Acute Deep Vein ThrombosisSTAGPORNCT03504007
Registry of Patients Prescribed Anticoagulation
An observational study of Acute Deep Vein Thrombosis and Acute Pulmonary Embolism, run by Mayo Clinic at 1 site in United States.
Trial summary
The Gonda Vascular Center- Thrombophilia Clinic at Mayo Clinic in Rochester, Minnesota utilizes a standardized, guideline-directed, yet patient-oriented approach for treating patients diagnosed with venous thromboembolism (VTE).This study is the ongoing registry of clinical practice with standardized approach to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Deep Vein Thrombosis, Acute Pulmonary Embolism
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2013to Mar 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mayo Clinic patients prescribed anticoagulation for treatment of acute DVT or PE. Treatment with all FDA-approved anticoagulants are captured in the database
Who may be able to join
- VTE seen at Thrombophilia Clinic and treatment with anti-coagulant is started within 14 days of VTE diagnosis date.
Who cannot join
- Patients already on anticoagulation for other reasons or enrolled into anticoagulation clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Damon Houghton, MD, MS, 507-266-6717, Houghton.Damon@mayo.edu
Damon Houghton, MD, MS
About this study
Official title: Standardized, Guidelines Directed But Patients Oriented Clinical Practice Prospectively Registered
The Gonda Vascular Center- Thrombophilia Clinic at Mayo Clinic in Rochester, Minnesota utilizes a standardized, guideline-directed, yet patient-oriented approach for treating patients diagnosed with venous thromboembolism (VTE).This study is the ongoing registry of clinical practice with standardized approach to patient assessment and therapy. As most of registries it does not have any definite number of recruited subjects or the date of study completion but provides anticipated number of recruited subjects and the time of anticipated enrolment which was provided only because of formal requirement related to structure of ClinicalTrials.gov website. This number will be updated and upgraded as we continue this registry.
The rates of VTE recurrence, major bleeding, clinically relevant non-major bleeding (CRNMB) and survival in patients treated with anticoagulation for acute VTE are assessed during prospective observation. VTE cases include an acute deep vein thrombosis (DVT) of lower or upper extremities, splanchnic veins, gonadal, renal, cerebral veins thrombosis and pulmonary embolism (PE). Therapy includes the whole spectrum of FDA approved anticoagulants such as "classic" agents: warfarin and heparinoids and the newer direct oral anticoagulants (DOACs) such as rivaroxaban, dabigatran, apixaban, and edoxaban.
Read the detailed description
When a patient has positive testing for acute VTE the radiologist interpreting the study contacts the Thrombophilia Center and the patient is immediately evaluated. Standardized information about guidelines endorsed anticoagulation therapy is provided in a uniform fashion with a standardized script for providers and a short summary table for the patient. This initial review also includes patient-specific cost information by contacting a pharmacy service phone-line. Patients with cancer-related VTE are counselled regarding the guideline endorsed use of low molecular heparin (LMWH) as the preferred option of anticoagulation and available data on DOACs. After the shared decision making is complete, the prescription is promptly filled at the pharmacy located within the same building, with the first dose administered within the ensuing hour. For patients with acute VTE diagnosed after hours, evaluation is accomplished in the Emergency Department; one dose of LMWH is administered and the patient is referred the next day to the Thrombophilia Clinic.
Patients with symptomatic PE or extensive symptomatic iliofemoral DVT are referred for prompt hospitalization. While in the hospital, they are consulted by a Vascular Medicine service and an appropriate follow up visit at the Thrombophilia Clinic is arranged. For patients with asymptomatic or minimally symptomatic pulmonary embolism (simplified Pulmonary Embolism Severity Index (PESI) score of 0), outpatient management is offered. All patients with cancer-associated PE are referred for lower extremity duplex ultrasound, and if symptomatic or if a central venous catheter is in place, also for upper extremity venous assessment.
Demographic and clinical data are entered into a REDCap. The registry is maintained on institutional servers, which are backed-up nightly and protected in controlled computer room with uninterrupted power supplies, data will never reside on a desktop computer system. Transfer of registry data will occur inside the Mayo Clinic firewall via our integrated high speed network. Analysis will be done using the most current version of SAS® software.
At the most recent update, over 2775 patients were enrolled. These data are used to analyze currently relevant clinical questions and are presented and published.
- Keywords
- Deep Vein Thrombosis, Pulmonary Embolism, Apixaban, Rivaroxaban, Dabigatran, Edoxaban
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic, recurrent VTE. Incidence of major bleeding
Recurrent VTE clearly new compared to previous VTE. Major bleeding by ISTH definition
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 Mar 2013
- Primary completionMar 2033 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damon E. Houghton, Mayo Clinic
- Investigators
- Damon Houghton, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504007
- Sponsor's protocol ID
- 13-001404
- Acronym
- STAGPOR
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2018
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janczak DT, Mimier MK, McBane RD, Kamath PS, Simmons BS, Bott-Kitslaar DM, Lenz CJ, Vargas ER, Hodge DO, Wysokinski WE. Rivaroxaban and Apixaban for Initial Treatment of Acute Venous Thromboembolism of Atypical Location. Mayo Clin Proc. 2018 Jan;93(1):40-47. doi: 10.1016/j.mayocp.2017.10.007. Epub 2017 Dec 6.
PubMed 29217335Bott-Kitslaar DM, Saadiq RA, McBane RD, Loprinzi CL, Ashrani AA, Ransone TR, Wolfgram AA, Berentsen MM, Wysokinski WE. Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy: A Single-Center Registry. Am J Med. 2016 Jun;129(6):615-9. doi: 10.1016/j.amjmed.2015.12.025. Epub 2016 Jan 18.
PubMed 26797081Houghton DE, Vlazny DT, Casanegra AI, Brunton N, Froehling DA, Meverden RA, Hodge DO, Peterson LG, McBane RD, Wysokinski WE. Bleeding in Patients With Gastrointestinal Cancer Compared With Nongastrointestinal Cancer Treated With Apixaban, Rivaroxaban, or Enoxaparin for Acute Venous Thromboembolism. Mayo Clin Proc. 2021 Nov;96(11):2793-2805. doi: 10.1016/j.mayocp.2021.04.026. Epub 2021 Aug 20.
PubMed 34425962Wysokinski WE, Froehling DA, Houghton DE, McBane RD, Vlazny DT, Bott-Kitslaar DM, Kuczmik W, Sutkowska K, Bator K, Hodge DO, Peterson LG, Casanegra AI. Effectiveness and safety of apixaban and rivaroxaban for acute venous thromboembolism therapy in patients with extremes in bodyweight. Eur J Haematol. 2020 Oct;105(4):484-494. doi: 10.1111/ejh.13471. Epub 2020 Jul 27.
PubMed 32557773Houghton DE, Casanegra AI, Peterson LG, Cochuyt J, Hodge DO, Vlazny D, McBane RD, Froehling D, Wysokinski WE. Treatment of upper extremity deep vein thrombosis with apixaban and rivaroxaban. Am J Hematol. 2020 Jul;95(7):817-823. doi: 10.1002/ajh.25820. Epub 2020 Apr 20.
PubMed 32267011Hirao-Try Y, Vlazny DT, Meverden R, Houghton DE, Casanegra AI, Froehling DA, Hodge DO, Peterson LG, McBane RD, Wysokinski WE. Single versus multiple and incidental versus symptomatic subsegmental pulmonary embolism: clinical characteristics and outcome. J Thromb Thrombolysis. 2022 Jul;54(1):82-90. doi: 10.1007/s11239-021-02623-z. Epub 2022 Jan 7.
PubMed 34993715Cambron JC, Saba ES, McBane RD, Casanegra AI, Villarraga HR, Houghton DE, Vlazny DT, Froehling D, Hodge D, Peterson LG, Bott-Kitslaar DM, Wysokinski WE. Adverse Events and Mortality in Anticoagulated Patients with Different Categories of Pulmonary Embolism. Mayo Clin Proc Innov Qual Outcomes. 2020 Jun 5;4(3):249-258. doi: 10.1016/j.mayocpiqo.2020.02.002. eCollection 2020 Jun.
PubMed 32542216
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized, Guidelines Directed But Patients Oriented Clinical Practice Prospectively Registered
- ClinicalTrials.gov ID
- NCT03504007
- Acronym / sponsor ID
- STAGPOR / 13-001404
- Keywords
- Deep Vein Thrombosis, Pulmonary Embolism, Apixaban, Rivaroxaban, Dabigatran, Edoxaban
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- Mar 2033 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 20 Apr 2018 (actual)
- 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 Gonda Vascular Center- Thrombophilia Clinic at Mayo Clinic in Rochester, Minnesota utilizes a standardized, guideline-directed, yet patient-oriented approach for treating patients diagnosed with venous thromboembolism (VTE).This study is the ongoing registry of clinical practice with standardized approach to patient assessment and therapy. As most of registries it does not have any definite number of recruited subjects or the date of study completion but provides anticipated number of recruited subjects and the time of anticipated enrolment which was provided only because of formal requirement related to structure of ClinicalTrials.gov website. This number will be updated and upgraded as we continue this registry.
The rates of VTE recurrence, major bleeding, clinically relevant non-major bleeding (CRNMB) and survival in patients treated with anticoagulation for acute VTE are assessed during prospective observation. VTE cases include an acute deep vein thrombosis (DVT) of lower or upper extremities, splanchnic veins, gonadal, renal, cerebral veins thrombosis and pulmonary embolism (PE). Therapy includes the whole spectrum of FDA approved anticoagulants such as "classic" agents: warfarin and heparinoids and the newer direct oral anticoagulants (DOACs) such as rivaroxaban, dabigatran, apixaban, and edoxaban.
Detailed description
When a patient has positive testing for acute VTE the radiologist interpreting the study contacts the Thrombophilia Center and the patient is immediately evaluated. Standardized information about guidelines endorsed anticoagulation therapy is provided in a uniform fashion with a standardized script for providers and a short summary table for the patient. This initial review also includes patient-specific cost information by contacting a pharmacy service phone-line. Patients with cancer-related VTE are counselled regarding the guideline endorsed use of low molecular heparin (LMWH) as the preferred option of anticoagulation and available data on DOACs. After the shared decision making is complete, the prescription is promptly filled at the pharmacy located within the same building, with the first dose administered within the ensuing hour. For patients with acute VTE diagnosed after hours, evaluation is accomplished in the Emergency Department; one dose of LMWH is administered and the patient is referred the next day to the Thrombophilia Clinic.
Patients with symptomatic PE or extensive symptomatic iliofemoral DVT are referred for prompt hospitalization. While in the hospital, they are consulted by a Vascular Medicine service and an appropriate follow up visit at the Thrombophilia Clinic is arranged. For patients with asymptomatic or minimally symptomatic pulmonary embolism (simplified Pulmonary Embolism Severity Index (PESI) score of 0), outpatient management is offered. All patients with cancer-associated PE are referred for lower extremity duplex ultrasound, and if symptomatic or if a central venous catheter is in place, also for upper extremity venous assessment.
Demographic and clinical data are entered into a REDCap. The registry is maintained on institutional servers, which are backed-up nightly and protected in controlled computer room with uninterrupted power supplies, data will never reside on a desktop computer system. Transfer of registry data will occur inside the Mayo Clinic firewall via our integrated high speed network. Analysis will be done using the most current version of SAS® software.
At the most recent update, over 2775 patients were enrolled. These data are used to analyze currently relevant clinical questions and are presented and published.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mayo Clinic patients prescribed anticoagulation for treatment of acute DVT or PE. Treatment with all FDA-approved anticoagulants are captured in the database
Key inclusion criteria (1 listed)
- VTE seen at Thrombophilia Clinic and treatment with anti-coagulant is started within 14 days of VTE diagnosis date.
Key exclusion criteria (1 listed)
- Patients already on anticoagulation for other reasons or enrolled into anticoagulation clinical trials.
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
Incidence of symptomatic, recurrent VTE. Incidence of major bleeding
Time frame: 10 years
Recurrent VTE clearly new compared to previous VTE. Major bleeding by ISTH definition
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 29217335Janczak DT, Mimier MK, McBane RD, Kamath PS, Simmons BS, Bott-Kitslaar DM, Lenz CJ, Vargas ER, Hodge DO, Wysokinski WE. Rivaroxaban and Apixaban for Initial Treatment of Acute Venous Thromboembolism of Atypical Location. Mayo Clin Proc. 2018 Jan;93(1):40-47. doi: 10.1016/j.mayocp.2017.10.007. Epub 2017 Dec 6.
- Background: PubMed 26797081Bott-Kitslaar DM, Saadiq RA, McBane RD, Loprinzi CL, Ashrani AA, Ransone TR, Wolfgram AA, Berentsen MM, Wysokinski WE. Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy: A Single-Center Registry. Am J Med. 2016 Jun;129(6):615-9. doi: 10.1016/j.amjmed.2015.12.025. Epub 2016 Jan 18.
- Background: PubMed 34425962Houghton DE, Vlazny DT, Casanegra AI, Brunton N, Froehling DA, Meverden RA, Hodge DO, Peterson LG, McBane RD, Wysokinski WE. Bleeding in Patients With Gastrointestinal Cancer Compared With Nongastrointestinal Cancer Treated With Apixaban, Rivaroxaban, or Enoxaparin for Acute Venous Thromboembolism. Mayo Clin Proc. 2021 Nov;96(11):2793-2805. doi: 10.1016/j.mayocp.2021.04.026. Epub 2021 Aug 20.
- Background: PubMed 32557773Wysokinski WE, Froehling DA, Houghton DE, McBane RD, Vlazny DT, Bott-Kitslaar DM, Kuczmik W, Sutkowska K, Bator K, Hodge DO, Peterson LG, Casanegra AI. Effectiveness and safety of apixaban and rivaroxaban for acute venous thromboembolism therapy in patients with extremes in bodyweight. Eur J Haematol. 2020 Oct;105(4):484-494. doi: 10.1111/ejh.13471. Epub 2020 Jul 27.
- Background: PubMed 32267011Houghton DE, Casanegra AI, Peterson LG, Cochuyt J, Hodge DO, Vlazny D, McBane RD, Froehling D, Wysokinski WE. Treatment of upper extremity deep vein thrombosis with apixaban and rivaroxaban. Am J Hematol. 2020 Jul;95(7):817-823. doi: 10.1002/ajh.25820. Epub 2020 Apr 20.
- Derived from this study: PubMed 34993715Hirao-Try Y, Vlazny DT, Meverden R, Houghton DE, Casanegra AI, Froehling DA, Hodge DO, Peterson LG, McBane RD, Wysokinski WE. Single versus multiple and incidental versus symptomatic subsegmental pulmonary embolism: clinical characteristics and outcome. J Thromb Thrombolysis. 2022 Jul;54(1):82-90. doi: 10.1007/s11239-021-02623-z. Epub 2022 Jan 7.
- Derived from this study: PubMed 32542216Cambron JC, Saba ES, McBane RD, Casanegra AI, Villarraga HR, Houghton DE, Vlazny DT, Froehling D, Hodge D, Peterson LG, Bott-Kitslaar DM, Wysokinski WE. Adverse Events and Mortality in Anticoagulated Patients with Different Categories of Pulmonary Embolism. Mayo Clin Proc Innov Qual Outcomes. 2020 Jun 5;4(3):249-258. doi: 10.1016/j.mayocpiqo.2020.02.002. eCollection 2020 Jun.
- Mayo Clinic Clinical TrialsLink 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.
Damon Houghton, MD, MS principal investigator
Mayo Clinic
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 Acute Deep Vein Thrombosis and Acute Pulmonary Embolism, run by Mayo Clinic 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damon Houghton, MD, MS (507-266-6717, vteregistry@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic, recurrent VTE. Incidence of major bleeding (time frame: 10 years). 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 NCT03504007, which also lists 7 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 27 Apr 2026.