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Trial record 1 of 1 for:    NCT03404635
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Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism (MATHVTE)

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ClinicalTrials.gov Identifier: NCT03404635
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : August 7, 2020
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pfizer
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Jeffrey Kline, 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 Drug: Rivaroxaban

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Study Type : Observational
Actual Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monotherapy Anticoagulation To Expedite Home Treatment of Venous
Actual Study Start Date : August 4, 2017
Actual Primary Completion Date : May 8, 2020
Actual Study Completion Date : May 8, 2020

Resource links provided by the National Library of Medicine


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

Rivaroxaban for VTE Drug: Rivaroxaban
Rivaroxaban 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, Older Adult)
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 (-).
Criteria

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


Locations
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United States, Indiana
Eskenazi Health System
Indianapolis, Indiana, United States, 46202
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Bristol-Myers Squibb
Pfizer
Janssen Pharmaceuticals
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Responsible Party: Jeffrey Kline, Professor of Emergency Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03404635    
Other Study ID Numbers: CV185-562
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants