Venous ThromboembolismGARFIELD-VTENCT02155491
Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events
An observational study of Venous Thromboembolism and Deep Vein Thrombosis, run by Thrombosis Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
- How many people
- 10,679 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2014to 30 Sep 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Global Anticoagulant Registry in the Field Observing Treatment and Outcomes in Patients With Treated Acute Venous Thromboembolic Events in the Real World
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
Read the 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.
- Keywords
- venous, thromboembolism, embolism, DVT, Pulmonary Embolism, thrombosis
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Thromboembolism, Embolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)
Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)
Measured: 36 months
Bleeding events
Frequency, location, severity (classified as major or non-major)
Measured: 36 months
Hospitalization
Measured by number of occurrences.
Measured: 36 months
Post Thrombotic Syndrome
Measured by number of occurrences and severity.
Measured: 36 months
Chronic thromboembolic pulmonary hypertension
Measured by number of occurrences and severity.
Measured: 36 months
IVC filter placement
Measured by number of occurrences.
Measured: 36 months
Other urgent interventions for VTE
Measured by number of occurrences.
Measured: 36 months
Anticoagulation therapy persistence
Estimation of Anticoagulation therapy will be compared to actual total time Anticoagulation therapy was used by patients.
Measured: 36 months
All cause of mortality
Causes of death: PE, stroke, cardiac, cancer-related, other...
Measured: 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.
Measured: 36 months
Secondary outcomes (5)
Stroke
Ischemic stroke, hemorrhagic stroke
Measured: 36 months
Trans Ischemic Attack (TIA)
Measured by number of occurrences.
Measured: 36 months
Myocardial Infarction
Measured by number of occurrences of both ST-Elevated Myocardial Infarction and Non-ST Elevated Myocardial Infarction (STEMI/NSTEMI).
Measured: 36 months
Unstable angina
Measured by number of occurrences.
Measured: 36 months
Quality of life and patient treatment satisfaction over a three year period
Measured by Questionnaire.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study start7 Jul 2014
- Primary completion4 Jan 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,679 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Thrombosis Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Ajay K Kakkar, MD, Study director, Thrombosis Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155491
- Sponsor's protocol ID
- TRI08889
- Acronym
- GARFIELD-VTE
- Status last verified
- May 2021
- First submitted
- 30 Apr 2014
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18296591Cohen 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.
PubMed 17938798Eurostat, Eurostat statistics on health and safety 2001.
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.
PubMed 9521222Prandoni 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.
PubMed 17296569Kahn 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.
PubMed 14718318Prandoni 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.
PubMed 19222476Leizorovicz A. Long-term consequences of deep vein thrombosis. Haemostasis. 1998;28 Suppl 3:1-7. doi: 10.1159/000022399.
PubMed 10069756Prandoni 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.
PubMed 9666534Ruppert 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.
PubMed 21222564MacDougall 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.
PubMed 17032933Pengo 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.
PubMed 15163775Hyers 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.
PubMed 11157648McRae 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.
PubMed 15339875Kearon 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.
PubMed 22315268
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Anticoagulant Registry in the Field Observing Treatment and Outcomes in Patients With Treated Acute Venous Thromboembolic Events in the Real World
- ClinicalTrials.gov ID
- NCT02155491
- Acronym / sponsor ID
- GARFIELD-VTE / TRI08889
- Keywords
- venous, thromboembolism, embolism, DVT, Pulmonary Embolism, thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,679 participants (actual)
- Lead sponsor
- Thrombosis Research InstituteUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 7 Jul 2014 (actual)
- Primary completion
- 4 Jan 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Bleeding events
Time frame: 36 months
Frequency, location, severity (classified as major or non-major)
Hospitalization
Time frame: 36 months
Measured by number of occurrences.
Post Thrombotic Syndrome
Time frame: 36 months
Measured by number of occurrences and severity.
Chronic thromboembolic pulmonary hypertension
Time frame: 36 months
Measured by number of occurrences and severity.
IVC filter placement
Time frame: 36 months
Measured by number of occurrences.
Other urgent interventions for VTE
Time frame: 36 months
Measured by number of occurrences.
Anticoagulation therapy persistence
Time frame: 36 months
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
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
Will be assessed by frequency of INR monitoring, and number of INR readings taken before patient achieved optimum range.
5 secondary outcomes
Stroke
Time frame: 36 months
Trans Ischemic Attack (TIA)
Time frame: 36 months
Myocardial Infarction
Time frame: 36 months
Unstable angina
Time frame: 36 months
Quality of life and patient treatment satisfaction over a three year period
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Background: PubMed 18296591Heit 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.
- Background: PubMed 17938798Cohen 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.
- BackgroundEurostat, Eurostat statistics on health and safety 2001.
- Background: PubMed 9521222Silverstein 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.
- Background: PubMed 17296569Prandoni 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.
- Background: PubMed 14718318Kahn 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.
- Background: PubMed 19222476Prandoni 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.
- Background: PubMed 10069756Leizorovicz A. Long-term consequences of deep vein thrombosis. Haemostasis. 1998;28 Suppl 3:1-7. doi: 10.1159/000022399.
- Background: PubMed 9666534Prandoni 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.
- Background: PubMed 21222564Ruppert 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.
- Background: PubMed 17032933MacDougall 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.
- Background: PubMed 15163775Pengo 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.
- Global Anticoagulant Registry in the FIELD, Venous thromboembolism Event (GARFIELD-VTE)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay K Kakkar, MD study director
Thrombosis Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Deep Vein Thrombosis, run by Thrombosis Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE) (time frame: 36 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02155491, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.