A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery
Condition: Arthroplasty, Replacement, Knee
Intervention: JNJ-70033093 25 mg; JNJ-70033093 50 mg; JNJ-70033093 100 mg; JNJ-70033093 200 mg; Placebo; Enoxaparin 40 mg
Intervention description: Participants will receive JNJ-70033093 25 mg (1*25 mg capsule) BID (in Group A) or once daily (in Group E), orally for 10 to 14 postoperative days.; Participants will receive JNJ-70033093 50 mg (2*25 mg capsules) BID orally for 10 to 14 postoperative days.; Participants will receive JNJ-70033093 100 mg (1*100 mg capsule) BID, orally for 10 to 14 postoperative days.; Participants will receive JNJ-70033093 200 mg (2*100 mg capsules) BID (in Group D) or once daily (in Group F), orally for 10 to 14 postoperative days.; Participants will receive placebo matching to JNJ-70033093, orally.; Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Treatment arms and study drug dose regimens will be blinded.
Enrollment: 1242.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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