Registry of Patients Prescribed Anticoagulation

NCT03504007 | Recruiting

• 1 other identifier: 13-001404
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Acute Deep Vein Thrombosis; Acute Pulmonary Embolism

Keywords

Deep Vein Thrombosis; Pulmonary Embolism; Apixaban; Rivaroxaban; Dabigatran; Edoxaban

Outcome Measures

Primary Outcomes (1)

• Incidence of symptomatic, recurrent VTE. Incidence of major bleeding

  Recurrent VTE clearly new compared to previous VTE. Major bleeding by ISTH definition

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• VTE seen at Thrombophilia Clinic and treatment with anti-coagulant is started within 14 days of VTE diagnosis date.

You may not qualify if:

• Patients already on anticoagulation for other reasons or enrolled into anticoagulation clinical trials.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 29217335 BACKGROUND

• Bott-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.

  PMID: 26797081 BACKGROUND

• Houghton 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.

  PMID: 34425962 BACKGROUND

• Wysokinski 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.

  PMID: 32557773 BACKGROUND

• Houghton 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.

  PMID: 32267011 BACKGROUND

• Hirao-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.

  PMID: 34993715 DERIVED

• Cambron 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.

  PMID: 32542216 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Damon Houghton, MD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damon Houghton, MD, MS

CONTACT

507-266-6717; vteregistry@mayo.edu

Danielle Vlazny, P.A.-C., M.S.

CONTACT

507-266-6717; vteregistry@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: March 1, 2013
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2033
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)