A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery
Completed · Phase 2 · Has a placebo group
Conditions studied: Arthroplasty, Replacement, Knee
In brief
The purpose of this study is to determine the efficacy of JNJ-70033093 in preventing total venous thromboembolism (VTE) events (proximal and/or distal deep vein thrombosis \[DVT\] \[asymptomatic confirmed by venography assessment or objectively confirmed symptomatic\], nonfatal pulmonary embolism \[PE\], or any death) during the treatment period.
Key facts
- Study ID
- NCT03891524
- Run by
- Janssen Research & Development, LLC
- People needed
- 1242
- Starts
- 2019-06-17
- Expected to finish
- 2021-04-06
- Last updated by the study team
- 2025-03-30
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Medically stable and appropriate for anticoagulant prophylaxis as determined by the investigator on the basis of physical examination, medical history, and vital signs performed as part of screening for elective total knee replacement (TKR) surgery
- Medically stable and appropriate for anticoagulant prophylaxis on the basis of clinical laboratory tests performed as part of local standard-of-care as part of screening for elective TKR surgery
- Has plans to undergo an elective primary unilateral TKR surgery
- A woman must be- a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of less than [<]1 percent [%] per year when used consistently and correctly) and agrees to remain on a highly effective method for the duration of study drug with JNJ-70033093 plus 5 half-lives of study drug plus 30 days (duration of ovulatory cycle) for a total of 34 days after the completion of treatment, pregnancy testing (serum or urine) prior to the first dose of study drug
- Willing and able to adhere to the lifestyle restrictions specified in this protocol
You may not qualify if…
- History of any condition for which the use of low molecular-weight heparin (LMWH) is not recommended in the opinion of the investigator (for example, previous allergic reaction, creatinine clearance <30 milliliter per minute [mL/minute])
- History of severe hepatic impairment
- Planned bilateral revision or unicompartmental procedure
- Unable to undergo venography (for example, due to contrast agent allergy, poor venous access, or impaired renal function that would increase the risk of contrast-induced nephropathy
- Known previous pulmonary embolism (PE) or deep vein thrombosis (DVT) in either lower extremity
Where it is running
- Arizona Research Center — Phoenix, Arizona, United States
- Bowen Hefley Orthopedics — Little Rock, Arkansas, United States
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
- Denver Metro Orthopedics, PC — Englewood, Colorado, United States
- DMI Research — Pinellas Park, Florida, United States
- Gulfcoast Research Institute — Sarasota, Florida, United States
- University Orthopedic and Joint Replacement Center — Tamarac, Florida, United States
- Memorial Hermann Memorial City Medical Center — Houston, Texas, United States
- Hospital Britanico de Buenos Aires — Buenos Aires, Argentina
- Clinica Adventista Belgrano — CABA, Argentina
- Hospital San Roque — Córdoba, Argentina
- Clínica Chutro — Córdoba, Argentina
- Hospital Italiano La Plata — La Plata, Argentina
- Instituto de Investigaciones Clinicas Rosario — Rosario, Argentina
- Sanatorio Corporación Médica de General San Martín — San Martin, Argentina
- ZNA Middelheim — Antwerp, Belgium
- Ziekenhuis Oost-Limburg — Genk, Belgium
- Jessa Ziekenhuis — Hasselt, Belgium
- ZNA Jan Palfijn — Merksem, Belgium
- Hospital Sao Francisco de Assis — Belo Horizonte, Brazil
- Hospital e Maternidade Dr Christovao da Gama S.A — Santo André, Brazil
- Hospital Estadual Mario covas — Santo André, Brazil
- University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski — Pleven, Bulgaria
- Acibadem City Clinic Tokuda Hospital — Sofa, Bulgaria
- Central Research Associates, Inc. — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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