Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban After Orthopedic Surgery for Either Total Hip or Total Knee Replacement

NCT01094886 | Completed Phase 3 Results DMC

• 2 other identifiers: CR016531RIVAROXCPK3001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 5

Brief Summary

The study will describe the short-term effects the study drug, rivaroxaban, has on the body when a patient is switched from enoxaparin injection (by needle) to oral rivaroxaban (by mouth) for the prevention of blood clotting in the veins after elective total hip or total knee replacement surgery. After providing written informed consent, screening procedures will be completed to assess eligibility. After enrollment, all patients will be switched from enoxaparin to rivaroxaban. Blood samples for the short-term effects of rivaroxaban will be taken at various times while in the subacute unit. At the time of discharge, if the study doctor feels it is appropriate, an adequate supply of rivaroxaban will be provided to complete the full course of therapy. Upon completion of rivaroxaban therapy, all patients will be required to have final study procedures performed. Safety evaluations at the final visit will include clinical blood laboratory tests, a physical examination, urine pregnancy test (if applicable), recording of any adverse events including details regarding any bleeding episodes or blood clot events, and assessment of the surgical wound. All patients will return any unused study medication and study participation will be complete.

Conditions

Arthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Thromboembolism

Keywords

Total Hip Replacement; Total Knee Replacement; Hip Implant; Knee Implant; Joint Prosthesis; Orthopedic Surgery; Rivaroxaban; Xarelto; Blood Clot

Outcome Measures

Primary Outcomes (2)

• Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa)

  Descriptive statistics for per-patient maximum Anti-Factor Xa laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3

  Day 1, Day 3

• Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time

  Descriptive statistics for per-patient maximum prothrombin time laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3

  Day 1, Day 3

Secondary Outcomes (2)

• Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa

  Day 1, Day 3

• Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time

  Day 1, Day 3

Study Arms (1)

001

EXPERIMENTAL

Rivaroxaban 10mg tablet daily receiving the first dose within two days after admission to the subacute unit. The total duration of combined venous blood clot prevention therapy with enoxaparin and rivaroxaban may not exceed 35 days for patients with total hip replacement or 14 days with total knee replacement

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

10mg tablet daily, receiving the first dose within two days after admission to the subacute unit. The total duration of combined venous blood clot prevention therapy with enoxaparin and rivaroxaban may not exceed 35 days for patients with total hip replacement or 14 days with total knee replacement

001

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergone elective total hip or knee replacement surgery
• Received postoperative venous blood clot prevention therapy within 24 hours of the surgery
• Currently prescribed enoxaparin 30mg subcutaneous (SQ) twice a day or 40mg SQ daily for venous blood clotting prevention with an expected duration of continued prevention therapy of at least 3 days after admission to a subacute unit
• Discharged from the hospital to a subacute unit (including skilled nursing facilities and rehabilitation units) and committed to remaining in the unit for the duration of the Pharmacodynamic blood sampling period of the study

You may not qualify if:

• Platelet count \<90,000/µL based on screening laboratory assessments
• active internal bleeding or high risk of bleeding
• history of, or condition associated with, increased bleeding risk including
• planned invasive procedure with potential for uncontrolled bleeding, including major surgery
• sustained uncontrolled high blood pressure, defined as systolic blood pressure =180 mmHg or diastolic blood pressure =100 mmHg
• clinically significant kidney disease and/or impaired kidney function
• clinically significant liver disease
• anemia
• known allergies, hypersensitivity, or intolerance to rivaroxaban
• indication for anticoagulant (blood thinning) therapy for a condition other than blood clot prevention
• anticipated need for treatment with a prescription or nonprescription non-steroidal anti-inflammatory drugs (NSAIDs)
• any patient who has taken more than one or two doses of aspirin (\>100 mg/dose) in the week prior to enrollment will not be allowed to participate
• Drug addiction or alcohol abuse within 3 years prior to screening

Sponsors & Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC: lead
• Bayer: collaborator

Study Sites (5)

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Hollywood, Florida, United States

Location

Unknown Facility

Tamarac, Florida, United States

Location

Unknown Facility

Vero Beach, Florida, United States

Location

Unknown Facility

Glen Cove, New York, United States

Location

MeSH Terms

Conditions

Arthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Thromboembolism; Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Osteoarthritis; Rheumatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

There were 56 subjects enrolled in the study, but only 53 of them were treated with study medication.

Results Point of Contact

• Title: VP Medical Affairs, Internal Medicine
• Organization: Janssen Scientific Affairs, LLC

1 908 218-7250

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 29, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 17, 2017
• Results First Posted: February 27, 2012

Record last verified: 2017-02

Locations

US (5)