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Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism (MATHVTE)

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ClinicalTrials.gov Identifier: NCT03404635
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Bristol-Myers Squibb
Information provided by (Responsible Party):
Indiana University

Brief 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.

Condition or disease Intervention/treatment
Venous Thromboembolism Drug: Apixaban

Study Type : Observational
Estimated Enrollment : 850 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monotherapy Anticoagulation To Expedite Home Treatment of Venous
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban
U.S. FDA Resources

Group/Cohort Intervention/treatment
Apixaban for VTE Drug: Apixaban
Apixaban as standard of care for VTE

Primary Outcome Measures :
  1. Number of re-hospitalization visits for VTE recurrence or bleeding [ Time Frame: 30 days ]
    Re-hospitalization for > 24 hours due to VTE recurrence or bleeding

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergency department patients with new or recurrent VTE deemed low-risk by modified Hestia or clinician discretion and sPESI (-).

Inclusion Criteria:

  1. Patients must be low risk, as defined by either A or B below:

    A. The modified Hestia criteria:

    • Systolic blood pressure > 100 mm Hg
    • No thrombolysis needed
    • No active bleeding
    • SaO2 >94% while breathing room air
    • Not already anticoagulated
    • No more than two doses of IV narcotics in the emergency department
    • Other medical or social reasons to admit
    • Creatinine clearance >30mL/min
    • Not pregnant, severe liver disease or heparin induced thrombocytopenia OR

    B. The physician opinion that a patients' overall social and medical situation is favorable for home treatment and the patient has a zero score on the simplified pulmonary embolism severity index (sPESI).

    All of the following must true:

    • Age < 81 years
    • No history of cancer
    • No history of heart failure or chronic lung disease
    • Pulse < 110 beats/min
    • SBP > 99 mm Hg
    • O2 sat >89%%

    We have chosen either criteria because both have been found equal in terms of safety for outpatient treatment of PE.6,22 Hestia includes implicit questions that most emergency physicians would use as criteria for discharge (e.g., overall medical status and social situation), whereas sPESI does not. For that reason, we have added the additional gestalt assessment question about physician discretion.

  2. Patients must be discharged in <24 hours after triage in an ED visit with diagnosis of VTE using objective criteria in the emergency department.

Exclusion Criteria:

  • VTE diagnosis while taking anticoagulants with evidence of compliance (e.g., physician opinion that patient is taking a Eliquis®, Xarelto® or Pradaxa®, low molecular weight heparin injections or warfarin as prescribed for any condition)
  • Sensitivity or contraindication to use of apixaban
  • Troponin assay value, drawn as part of usual care and found to be positive, using local standards
  • High risk for hemorrhage defined by a score>1.5 using the method of Ruiz Gimenez.3 (Note that several criteria are already excluded by Hestia):

Recent major bleeding, 2 points Creatinine levels >1.2 mg/dl, 1.5 points Anemia, 1.5 points Cancer, 1 point Clinically overt PE, 1 point Age >75 years, 1 point

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404635

Contact: Jeffrey A Kline, MD 317-880-3900 jefkline@iu.edu
Contact: Kate Pettit, MS 317-962-1190 klpettit@iu.edu

United States, Indiana
Eskenazi Health System Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jeff A Kline, MD    317-880-3900    jefkline@iu.edu   
Contact: Kate L Pettit, MS    317-962-1190    klpettit@iu.edu   
Indiana University Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jeffrey A Kline, MD    317-880-3900    jefkline@iu.edu   
Contact: Kate L Pettit, MS    317-962-1190    klpettit@iu.edu   
Sponsors and Collaborators
Indiana University
Bristol-Myers Squibb

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT03404635     History of Changes
Other Study ID Numbers: CV185-562
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Embolism and Thrombosis
Venous Thromboembolism
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action