Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

NCT04169269 | Unknown Phase 4 FDA Drug

• 1 other identifier: 20192684
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deep Vein Thrombosis; Venous Thromboembolism

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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.

  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.

  6 weeks

Secondary Outcomes (7)

• Number of participants with a bleeding event

  2 weeks

• Number of participants with a bleeding event

  6 weeks

• Number of participants with a bleeding event

  3 months

• Number of participants with a clotting event

  2 weeks

• Number of participants with a clotting event

  6 weeks

Study Arms (2)

Enoxaparin

ACTIVE COMPARATOR

enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days

Drug: Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters

Rivaroxaban

ACTIVE COMPARATOR

rivaroxaban oral 10 milligram tablet daily for 20 days

Drug: Rivaroxaban 10 milligram Oral Tablet

Interventions

Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters DRUG

anticoagulant, subcutaneous injection

Also known as: Lovenox

Enoxaparin

Rivaroxaban 10 milligram Oral Tablet DRUG

anticoagulant, oral

Also known as: Xarelto

Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Orthopaedic Institute: lead
• Orthopaedic Trauma Association: collaborator

Study Sites (1)

Florida Orthopaedic Institute

Tampa, Florida, 33606, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36399673 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Venous Thromboembolism

Interventions

Enoxaparin; Rivaroxaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hassan Mir, MD

  Florida Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Steverson, MHA

CONTACT

8132532068; bsteverson@floridaortho.com

Randi Alexander, MPH

CONTACT

8132532068; bsteverson@floridaortho.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Orthopaedic Trauma Service

Model Details: Participants are randomized to one of two medications.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: January 13, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)