Phase 2
Completed N=1,242
A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery
Arthroplasty, Replacement, Knee
Source: ClinicalTrials.gov NCT03891524 ↗
Enrolled (actual)
1,242
Serious AEs
2.7%
Results posted
Jul 2022
Primary outcomePrimary: Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated) — 7; 30; 27; 14 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated) |
7; 30; 27; 14; 8; 12 | — |
| SECONDARY Number of Participants With Any Bleeding Event (CEC-adjudicated) |
0; 8; 2; 7; 11; 7 | — |
| SECONDARY Number of Participants With Total VTE (CEC-adjudicated) |
7; 30; 27; 14; 8; 12 | — |
| SECONDARY Number of Participants With Composite of Major and Clinically Relevant Nonmajor Bleeding (CRNM) Events (CEC-adjudicated) |
0; 2; 0; 2; 1; 1 | — |
| SECONDARY Number of Participants With Major Bleeding Events (CEC-adjudicated) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With CRNM Bleeding Events (CEC-adjudicated) |
0; 2; 0; 2; 1; 1 | — |
| SECONDARY Number of Participants With Minimal Bleeding Events (CEC-adjudicated) |
0; 6; 2; 5; 8; 7 | — |
| SECONDARY Number of Participants With Major or CRNM Bleeding Events (CEC-adjudicated) |
0; 2; 0; 2; 1; 1 | — |
| SECONDARY Number of Participants With Major VTE (CEC-adjudicated) |
0; 2; 1; 1; 0; 2 | — |
| SECONDARY Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Proximal DVT (CEC-adjudicated) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Distal DVT (CEC-adjudicated) |
7; 27; 26; 13; 8; 10 | — |
| SECONDARY Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated) |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Deaths (CEC-adjudicated) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Apparent Clearance (CL/F) of JNJ-70033093 |
7.72 | — |
| SECONDARY Apparent Volume of Distribution (V/F) of JNJ-70033093 |
125 | — |
| SECONDARY Impact of Selected Demographics: Apparent Clearance (CL/F) Based on Sex |
7.14; 9.32 | — |
| SECONDARY Impact of Selected Demographic: Age on CL/F |
8.70; 6.83 | — |
| SECONDARY Impact of Selected Demographic: Weight on CL/F |
7.04; 8.54 | — |
| SECONDARY Impact of Selected Laboratory Values: Renal Function on CL/F |
6.71; 8.83 | — |
| SECONDARY Impact of Selected Demographics: Sex on Apparent Volume of Distribution (V/F) |
118; 143 | — |
| SECONDARY Impact of Selected Demographics : Age on V/F |
135; 116 | — |
| SECONDARY Impact of Selected Demographics : Weight on V/F |
109; 145 | — |
| SECONDARY Impact of Selected Laboratory Values: Renal Function on V/F |
116; 135 | — |
| SECONDARY Trend Test for Primary Efficacy Event Rate (CEC Adjudicated) by Multiple Comparison Procedure - Modelling (MCP-Mod) Approach |
0.35; 0.21; 0.20; 0.13; 0.09; 0.09 | 0.0004 sig |
| SECONDARY Trend Test for the Composite of On-Treatment Major and Clinically Relevant Nonmajor Bleeding (CEC Adjudicated) by MCP-Mod Approach |
0.02; 0.01; 0.01; 0.01; 0.01; 0.01 | 0.7188 |
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
Data sourced from ClinicalTrials.gov (NCT03891524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.