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Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism

NCT03404635 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1300

Last updated 2020-08-07

No results posted yet for this study

Summary

Prospective, multicenter observational study, of the effectiveness of a standard of care protocol implemented to enhance home treatment of VTE. Study population will be selected as part of usual care as eligible for home treatment. Study personnel will travel to participating institutions to qualify the sites, deliver a Powerpoint® lecture to introduce the protocol, meet and train site principal investigators, emergency physicians and research personnel on the implementation of the protocol as part of usual clinical care, and data collection methods for a quality assurance registry with plans to use the data collected in this registry in future publications. Follow-up will be 30 days using medical records and/or telephone interview to assess for primary outcomes of bleeding or VTE recurrence.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Apixaban

Apixaban as standard of care for VTE

DRUG

Rivaroxaban

Rivaroxaban as standard of care for VTE

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-04
Primary Completion
2020-05-08
Completion
2020-05-08

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03404635 on ClinicalTrials.gov