

  36 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thrombosis Research Institute: lead
• Bayer: collaborator

Study Sites (1)

Dr Terence Hart

Muscle Shoals, Alabama, 35662, United States

Location

Related Publications (20)

• Heit JA. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):370-2. doi: 10.1161/ATVBAHA.108.162545. No abstract available.

  PMID: 18296591 BACKGROUND

• Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007 Oct;98(4):756-64. doi: 10.1160/TH07-03-0212.

  PMID: 17938798 BACKGROUND

• Eurostat, Eurostat statistics on health and safety 2001.

  BACKGROUND

• Silverstein MD, Heit JA, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med. 1998 Mar 23;158(6):585-93. doi: 10.1001/archinte.158.6.585.

  PMID: 9521222 BACKGROUND

• Prandoni P, Noventa F, Ghirarduzzi A, Pengo V, Bernardi E, Pesavento R, Iotti M, Tormene D, Simioni P, Pagnan A. The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients. Haematologica. 2007 Feb;92(2):199-205. doi: 10.3324/haematol.10516.

  PMID: 17296569 BACKGROUND

• Kahn SR, Ginsberg JS. Relationship between deep venous thrombosis and the postthrombotic syndrome. Arch Intern Med. 2004 Jan 12;164(1):17-26. doi: 10.1001/archinte.164.1.17.

  PMID: 14718318 BACKGROUND

• Prandoni P, Kahn SR. Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol. 2009 May;145(3):286-95. doi: 10.1111/j.1365-2141.2009.07601.x. Epub 2009 Feb 13.

  PMID: 19222476 BACKGROUND

• Leizorovicz A. Long-term consequences of deep vein thrombosis. Haemostasis. 1998;28 Suppl 3:1-7. doi: 10.1159/000022399.

  PMID: 10069756 BACKGROUND

• Prandoni P, Lensing AW, Prins MR. Long-term outcomes after deep venous thrombosis of the lower extremities. Vasc Med. 1998;3(1):57-60. doi: 10.1177/1358836X9800300112.

  PMID: 9666534 BACKGROUND

• Ruppert A, Steinle T, Lees M. Economic burden of venous thromboembolism: a systematic review. J Med Econ. 2011;14(1):65-74. doi: 10.3111/13696998.2010.546465. Epub 2011 Jan 12.

  PMID: 21222564 BACKGROUND

• MacDougall DA, Feliu AL, Boccuzzi SJ, Lin J. Economic burden of deep-vein thrombosis, pulmonary embolism, and post-thrombotic syndrome. Am J Health Syst Pharm. 2006 Oct 15;63(20 Suppl 6):S5-15. doi: 10.2146/ajhp060388.

  PMID: 17032933 BACKGROUND

• Pengo V, Lensing AW, Prins MH, Marchiori A, Davidson BL, Tiozzo F, Albanese P, Biasiolo A, Pegoraro C, Iliceto S, Prandoni P; Thromboembolic Pulmonary Hypertension Study Group. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med. 2004 May 27;350(22):2257-64. doi: 10.1056/NEJMoa032274.

  PMID: 15163775 BACKGROUND

• Hyers TM, Agnelli G, Hull RD, Morris TA, Samama M, Tapson V, Weg JG. Antithrombotic therapy for venous thromboembolic disease. Chest. 2001 Jan;119(1 Suppl):176S-193S. doi: 10.1378/chest.119.1_suppl.176s. No abstract available.

  PMID: 11157648 BACKGROUND

• McRae SJ, Ginsberg JS. Initial treatment of venous thromboembolism. Circulation. 2004 Aug 31;110(9 Suppl 1):I3-9. doi: 10.1161/01.CIR.0000140904.52752.0c.

  PMID: 15339875 BACKGROUND

• Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e419S-e496S. doi: 10.1378/chest.11-2301.

  PMID: 22315268 BACKGROUND

• Adcock, D.M., Recurrence of thromboembolism: determining risk. Clinical Haemostasis Review. 2005. 19:1.

  BACKGROUND

• Spyropoulos AC, Lin J. Direct medical costs of venous thromboembolism and subsequent hospital readmission rates: an administrative claims analysis from 30 managed care organizations. J Manag Care Pharm. 2007 Jul-Aug;13(6):475-86. doi: 10.18553/jmcp.2007.13.6.475.

  PMID: 17672809 BACKGROUND

• Summary of Recommendation Statements. Kidney Int Suppl (2011). 2013 Jan;3(1):5-14. doi: 10.1038/kisup.2012.77. No abstract available.

  PMID: 25598998 BACKGROUND

• Goto S, Turpie AGG, Farjat AE, Weitz JI, Haas S, Ageno W, Goldhaber SZ, Angchaisuksiri P, Kayani G, MacCallum P, Schellong S, Bounameaux H, Mantovani LG, Prandoni P, Kakkar AK; GARFIELD-VTE investigators. The influence of anemia on clinical outcomes in venous thromboembolism: Results from GARFIELD-VTE. Thromb Res. 2021 Jul;203:155-162. doi: 10.1016/j.thromres.2021.05.007. Epub 2021 May 15.

  PMID: 34023735 DERIVED

• Weitz JI, Haas S, Ageno W, Goldhaber SZ, Turpie AGG, Goto S, Angchaisuksiri P, Nielsen JD, Kayani G, Farjat AE, Schellong S, Bounameaux H, Mantovani LG, Prandoni P, Kakkar AK; GARFIELD-VTE investigators. Cancer associated thrombosis in everyday practice: perspectives from GARFIELD-VTE. J Thromb Thrombolysis. 2020 Aug;50(2):267-277. doi: 10.1007/s11239-020-02180-x.

  PMID: 32583306 DERIVED

Related Links

• Global Anticoagulant Registry in the FIELD, Venous thromboembolism Event (GARFIELD-VTE)

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism; Thromboembolism; Embolism; Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ajay K Kakkar, MD

  Thrombosis Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: June 4, 2014
• Study Start: July 7, 2014
• Primary Completion: January 4, 2020
• Study Completion: September 30, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)