Muscle Shoals, Alabama 35662

  • Pulmonary Embolism

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


Study summary:

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.


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)


Study is Available At:


Original ID:

TRI08889


NCT ID:

NCT02155491


Secondary ID:


Study Acronym:

GARFIELD-VTE


Brief Title:

Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

99 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Thrombosis Research Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational [Patient Registry]


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

10679


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ajay K Kakkar, MD
Study Director
Thrombosis Research Institute

Study Dates

Start Date:July 7, 2014
Completion Date:September 30, 2020
Completion Type:Actual
Primary Completion Date:January 4, 2020
Primary Completion Type:Actual
Verification Date:May 2021
Last Changed Date:May 4, 2021
First Received Date:April 30, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)
Time Frame:36 months
Safety Issues:False
Description:Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)
Outcome Type:Primary Outcome
Measure:Bleeding events
Time Frame:36 months
Safety Issues:False
Description:Frequency, location, severity (classified as major or non-major)
Outcome Type:Primary Outcome
Measure:Hospitalization
Time Frame:36 months
Safety Issues:False
Description:Measured by number of occurrences.
Outcome Type:Primary Outcome
Measure:Post Thrombotic Syndrome
Time Frame:36 months
Safety Issues:False
Description:Measured by number of occurrences and severity.
Outcome Type:Primary Outcome
Measure:Chronic thromboembolic pulmonary hypertension
Time Frame:36 months
Safety Issues:False
Description:Measured by number of occurrences and severity.
Outcome Type:Primary Outcome
Measure:IVC filter placement
Time Frame:36 months
Safety Issues:False
Description:Measured by number of occurrences.
Outcome Type:Primary Outcome
Measure:Other urgent interventions for VTE
Time Frame:36 months
Safety Issues:False
Description:Measured by number of occurrences.
Outcome Type:Primary Outcome
Measure:Anticoagulation therapy persistence
Time Frame:36 months
Safety Issues:False
Description:Estimation of Anticoagulation therapy will be compared to actual total time Anticoagulation therapy was used by patients.
Outcome Type:Primary Outcome
Measure:All cause of mortality
Time Frame:36 months
Safety Issues:False
Description:Causes of death: PE, stroke, cardiac, cancer-related, other...
Outcome Type:Primary Outcome
Measure:International Normalized Ratio (INR) Values in Patients treated with Vitamin K Antagonists
Time Frame:36 months
Safety Issues:False
Description:Will be assessed by frequency of INR monitoring, and number of INR readings taken before patient achieved optimum range.
Outcome Type:Secondary Outcome
Measure:Stroke
Time Frame:36 months
Safety Issues:False
Description:Ischemic stroke, hemorrhagic stroke
Outcome Type:Secondary Outcome
Measure:Trans Ischemic Attack (TIA)
Time Frame:36 months
Safety Issues:False
Description:Measured by number of occurrences.
Outcome Type:Secondary Outcome
Measure:Myocardial Infarction
Time Frame:36 months
Safety Issues:False
Description:Measured by number of occurrences of both ST-Elevated Myocardial Infarction and Non-ST Elevated Myocardial Infarction (STEMI/NSTEMI).
Outcome Type:Secondary Outcome
Measure:Unstable angina
Time Frame:36 months
Safety Issues:False
Description:Measured by number of occurrences.
Outcome Type:Secondary Outcome
Measure:Quality of life and patient treatment satisfaction over a three year period
Time Frame:36 months
Safety Issues:False
Description:Measured by Questionnaire.

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Prospective cohort 2
Description: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.
Study Arm Type:Other
Arm Name:Prospective cohort 1
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Thrombosis Research Institute
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Bayer

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation:KDIGO, Summary of recommendation statements. Kidney Int, 2013. 3 (Suppl):5.
Reference Type:Reference
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.
PMID:17672809
Reference Type:Reference
Citation:Adcock, D.M., Recurrence of thromboembolism: determining risk. Clinical Haemostasis Review. 2005. 19:1.
Reference Type:Reference
Citation: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.
PMID:22315268
Reference Type:Reference
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.
PMID:15339875
Reference Type:Reference
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.
PMID:11157648
Reference Type:Reference
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.
PMID:15163775
Reference Type:Reference
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.
PMID:17032933
Reference Type:Reference
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.
PMID:21222564
Reference Type:Reference
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.
PMID:9666534
Reference Type:Reference
Citation:Leizorovicz A. Long-term consequences of deep vein thrombosis. Haemostasis. 1998;28 Suppl 3:1-7. Review.
PMID:10069756
Reference Type:Reference
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.
PMID:19222476
Reference Type:Reference
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.
PMID:14718318
Reference Type:Reference
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.
PMID:17296569
Reference Type:Reference
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.
PMID:9521222
Reference Type:Reference
Citation:Eurostat, Eurostat statistics on health and safety 2001.
Reference Type:Reference
Citation: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.
PMID:17938798
Reference Type:Reference
Citation: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.
PMID:18296591

Data Source: ClinicalTrials.gov

Date Processed: August 07, 2022

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