Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03891524 | A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery | PHASE2 | COMPLETED | 1,242 | — | — | Jun 17, 2019 | Apr 6, 2021 | Mar 30, 2025 | 117 | United States, Argentina +16 |
Total VTE was defined as the composite of clinical events committee (CEC)-adjudicated proximal and/or distal Deep Vein Thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death.
| Arm | Type | Description |
|---|---|---|
| Group A: JNJ-70033093 25 mg + Placebo BID | EXPERIMENTAL | Participants will receive JNJ-70033093 25 milligram (mg) (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days. |
| Group B: JNJ-70033093 50 mg BID | EXPERIMENTAL | Participants will receive JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days. |
| Group C: JNJ-70033093 100 mg + Placebo BID | EXPERIMENTAL | Participants will receive JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days. |
| Group D: JNJ-70033093 200 mg BID | EXPERIMENTAL | Participants will receive JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days. |
| Group E: JNJ-70033093 25 mg Once Daily + Placebo | EXPERIMENTAL | Participants will receive JNJ-70033093 25 mg (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days. |
| Group F: JNJ-70033093 200 mg Once Daily + Placebo | EXPERIMENTAL | Participants will receive JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days. |
| Group G: JNJ-70033093 50 mg once daily + Placebo | EXPERIMENTAL | Participants will receive JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days. |
| Group I: Enoxaparin 40 mg Once Daily | ACTIVE_COMPARATOR | Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days. |
| Name | Type | Description |
|---|---|---|
| JNJ-70033093 25 mg | DRUG | 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. |
| JNJ-70033093 50 mg | DRUG | Participants will receive JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days. |
| JNJ-70033093 100 mg | DRUG | Participants will receive JNJ-70033093 100 mg (1\*100 mg capsule) BID, orally for 10 to 14 postoperative days. |
| JNJ-70033093 200 mg | DRUG | 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. |
| Placebo | DRUG | Participants will receive placebo matching to JNJ-70033093, orally. |
| Enoxaparin 40 mg | DRUG | Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days. |
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 appro...