Registry of Patients Prescribed Anticoagulation (STAGPOR)

April 22, 2026 updated by: Damon E. Houghton, Mayo Clinic

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Damon Houghton, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Damon Houghton, MD, MS, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2033

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-001404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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