Deep Vein ThrombosisPhase 4NCT04169269
Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban
A Phase 4 study testing Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters and Rivaroxaban 10 milligram Oral Tablet in people with Deep Vein Thrombosis and Venous Thromboembolism, run by Florida Orthopaedic Institute at 1 site in United States.
Trial summary
The objective of this study is to compare oral rivaroxaban with injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Venous Thromboembolism
- What is being tested?
- Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters and Rivaroxaban 10 milligram Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to Dec 2021
- Phase
- Phase 4
- 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
Who may be able to join
- • Orthopaedic trauma patients deemed by the attending, treating surgeon to require an extended duration of venous thromboembolism chemoprophylaxis beyond that provided as an inpatient.
- Patients being discharged directly to home.
Who cannot join
- • Patients being discharged to a rehabilitation center or a skilled nursing facility.
- A contraindication to anticoagulation such as traumatic or other hemorrhage, as determined by the treating surgeon and/or consulting services.
- Ongoing venous thromboembolism treatment or extended prophylaxis (i.e. past history of multiple deep vein thrombosis/pulmonary embolism) for current or recent deep vein thrombosis, pulmonary embolism or other coagulopathic disorder
- Chronic anticoagulation for atrial fibrillation or other medical disorder requiring chronic anticoagulation therapy.
- Perceived low-risk patients requiring only aspirin or no pharmacological venous thromboembolism prophylaxis.
- Pregnant, prisoner, under 18 years old, or do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Florida Orthopaedic Institute
Tampa, Florida, 33606
Barbara Steverson, MHA, 813-253-2068, bsteverson@floridaortho.com
Randi Alexander, MPH, 8132532068, ralexander@floridaortho.com
About this study
Official title: Patient Adherence to Venous Thromboembolism Prophylaxis in Orthopaedic Trauma Patients: A Randomized, Controlled Trial Comparing Subcutaneous Enoxaparin & Oral Rivaroxaban
The objective of this study is to compare oral rivaroxaban with injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily.
Read the detailed description
This study is a randomized, controlled trial of orthopaedic trauma patients presenting to a single academic level one trauma center that require an extended course of venous thromboembolism event chemoprophylaxis. The goal is to compare oral rivaroxaban with our standard-of-care, injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily.
All patients included in the study would be treated with the standard enoxaparin 40 milligram injection while an inpatient. Upon hospital discharge, those requiring extended venous thromboembolism event chemoprophylaxis will be randomized to receive 20 days of either self-injected enoxaparin 40 milligrams or oral rivaroxaban,10 milligrams, a non-vitamin K oral anticoagulant. Both groups will then receive our current standard of care, aspirin 81 milligrams once daily for the remaining 3 weeks, for a total of 6 weeks of venous thromboembolism event chemoprophylaxis. Routine postoperative care will be provided by the treating surgeon.
- Conditions
- Deep Vein Thrombosis, Venous Thromboembolism
- Being tested
- Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters, Rivaroxaban 10 milligram Oral Tablet
- Medical subject headings
- Venous Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 millilitersDrug
Also called Lovenox
anticoagulant, subcutaneous injection
Rivaroxaban 10 milligram Oral TabletDrug
Also called Xarelto
anticoagulant, oral
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin | Active comparator | enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days Receives: Drug: Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters |
| Rivaroxaban | Active comparator | rivaroxaban oral 10 milligram tablet daily for 20 days Receives: Drug: Rivaroxaban 10 milligram Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to medication regimen
measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen
Measured: 2 weeks
adherence to medication regimen
measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen
Measured: 6 weeks
patient satisfaction with treatment regimen
measured with Treatment Satisfaction Questionnaire for Medication (TSQM-9) instrument. TSQM-9 scores have a range of 0 to 100, with higher scores indicating higher satisfaction.
Measured: 2 weeks
patient satisfaction with treatment regimen
measured with Treatment Satisfaction Questionnaire for Medication (TSQM-9) instrument. TSQM-9 scores have a range of 0 to 100, with higher scores indicating higher satisfaction.
Measured: 6 weeks
Secondary outcomes (7)
Number of participants with a bleeding event
measured through record review and participant reporting
Measured: 2 weeks
Number of participants with a bleeding event
measured through record review and participant reporting
Measured: 6 weeks
Number of participants with a bleeding event
measured through record review and participant reporting
Measured: 3 months
Number of participants with a clotting event
measured through record review and participant reporting
Measured: 2 weeks
Number of participants with a clotting event
measured through record review and participant reporting
Measured: 6 weeks
Number of participants with a clotting event
measured through record review and participant reporting
Measured: 3 months weeks
treatment cost
cost in U.S. dollars for 20 days of treatment drug
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start13 Jan 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
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 Deep Vein ThrombosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to one of two medications.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Orthopaedic Institute
- Sponsor type
- Research network
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Principal investigator, Barbara Steverson, Florida Orthopaedic Institute
- Investigators
- Hassan Mir, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169269
- Sponsor's protocol ID
- 20192684
- Status last verified
- Jan 2020
- First submitted
- 15 Nov 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
John MP 2nd, Streufert BD, Downes K, Chase CB, Mir HR. A Prospective Randomized Controlled Trial Comparing Enoxaparin & Rivaroxaban for Venous Thromboembolism Prophylaxis in Orthopaedic Trauma. J Orthop Trauma. 2022 Dec 1;36(12):615-622. doi: 10.1097/BOT.0000000000002454.
PubMed 36399673
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Adherence to Venous Thromboembolism Prophylaxis in Orthopaedic Trauma Patients: A Randomized, Controlled Trial Comparing Subcutaneous Enoxaparin & Oral Rivaroxaban
- ClinicalTrials.gov ID
- NCT04169269
- Acronym / sponsor ID
- 20192684
- Conditions
- Deep Vein Thrombosis, Venous Thromboembolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Florida Orthopaedic InstituteResearch network
- Collaborators
- Orthopaedic Trauma Association
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Nov 2019 (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.
The objective of this study is to compare oral rivaroxaban with injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily.
Detailed description
This study is a randomized, controlled trial of orthopaedic trauma patients presenting to a single academic level one trauma center that require an extended course of venous thromboembolism event chemoprophylaxis. The goal is to compare oral rivaroxaban with our standard-of-care, injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily.
All patients included in the study would be treated with the standard enoxaparin 40 milligram injection while an inpatient. Upon hospital discharge, those requiring extended venous thromboembolism event chemoprophylaxis will be randomized to receive 20 days of either self-injected enoxaparin 40 milligrams or oral rivaroxaban,10 milligrams, a non-vitamin K oral anticoagulant. Both groups will then receive our current standard of care, aspirin 81 milligrams once daily for the remaining 3 weeks, for a total of 6 weeks of venous thromboembolism event chemoprophylaxis. Routine postoperative care will be provided by the treating surgeon.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two medications.
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin | Active comparator | Drug: Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 millilitersenoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days |
| Rivaroxaban | Active comparator | Drug: Rivaroxaban 10 milligram Oral Tabletrivaroxaban oral 10 milligram tablet daily for 20 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Orthopaedic trauma patients deemed by the attending, treating surgeon to require an extended duration of venous thromboembolism chemoprophylaxis beyond that provided as an inpatient.
Key exclusion criteria (6 listed)
- • Patients being discharged to a rehabilitation center or a skilled nursing facility.
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 |
|---|---|---|
| Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 millilitersAlso: Lovenoxanticoagulant, subcutaneous injection | Drug | Enoxaparin |
| Rivaroxaban 10 milligram Oral TabletAlso: Xareltoanticoagulant, oral | Drug | Rivaroxaban |
Primary outcome
adherence to medication regimen
Time frame: 2 weeks
measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen
adherence to medication regimen
Time frame: 6 weeks
measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen
patient satisfaction with treatment regimen
Time frame: 2 weeks
measured with Treatment Satisfaction Questionnaire for Medication (TSQM-9) instrument. TSQM-9 scores have a range of 0 to 100, with higher scores indicating higher satisfaction.
patient satisfaction with treatment regimen
Time frame: 6 weeks
measured with Treatment Satisfaction Questionnaire for Medication (TSQM-9) instrument. TSQM-9 scores have a range of 0 to 100, with higher scores indicating higher satisfaction.
7 secondary outcomes
Number of participants with a bleeding event
Time frame: 2 weeks
Number of participants with a bleeding event
Time frame: 6 weeks
Number of participants with a bleeding event
Time frame: 3 months
Number of participants with a clotting event
Time frame: 2 weeks
Number of participants with a clotting event
Time frame: 6 weeks
Number of participants with a clotting event
Time frame: 3 months weeks
treatment cost
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 36399673John MP 2nd, Streufert BD, Downes K, Chase CB, Mir HR. A Prospective Randomized Controlled Trial Comparing Enoxaparin & Rivaroxaban for Venous Thromboembolism Prophylaxis in Orthopaedic Trauma. J Orthop Trauma. 2022 Dec 1;36(12):615-622. doi: 10.1097/BOT.0000000000002454.
- Individual participant dataSharing planned: No
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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.
Hassan Mir, MD principal investigator
Florida Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters and Rivaroxaban 10 milligram Oral Tablet in people with Deep Vein Thrombosis and Venous Thromboembolism, run by Florida Orthopaedic Institute at 1 site 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Steverson, MHA (8132532068, bsteverson@floridaortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to medication regimen (time frame: 2 weeks). The study lists 4 primary outcomes in all. 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 NCT04169269, 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 18 Jan 2020.