Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events

Pulmonary Embolism Clinical Trial

— GARFIELD-VTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155491
• Other study ID #: TRI08889
• Status: Completed
• Start date: July 7, 2014
• Est. completion date: September 30, 2020

Study information

• Verified date: May 2021
• Source: Thrombosis Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10679
• Est. completion date: September 30, 2020
• Est. primary completion date: January 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
United States	Dr Terence Hart	Muscle Shoals	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Thrombosis Research Institute	Bayer

Country where clinical trial is conducted

United States, 

References & Publications (18)

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

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. — View Citation

Eurostat, Eurostat statistics on health and safety 2001.

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. Review. — View Citation

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. Review. — View Citation

Kahn SR, Ginsberg JS. Relationship between deep venous thrombosis and the postthrombotic syndrome. Arch Intern Med. 2004 Jan 12;164(1):17-26. Review. — View Citation

KDIGO, Summary of recommendation statements. Kidney Int, 2013. 3 (Suppl):5.

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. Erratum in: Chest. 2012 Dec;142(6):1698-1704. — View Citation

Leizorovicz A. Long-term consequences of deep vein thrombosis. Haemostasis. 1998;28 Suppl 3:1-7. Review. — View Citation

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. — View Citation

McRae SJ, Ginsberg JS. Initial treatment of venous thromboembolism. Circulation. 2004 Aug 31;110(9 Suppl 1):I3-9. Review. Erratum in: Circulation. 2004 Dec 14;110(24 Suppl 1):IV33. Circulation. 2005 Jan 25;111(3):378. — View Citation

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. — View Citation

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. Review. — View Citation

Prandoni P, Lensing AW, Prins MR. Long-term outcomes after deep venous thrombosis of the lower extremities. Vasc Med. 1998;3(1):57-60. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Bleeding events	Frequency, location, severity (classified as major or non-major)	36 months
Primary	Hospitalization	Measured by number of occurrences.	36 months
Primary	Post Thrombotic Syndrome	Measured by number of occurrences and severity.	36 months
Primary	Chronic thromboembolic pulmonary hypertension	Measured by number of occurrences and severity.	36 months
Primary	IVC filter placement	Measured by number of occurrences.	36 months
Primary	Other urgent interventions for VTE	Measured by number of occurrences.	36 months
Primary	Anticoagulation therapy persistence	Estimation of Anticoagulation therapy will be compared to actual total time Anticoagulation therapy was used by patients.	36 months
Primary	All cause of mortality	Causes of death: PE, stroke, cardiac, cancer-related, other...	36 months
Primary	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	Stroke	Ischemic stroke, hemorrhagic stroke	36 months
Secondary	Trans Ischemic Attack (TIA)	Measured by number of occurrences.	36 months
Secondary	Myocardial Infarction	Measured by number of occurrences of both ST-Elevated Myocardial Infarction and Non-ST Elevated Myocardial Infarction (STEMI/NSTEMI).	36 months
Secondary	Unstable angina	Measured by number of occurrences.	36 months
Secondary	Quality of life and patient treatment satisfaction over a three year period	Measured by Questionnaire.	36 months

External Links

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