A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery (AXIOMATIC-TKR)

March 28, 2025 updated by: Janssen Research & Development, LLC

A Randomized, Open-Label, Study Drug-Dose Blind, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-70033093 (BMS-986177), an Oral Factor XIa Inhibitor, Versus Subcutaneous Enoxaparin in Subjects Undergoing Elective Total Knee Replacement Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

JNJ-70033093 is an oral anticoagulant for prevention and treatment of thromboembolic events (for example, VTE) that binds and inhibits activated form of human coagulation Factor XI (FXIa) with high affinity and selectivity. The study will consist of 3 phases: up to 30-day screening phase before total knee replacement (TKR) surgery, 10 to14 day postoperative dosing phase, and 4-week follow-up phase. The hypothesis of this study is JNJ-70033093 reduces risk of total VTE during treatment period. The total duration of participation following randomization will be approximately 6 weeks. Efficacy evaluations include unilateral venography assessment of operated leg and assessments of symptomatic DVT, PE, or death. Safety evaluation includes adverse events, clinical laboratory tests, and physical examinations. The safety and efficacy will be monitored throughout the study.

Study Type

Interventional

Enrollment (Actual)

1242

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, C1430EGF
        • Clinica Adventista Belgrano
      • Ciudad Autonoma de Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Córdoba, Argentina, 5000
        • Hospital San Roque
      • Córdoba, Argentina, X5000EPU
        • Clínica Chutro
      • La Plata, Argentina, B1900AXI
        • Hospital Italiano La Plata
      • Rosario, Argentina, S2000BIF
        • Instituto de Investigaciones Clinicas Rosario
      • San Martín, Argentina, B1650BNB
        • Sanatorio Corporación Médica de General San Martín
  • Belgium
      • Antwerpen, Belgium, 2020
        • Zna Middelheim
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis
      • Merksem, Belgium, 2170
        • ZNA Jan Palfijn
  • Brazil
      • Belo Horizonte, Brazil, 30360-290
        • Hospital Sao Francisco de Assis
      • Santo Andre, Brazil, 09030-010
        • Hospital e Maternidade Dr Christovao da Gama S.A
      • Santo André, Brazil, 09190-615
        • Hospital Estadual Mario Covas
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
      • Sofa, Bulgaria, 1407
        • Acibadem City Clinic Tokuda Hospital
      • Sofia, Bulgaria, 1330
        • University Multiprofile Hospital Sofiamed Sofia
      • Sofia, Bulgaria, 1527
        • MHAT Tzaritza Joanna
      • Stara Zagora, Bulgaria, 6000
        • Medical Center - Medical Complex BEROE EOOD
  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J4
        • Lakeridge Health
      • Hamilton, Ontario, Canada, L8V1C3
        • Hamilton Health Sciences Corporation
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Research Institute
      • Windsor, Ontario, Canada, N8W 1E6
        • Medical Investigative and Clinical Evaluation Inc
  • Greece
      • Kifisia, Greece, 14561
        • General Hospital of Attiki 'KAT'
      • Nea Ionia, Greece, 14233
        • General Hospital of Nea Ionia 'Konstantopoulio'
      • Patras, Greece, 26504
        • University General Hospital of Rio Patras
      • Thessaloniki, Greece, 56403
        • Papageorgiou General Hospital
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem
      • Gyõr, Hungary, 9023
        • Petz Aladar Megyei Oktato Korhaz
      • Kaposvar, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz
      • Kecskemét, Hungary, 6000
        • Bacs-kiskun Megyei Korhaz
      • Szeged, Hungary, 6725
        • Szegedi Tudomanyegyetem
      • Szekesfehervar, Hungary, 8000
        • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
      • Szolnok, Hungary, 5000
        • MAV Korhaz es Rendelointezet
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Kfar Saba, Israel, 44281
        • Meir Medical Center
      • Rehovot, Israel, 7610001
        • Kaplan Medical Center
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Bergamo, Italy, 24125
        • Cliniche Humanitas Gavazzeni
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli
      • Pavia, Italy, 27100
        • Policlinico S. Matteo
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
      • Torino, Italy, 10126
        • A.O.U. Città della Salute e della Scienza
  • Japan
      • Chiba, Japan, 270-2296
        • Matsudo City General Hospital
      • Hakodate, Japan, 040 8611
        • Hakodate Goryoukaku Hospital
      • Hamamatsu, Japan, 434-8533
        • Japanese Red Cross Hamamatsu Hospital
      • Itami-shi, Japan, 664-8540
        • Itami City Hospital
      • Kagoshima-shi, Japan, 890-0062
        • Yonemori Hospital
      • Kitakyushu-shi, Japan, 806-8501
        • Japan Community Health care Organization Kyushu Hospital
      • Matsumoto, Japan, 390-8601
        • Marunouchi Hospital
      • Nagoya, Japan, 455-8530
        • Chubu Rosai Hospital
      • Nerima-Ku, Japan, 177-8521
        • Juntendo University Nerima Hospital
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
      • Okinawa, Japan, 901-0224
        • Yuuai Medical Center
      • Saitama, Japan, 350-8550
        • Japan Community Health Care Organization Saitama Medical Center
      • Saitama-shi, Japan, 336-8522
        • Saitama City Hospital
      • Suzaka, Japan, 386-8610
        • Nagano Prefectural Shinshu Medical Center
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital
  • Poland
      • Bielsk Podlaski, Poland, 17 100
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bielsku Podlaskim Oddzial Urazowo Ortopedyczny
      • Grajewo, Poland, 19-200
        • Szpital Ogolny im. W. Ginela, Oddzial Urazowo-Ortopedyczny
      • Kielce, Poland, 25-001
        • Wojewodzki Szpital Zespolony w Kielcach, Klinika Chirurgii Ortopedyczno-Urazowej
      • Krakow, Poland, 31 826
        • Oddzial Ortopedii i Traumatologii Narzadu Ruchu Szpital Specjalistyczny im Ludwika Rydygiera
      • Lodz, Poland, 92-213
        • CSK UM Klinika Ortopedii
      • Lublin, Poland, 20-718
        • Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny
      • Tarnow, Poland, 33-100
        • Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika
      • Warszawa, Poland, 03 242
        • Oddzial Chirurgii Urazowej iOrtopedycznej Wojewodzki Szpital Brodnowski SPZOZ
      • Wroclaw, Poland, 50 556
        • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
  • Portugal
      • Aveiro, Portugal, 3810-501
        • Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro
      • Cascais, Portugal, 2755-009
        • Hosp de Cascais
      • Porto, Portugal, 4099-001
        • H. Santo António - Centro Hospitalar do Porto
      • Setubal, Portugal, 2900-180
        • CHS - Hosp. Orto. Sant'Iago do Outao
      • Viana do Castelo, Portugal, 4904-858
        • ULSAM, EPE - Hospital de Santa Luzia
  • Russian Federation
      • Kurgan, Russian Federation, 640014
        • National Medical Research Center of Traumatology and Orthopaedics n.a. G.A. Ilizarov
      • Moscow, Russian Federation, 109386
        • Private Healthcare Institution 'Clinical Hospital 'RZD-Medcine' n.a. N.A.Semashko'
      • Nizhniy Novgorod, Russian Federation, 603137
        • Privolzhsky Regional Medical Center of Federal Medical and Biological Agency
      • Saint-Petersburg, Russian Federation, 195427
        • National medical research center of Traumatology and Orthopaedics n.a. R.R.Vreden
      • Samara, Russian Federation, 443095
        • State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin
      • Smolensk, Russian Federation, 214031
        • Smolensk Federal Center of Traumatology, Orthopedics and Endoprothesis Replacement
      • Sochi, Russian Federation, 354057
        • Sochi City Hospital #4
  • South Africa
      • Pretoria, South Africa, 0001
        • Steve Biko Academic Hospital
      • Worcester, South Africa, 6850
        • Clinical Project Research SA
  • Spain
      • Alcorcón, Spain, 28922
        • Hosp. Univ. Fundacion Alcorcon
      • Badalona, Spain, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spain, 08907
        • Hosp. Univ. de Bellvitge
      • Barcelona, Spain, 08036
        • Hosp Clinic de Barcelona
      • Barcelona, Spain, 8035
        • Hosp Univ Vall D Hebron
      • Jaen, Spain, 23007
        • Complejo Hospitalario de Jaen
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28046
        • Hosp. Univ. La Paz
      • Sabadell, Spain, 08208
        • Corporacio Sanitari Parc Tauli
      • Valencia, Spain, 46010
        • Hosp. Clinico Univ. de Valencia
      • Valencia, Spain, 46026
        • Hosp. Univ. I Politecni La Fe
  • Turkey
      • Adana, Turkey, 01060
        • Adana City Hospital
      • Ankara, Turkey, 06370
        • Yıldırım Beyazıt University Yenimahalle Training and Research Hospital
      • Ankara, Turkey, 06110
        • Diskapi Yildırim Beyazid Training and Research Hospital
      • Antalya, Turkey, 07100
        • Antalya Training and Research Hospital
      • Istanbul, Turkey, 34147
        • Bakirkoy Training and Research Hospital
      • Istanbul, Turkey, 34371
        • Sisli Etfal Research Training Hospital
      • Izmir, Turkey, 35180
        • Izmir Tepecik Training and Research Hospital
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76008
        • Ivano-Frankivsk Regional Clinical Hospital
      • Kharkiv, Ukraine, 61024
        • Institute of Spine and JointPathology named after Prof.Sytenko of NationalAcademy of MedicalSciences
      • Kharkiv, Ukraine, 61176
        • Municipal Institution of Health Care 'Kharkiv Regional Clinical Traumatology Hospital'
      • Kyiv, Ukraine, 04107
        • Kyiv Regional Clinical Hospital
      • Lviv-Vynnyky, Ukraine, 79495
        • Communal Institution of Lviv Regional Council 'Lypa Lviv Regional Hospital'
      • Odesa, Ukraine, 65025
        • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
      • Vinnytsia, Ukraine, 21018
        • Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates, Inc.
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Bowen Hefley Orthopedics
    • California
      • Torrance, California, United States, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Denver Metro Orthopedics, PC
    • Florida
      • Pinellas Park, Florida, United States, 33782
        • DMI Research
      • Sarasota, Florida, United States, 34232
        • Gulfcoast Research Institute
      • Tamarac, Florida, United States, 33321
        • University Orthopedic and Joint Replacement Center
    • Texas
      • Houston, Texas, United States, 77024
        • Memorial Hermann Memorial City Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: JNJ-70033093 25 mg + Placebo BID
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.
Drug: JNJ-70033093 25 mg
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.
Other Names:
  • BMS-986177
Drug: Placebo
Participants will receive placebo matching to JNJ-70033093, orally.
Experimental: Group B: JNJ-70033093 50 mg BID
Participants will receive JNJ-70033093 50 mg (2*25 mg capsules) BID orally for 10 to 14 postoperative days.
Drug: JNJ-70033093 50 mg
Participants will receive JNJ-70033093 50 mg (2*25 mg capsules) BID orally for 10 to 14 postoperative days.
Other Names:
  • BMS-986177
Experimental: Group C: JNJ-70033093 100 mg + Placebo BID
Participants will receive JNJ-70033093 100 mg (1*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
Drug: Placebo
Participants will receive placebo matching to JNJ-70033093, orally.
Drug: JNJ-70033093 100 mg
Participants will receive JNJ-70033093 100 mg (1*100 mg capsule) BID, orally for 10 to 14 postoperative days.
Other Names:
  • BMS-986177
Experimental: Group D: JNJ-70033093 200 mg BID
Participants will receive JNJ-70033093 200 mg (2*100 mg capsules) BID orally for 10 to 14 postoperative days.
Drug: JNJ-70033093 200 mg
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.
Other Names:
  • BMS-986177
Experimental: Group E: JNJ-70033093 25 mg Once Daily + Placebo
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.
Drug: JNJ-70033093 25 mg
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.
Other Names:
  • BMS-986177
Drug: Placebo
Participants will receive placebo matching to JNJ-70033093, orally.
Experimental: Group F: JNJ-70033093 200 mg Once Daily + Placebo
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.
Drug: Placebo
Participants will receive placebo matching to JNJ-70033093, orally.
Drug: JNJ-70033093 200 mg
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.
Other Names:
  • BMS-986177
Experimental: Group G: JNJ-70033093 50 mg once daily + Placebo
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.
Drug: Placebo
Participants will receive placebo matching to JNJ-70033093, orally.
Drug: JNJ-70033093 50 mg
Participants will receive JNJ-70033093 50 mg (2*25 mg capsules) BID orally for 10 to 14 postoperative days.
Other Names:
  • BMS-986177
Active Comparator: Group I: Enoxaparin 40 mg Once Daily
Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
Drug: Enoxaparin 40 mg
Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)
Time Frame: Up to Day 14
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.
Up to Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Any Bleeding Event (CEC-adjudicated)
Time Frame: Up to Day 14; Up to Day 52
Any bleeding was defined as the composite of major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria modified for the surgical setting, clinically relevant nonmajor bleeding events, or minimal bleeding events as assessed by the CEC.
Up to Day 14; Up to Day 52
Number of Participants With Total VTE (CEC-adjudicated)
Time Frame: Up to Day 52
Total VTE was defined as the composite of (CEC-adjudicated) proximal and/or DVT (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal PE, or any death.
Up to Day 52
Number of Participants With Composite of Major and Clinically Relevant Nonmajor Bleeding (CRNM) Events (CEC-adjudicated)
Time Frame: Up to Day 14, Up to Day 52
Composite of Major bleeding event (BE): Fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; surgical site bleeding that requires second intervention open, arthroscopic, endovascular,or hemarthrosis resulting in prolonged hospitalization, deep wound infection and/or either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: Epistaxis, Gastrointestinal bleed,Hematuria,Bruising/ecchymosis,Hemoptysis,Hematoma.
Up to Day 14, Up to Day 52
Number of Participants With Major Bleeding Events (CEC-adjudicated)
Time Frame: Up to Day 14; Up to Day 52
Number of participants with major BE (adjudicated by CEC) were reported. Major Bleeding events were defined as: fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.
Up to Day 14; Up to Day 52
Number of Participants With CRNM Bleeding Events (CEC-adjudicated)
Time Frame: Up to Day 14; Up to Day 52
Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.
Up to Day 14; Up to Day 52
Number of Participants With Minimal Bleeding Events (CEC-adjudicated)
Time Frame: Up to Day 14; Up to Day 52
Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.
Up to Day 14; Up to Day 52
Number of Participants With Major or CRNM Bleeding Events (CEC-adjudicated)
Time Frame: Up to Day 14; Up to Day 52
Major Bleeding events were defined as: fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.
Up to Day 14; Up to Day 52
Number of Participants With Major VTE (CEC-adjudicated)
Time Frame: Up to Day 52
Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death.
Up to Day 52
Number of Participants With Major VTE (CEC-adjudicated)
Time Frame: Up to Day 14
Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death.
Up to Day 14
Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)
Time Frame: Up to Day 14
Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Up to Day 14
Number of Participants With Proximal DVT (CEC-adjudicated)
Time Frame: Up to Day 52
Number of participants with proximal DVT (CEC-adjudicated) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Up to Day 52
Number of Participants With Distal DVT (CEC-adjudicated)
Time Frame: Up to Day 14
Number of participants with distal DVT (CEC-adjudicated) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Up to Day 14
Number of Participants With Distal DVT (CEC-adjudicated)
Time Frame: Up to Day 52
Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Up to Day 52
Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)
Time Frame: Up to Day 14
Number of participants with nonfatal PE (adjudicated by CEC) were reported.
Up to Day 14
Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)
Time Frame: Up to Day 52
Number of participants with nonfatal PE (adjudicated by CEC) were reported.
Up to Day 52
Number of Participants With Deaths (CEC-adjudicated)
Time Frame: Up to Day 14
Number of participants with deaths (CEC-adjudicated) were reported.
Up to Day 14
Number of Participants With Deaths (CEC-adjudicated)
Time Frame: Up to Day 52
Number of participants with deaths (CEC-adjudicated) were reported.
Up to Day 52
Apparent Clearance (CL/F) of JNJ-70033093
Time Frame: Up to Day 14
Apparent clearance of a drug was defined as a measure of the rate at which a drug got metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Up to Day 14
Apparent Volume of Distribution (V/F) of JNJ-70033093
Time Frame: Up to Day 14
V/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
Up to Day 14
Impact of Selected Demographics: Apparent Clearance (CL/F) Based on Sex
Time Frame: Up to Day 14
Impact of demographic character (sex) on CL/F was assessed.
Up to Day 14
Impact of Selected Demographic: Age on CL/F
Time Frame: Up to Day 14
Impact of age on CL/F was assessed.
Up to Day 14
Impact of Selected Demographic: Weight on CL/F
Time Frame: Up to Day 14
Impact of weight on CL/F was assessed.
Up to Day 14
Impact of Selected Laboratory Values: Renal Function on CL/F
Time Frame: Up to Day 14
Impact of renal function on CL/F was assessed. The outcome measure was reported based on CRCL.
Up to Day 14
Impact of Selected Demographics: Sex on Apparent Volume of Distribution (V/F)
Time Frame: Up to Day 14
Impact of sex on V/F was assessed.
Up to Day 14
Impact of Selected Demographics : Age on V/F
Time Frame: Up to Day 14
Impact of age on V/F was assessed.
Up to Day 14
Impact of Selected Demographics : Weight on V/F
Time Frame: Up to Day 14
Impact of weight on V/F was assessed.
Up to Day 14
Impact of Selected Laboratory Values: Renal Function on V/F
Time Frame: Up to Day 14
Impact of renal function on V/F was assessed. The outcome measure is reported based on CRCL.
Up to Day 14
Trend Test for Primary Efficacy Event Rate (CEC Adjudicated) by Multiple Comparison Procedure - Modelling (MCP-Mod) Approach
Time Frame: Up to 14 days
The dose-response trend test based on the MCP-Mod framework consisted of contrast tests defined by prespecified candidate models (4 Emax dose-response models with varying degrees of ED50). Each model was evaluated for significance of trend, based on its optimal contrast, resulting in four t-test statistics, one for each candidate model. The t-test statistics were adjusted for the fact that 4 candidate models were included in the trend testing. The dose response of the drug was then established if the maximum of the t-test statistics exceeded the 95th percentile critical value. Here 'number' signifies the estimated response rate.
Up to 14 days
Trend Test for the Composite of On-Treatment Major and Clinically Relevant Nonmajor Bleeding (CEC Adjudicated) by MCP-Mod Approach
Time Frame: Up to 14 days
The dose-response trend test based on the MCP-Mod framework consisted of contrast tests defined by prespecified candidate models (4 Emax dose-response models with varying degrees of ED50). Each model was evaluated for significance of trend, based on its optimal contrast, resulting in four t-test statistics, one for each candidate model. The t-test statistics were adjusted for the fact that 4 candidate models were included in the trend testing. The dose response of the drug was then established if the maximum of the t-test statistics exceeded the 95th percentile critical value. Here 'number' signifies the estimated response rate.
Up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2019

Primary Completion (Actual)

April 6, 2021

Study Completion (Actual)

April 6, 2021

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108600
  • 70033093THR2001 (Other Identifier: Janssen Research & Development, LLC)
  • 2018-004237-32 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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