Venous ThromboembolismMATHVTENCT03404635
Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism
An observational study of Venous Thromboembolism, run by Indiana University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Apixaban and Rivaroxaban
- How many people
- 1,300 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Aug 2017to 8 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency department patients with new or recurrent VTE deemed low-risk by modified Hestia or clinician discretion and sPESI (-).
Who may be able to join
- Patients must be low risk, as defined by either A or B below:
- The modified Hestia criteria:
- Systolic blood pressure > 100 mm Hg
- No thrombolysis needed
- No active bleeding
- SaO2 >94% while breathing room air
Show all 21Show fewer
- 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
- 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.
- Patients must be discharged in <24 hours after triage in an ED visit with diagnosis of VTE using objective criteria in the emergency department.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eskenazi Health System
Indianapolis, Indiana, 46202
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Monotherapy Anticoagulation To Expedite Home Treatment of Venous
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
- Being tested
- Apixaban, Rivaroxaban
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Apixaban as standard of care for VTE
RivaroxabanDrug
Rivaroxaban as standard of care for VTE
| Study group | Role | What they receive |
|---|---|---|
| Apixaban for VTE | Not described Receives: Drug: Apixaban | |
| Rivaroxaban for VTE | Not described Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of re-hospitalization visits for VTE recurrence or bleeding
Re-hospitalization for > 24 hours due to VTE recurrence or bleeding
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start4 Aug 2017
- Primary completion8 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pfizer, Janssen Pharmaceuticals
- Responsible party
- Principal investigator, Jeffrey Kline, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404635
- Sponsor's protocol ID
- CV185-562
- Acronym
- MATHVTE
- Status last verified
- Aug 2020
- First submitted
- 19 Dec 2017
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kline JA, Adler DH, Alanis N, Bledsoe JR, Courtney DM, d'Etienne JP, Diercks DB, Garrett JS, Jones AE, Mackenzie DC, Madsen T, Matuskowitz AJ, Mumma BE, Nordenholz KE, Pagenhardt J, Runyon MS, Stubblefield WB, Willoughby CB. Monotherapy Anticoagulation to Expedite Home Treatment of Patients Diagnosed With Venous Thromboembolism in the Emergency Department: A Pragmatic Effectiveness Trial. Circ Cardiovasc Qual Outcomes. 2021 Jul;14(7):e007600. doi: 10.1161/CIRCOUTCOMES.120.007600. Epub 2021 Jun 21.
PubMed 34148351
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monotherapy Anticoagulation To Expedite Home Treatment of Venous
- ClinicalTrials.gov ID
- NCT03404635
- Acronym / sponsor ID
- MATHVTE / CV185-562
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pfizer, Janssen Pharmaceuticals
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban for VTE | – | Drug: Apixaban |
| Rivaroxaban for VTE | – | Drug: Rivaroxaban |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department patients with new or recurrent VTE deemed low-risk by modified Hestia or clinician discretion and sPESI (-).
Key inclusion criteria (21 listed)
- Patients must be low risk, as defined by either A or B below:
- 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.
- Patients must be discharged in <24 hours after triage in an ED visit with diagnosis of VTE using objective criteria in the emergency department.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanApixaban as standard of care for VTE | Drug | Apixaban for VTE |
| RivaroxabanRivaroxaban as standard of care for VTE | Drug | Rivaroxaban for VTE |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Derived from this study: PubMed 34148351Kline JA, Adler DH, Alanis N, Bledsoe JR, Courtney DM, d'Etienne JP, Diercks DB, Garrett JS, Jones AE, Mackenzie DC, Madsen T, Matuskowitz AJ, Mumma BE, Nordenholz KE, Pagenhardt J, Runyon MS, Stubblefield WB, Willoughby CB. Monotherapy Anticoagulation to Expedite Home Treatment of Patients Diagnosed With Venous Thromboembolism in the Emergency Department: A Pragmatic Effectiveness Trial. Circ Cardiovasc Qual Outcomes. 2021 Jul;14(7):e007600. doi: 10.1161/CIRCOUTCOMES.120.007600. Epub 2021 Jun 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of re-hospitalization visits for VTE recurrence or bleeding (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.