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A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome (LIBREXIA-ACS)

Primary Purpose

Acute Coronary Syndrome

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Milvexian
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization: a) clinical syndrome consistent with spontaneous cardiac ischemia, b) diagnosis of acute coronary syndrome (ACS) (that is, ST-elevation myocardial infarction [STEMI], non-STEMI, or unstable angina [UA]), c) cardiac biomarker elevation (example, troponin I, troponin T, creatine kinase-MB [CK-MB]) above the upper limit of normal as determined by the local laboratory Participants must have at least 2 of the following risk factors:a) age 65 or older, b) diabetes mellitus, c) history of a prior myocardial infarction (MI) (other than index ACS event), d) multivessel coronary artery disease (CAD), e) history of coronary artery bypass graft (CABG) surgery prior to index ACS event, f) history of peripheral artery disease (PAD) or cerebrovascular disease (example, carotid atherosclerosis, intracranial artery stenosis, g) conservative management (that is, no percutaneous intervention [PCI] or CABG after index ACS event), h) Any one or more of the following high-risk angiographic features i) total stent length of greater than (>) 30 millimeters (mm), ii) thrombotic target lesion, iii) bifurcation lesion treated with more than one stent, iv) calcified target lesion treated with atherectomy, v) treatment of obstructive left main or proximal left anterior descending artery for index ACS (or clinical diagnosis of an anterior STEMI) All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening A female participant must not be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half-lives) after the last dose of study intervention Exclusion Criteria: MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event Planned CABG or staged PCI after randomization Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera)

Sites / Locations

  • Advanced Cardiovascular, LLCRecruiting
  • Ascension St. Vincent's Health SystemRecruiting
  • Mobile Heart Specialists, PCRecruiting
  • Mercy Gilbert Medical CenterRecruiting
  • Valleywise Health Medical CenterRecruiting
  • Arkansas Heart HospitalRecruiting
  • Mission Cardiovascular Research InstituteRecruiting
  • Radin Cardiovascular Medical GroupRecruiting
  • Valley Clinical Trials, Inc.Recruiting
  • The Cardiovascular CenterRecruiting
  • Sharp HealthCareRecruiting
  • Ramin Manshadi, MDRecruiting
  • South Denver Cardiology Associates PCRecruiting
  • Nuvance Health Medical Practices Cardiology DanburyRecruiting
  • Integrative Research AssociatesRecruiting
  • Shands Jacksonville Medical Center, Inc.dba UF Health JacksonvilleRecruiting
  • Cardiology Partners Clinical Research InstituteRecruiting
  • Cardiovascular Center of SarasotaRecruiting
  • Grady Memorial HospitalRecruiting
  • Atlanta Clinical Research CenterRecruiting
  • Northeast Georgia Heart CenterRecruiting
  • Kootenai Medical CenterRecruiting
  • Methodist Medical Center of IllinoisRecruiting
  • Prairie Cardiovascular Consultants, Ltd.Recruiting
  • Midwest Cardiovascular Research FoundationRecruiting
  • Reid HealthRecruiting
  • Cambridge Medical TrialsRecruiting
  • Louisiana Heart CenterRecruiting
  • Eastern Maine Medical Center Northeast Cardiology AssociatesRecruiting
  • Tidal Health Peninsula Regional Inc.Recruiting
  • St. Luke's Speciality ClinicRecruiting
  • Spectrum Clinical ResearchRecruiting
  • Bryan LGH Heart InstituteRecruiting
  • Methodist Physicians Clinic Heart ConsultantsRecruiting
  • Atlanticare Regional Medical CenterRecruiting
  • Cardiac Care & Vascular Medicine, PLLCRecruiting
  • Hudson Valley Cardiovascular Practice, PCRecruiting
  • UNC School of MedicineRecruiting
  • Clinical Trials of America
  • Sanford CardiologyRecruiting
  • Summa Health SystemRecruiting
  • Kettering Medical CenterRecruiting
  • The Heart HouseRecruiting
  • Ascension Medical Group - St. John Clinic Infectious DiseaseRecruiting
  • South Oklahoma Heart ResearchRecruiting
  • St John Health System IncRecruiting
  • AnMed HealthRecruiting
  • St. Francis Physician Services, Inc, DBA Upstate Cardiology ResearchRecruiting
  • Carolina Cardiology AssociatesRecruiting
  • Monument Health Clinical ResearchRecruiting
  • Apex CardiologyRecruiting
  • Tennessee OncologyRecruiting
  • Amarillo Heart Clinical Research InstituteRecruiting
  • PharmaTex ResearchRecruiting
  • Med Research, Inc.Recruiting
  • Texas Tech University Health Sciences Center-El PasoRecruiting
  • East Texas Cardiology, PARecruiting
  • Texas Cardiology Research CenterRecruiting
  • Ascension Texas CardiovascularRecruiting
  • Virginia HeartRecruiting
  • Winchester Medical CenterRecruiting
  • MultiCare Health SystemRecruiting
  • Ballarat Base HospitalRecruiting
  • Cardresearch - Cardiologia AssistencialRecruiting
  • Sociedade Hospitalar Angelina CaronRecruiting
  • C.E.C.-Centro Especializado em Cardiologia Ltda.- Loema Medicina e Bem EstarRecruiting
  • Santa Casa de Misericórdia de PelotasRecruiting
  • Associacao Hospitalar Moinhos de VentoRecruiting
  • Fundacao Universitaria de CardiologiaRecruiting
  • Hospital Alemao Oswaldo CruzRecruiting
  • Instituto Dante Pazzanese de CardiologiaRecruiting
  • Dr. Saul Vizel Cardiac Research OfficeRecruiting
  • Kawartha Cardiology Clinical TrialsRecruiting
  • Office of Dr. Anthony GlanzRecruiting
  • Clinique de Cardiologie de LevisRecruiting
  • CardioVasc HRRecruiting
  • Kasugai Municipal HospitalRecruiting
  • Hyogo Prefectural Amagasaki General Medical CenterRecruiting
  • Funabashi Munitiple Medical CenterRecruiting
  • Fukui Prefectural HospitalRecruiting
  • Fukuoka Wajiro HospitalRecruiting
  • Gifu Prefectural General Medical CenterRecruiting
  • National Hospital Organization Takasaki General Medical CenterRecruiting
  • Public Central Hospital of Matto IshikawaRecruiting
  • Fukuoka Tokushukai HospitalRecruiting
  • Kimitsu Chuo HospitalRecruiting
  • Kokura Memorial HospitalRecruiting
  • Chikamori HospitalRecruiting
  • National Hospital Organization Kure Medical Center and Chugoku Cancer CenterRecruiting
  • Chiba-Nishi General HospitalRecruiting
  • Jisenkai Aizawa HospitalRecruiting
  • Tokyo Saiseikai Central HospitalRecruiting
  • Okayama Rosai HospitalRecruiting
  • National Hospital Organization Osaka National HospitalRecruiting
  • Osaka City General HospitalRecruiting
  • Kosekai Iwatsuki-minami HospitalRecruiting
  • Kagawa Prefectural Central HospitalRecruiting
  • Ome Municipal General HospitalRecruiting
  • Tsukuba Medical Center HospitalRecruiting
  • Tokyobay Urayasu Ichikawa Medical CenterRecruiting
  • Sarawak General HospitalRecruiting
  • Hospital MiriRecruiting
  • University of OtagoRecruiting
  • Hawkes Bay HospitalRecruiting
  • Panorama MediClinicRecruiting
  • Tread ResearchRecruiting
  • Garda, RARecruiting
  • Dr J.M. Engelbrecht Trial SiteRecruiting
  • Helderberg Research InstituteRecruiting
  • Clinical Projects Research SA (PTY) LTDRecruiting
  • Changhua Christian HospitalRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • E-DA HospitalRecruiting
  • Far Eastern Memorial HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Cheng Hsin General HospitalRecruiting
  • Tri-Service General HospitalRecruiting
  • Taipei Municipal Wanfang HospitalRecruiting
  • Maharaj Nakorn Chiang Mai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Milvexian

Placebo

Arm Description

Participants enrolled within 7 days of an acute coronary syndrome (ACS), who have undergone cardiac catheterization with percutaneous intervention (PCI) or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (single antiplatelet therapy [SAPT] or dual antiplatelet therapy [DAPT]) as determined by the investigator will receive milvexian orally.

Participants enrolled within 7 days of an ACS, who have undergone cardiac catheterization with PCI or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) as determined by the investigator will receive placebo orally.

Outcomes

Primary Outcome Measures

Time to First Occurrence of Major Adverse Cardiovascular Event (MACE)
Time to first occurrence of any component of MACE will be reported. MACE is a composite of cardiovascular (CV) death, myocardial infarction (MI), and ischemic stroke.

Secondary Outcome Measures

Time to the First Occurrence of Major Adverse Vascular Event (MAVE)
Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of CV death, MI, ischemic stroke, major adverse limb event (MALE), and symptomatic venous thromboembolism (VTE).
Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke
Time to the first occurrence of composite of ACM, MI and ischemic stroke will be reported.
Time to Cardiovascular (CV) Death
Time to CV death will be reported.
Time to All-cause Mortality (ACM)
Time to ACM will reported. ACM will be categorized into CV death, non-CV death, and death due to unknown cause.

Full Information

First Posted
February 23, 2023
Last Updated
October 9, 2023
Sponsor
Janssen Research & Development, LLC
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05754957
Brief Title
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
Acronym
LIBREXIA-ACS
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
September 7, 2026 (Anticipated)
Study Completion Date
October 19, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Milvexian
Arm Type
Experimental
Arm Description
Participants enrolled within 7 days of an acute coronary syndrome (ACS), who have undergone cardiac catheterization with percutaneous intervention (PCI) or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (single antiplatelet therapy [SAPT] or dual antiplatelet therapy [DAPT]) as determined by the investigator will receive milvexian orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants enrolled within 7 days of an ACS, who have undergone cardiac catheterization with PCI or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) as determined by the investigator will receive placebo orally.
Intervention Type
Drug
Intervention Name(s)
Milvexian
Other Intervention Name(s)
JNJ-70033093, BMS-986177
Intervention Description
Milvexian will be administered orally.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered orally.
Primary Outcome Measure Information:
Title
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE)
Description
Time to first occurrence of any component of MACE will be reported. MACE is a composite of cardiovascular (CV) death, myocardial infarction (MI), and ischemic stroke.
Time Frame
Up to 3 years 6 months
Secondary Outcome Measure Information:
Title
Time to the First Occurrence of Major Adverse Vascular Event (MAVE)
Description
Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of CV death, MI, ischemic stroke, major adverse limb event (MALE), and symptomatic venous thromboembolism (VTE).
Time Frame
Up to 3 years 6 months
Title
Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke
Description
Time to the first occurrence of composite of ACM, MI and ischemic stroke will be reported.
Time Frame
Up to 3 years 6 months
Title
Time to Cardiovascular (CV) Death
Description
Time to CV death will be reported.
Time Frame
Up to 3 years 6 months
Title
Time to All-cause Mortality (ACM)
Description
Time to ACM will reported. ACM will be categorized into CV death, non-CV death, and death due to unknown cause.
Time Frame
Up to 3 years 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization: a) clinical syndrome consistent with spontaneous cardiac ischemia, b) diagnosis of acute coronary syndrome (ACS) (that is, ST-elevation myocardial infarction [STEMI], non-STEMI, or unstable angina [UA]), c) cardiac biomarker elevation (example, troponin I, troponin T, creatine kinase-MB [CK-MB]) above the upper limit of normal as determined by the local laboratory Participants must have at least 2 of the following risk factors:a) age 65 or older, b) diabetes mellitus, c) history of a prior myocardial infarction (MI) (other than index ACS event), d) multivessel coronary artery disease (CAD), e) history of coronary artery bypass graft (CABG) surgery prior to index ACS event, f) history of peripheral artery disease (PAD) or cerebrovascular disease (example, carotid atherosclerosis, intracranial artery stenosis, g) conservative management (that is, no percutaneous intervention [PCI] or CABG after index ACS event), h) Any one or more of the following high-risk angiographic features i) total stent length of greater than (>) 30 millimeters (mm), ii) thrombotic target lesion, iii) bifurcation lesion treated with more than one stent, iv) calcified target lesion treated with atherectomy, v) treatment of obstructive left main or proximal left anterior descending artery for index ACS (or clinical diagnosis of an anterior STEMI) All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening A female participant must not be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half-lives) after the last dose of study intervention Exclusion Criteria: MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event Planned CABG or staged PCI after randomization Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Cardiovascular, LLC
City
Alexander City
State/Province
Alabama
ZIP/Postal Code
35010
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension St. Vincent's Health System
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
Mobile Heart Specialists, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Individual Site Status
Recruiting
Facility Name
Valleywise Health Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Individual Site Status
Recruiting
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Name
Mission Cardiovascular Research Institute
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Name
Radin Cardiovascular Medical Group
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Individual Site Status
Recruiting
Facility Name
The Cardiovascular Center
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Individual Site Status
Recruiting
Facility Name
Sharp HealthCare
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Ramin Manshadi, MD
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Individual Site Status
Recruiting
Facility Name
South Denver Cardiology Associates PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Name
Nuvance Health Medical Practices Cardiology Danbury
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Individual Site Status
Recruiting
Facility Name
Integrative Research Associates
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Individual Site Status
Recruiting
Facility Name
Shands Jacksonville Medical Center, Inc.dba UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiology Partners Clinical Research Institute
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiovascular Center of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239-3513
Country
United States
Individual Site Status
Recruiting
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Clinical Research Center
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30121
Country
United States
Individual Site Status
Recruiting
Facility Name
Northeast Georgia Heart Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Name
Kootenai Medical Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Individual Site Status
Recruiting
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Individual Site Status
Recruiting
Facility Name
Prairie Cardiovascular Consultants, Ltd.
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Cardiovascular Research Foundation
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514-2487
Country
United States
Individual Site Status
Recruiting
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Individual Site Status
Recruiting
Facility Name
Cambridge Medical Trials
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Individual Site Status
Recruiting
Facility Name
Louisiana Heart Center
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastern Maine Medical Center Northeast Cardiology Associates
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Individual Site Status
Recruiting
Facility Name
Tidal Health Peninsula Regional Inc.
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Luke's Speciality Clinic
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55802-2207
Country
United States
Individual Site Status
Recruiting
Facility Name
Spectrum Clinical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Individual Site Status
Recruiting
Facility Name
Bryan LGH Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Recruiting
Facility Name
Methodist Physicians Clinic Heart Consultants
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanticare Regional Medical Center
City
Pomona
State/Province
New Jersey
ZIP/Postal Code
08402
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiac Care & Vascular Medicine, PLLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10469
Country
United States
Individual Site Status
Recruiting
Facility Name
Hudson Valley Cardiovascular Practice, PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Individual Site Status
Recruiting
Facility Name
UNC School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-5021
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of America
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Individual Site Status
Terminated
Facility Name
Sanford Cardiology
City
Sanford
State/Province
North Carolina
ZIP/Postal Code
27330
Country
United States
Individual Site Status
Recruiting
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Individual Site Status
Recruiting
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Individual Site Status
Recruiting
Facility Name
The Heart House
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Medical Group - St. John Clinic Infectious Disease
City
Bartlesville
State/Province
Oklahoma
ZIP/Postal Code
74006
Country
United States
Individual Site Status
Recruiting
Facility Name
South Oklahoma Heart Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Individual Site Status
Recruiting
Facility Name
St John Health System Inc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Name
AnMed Health
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Francis Physician Services, Inc, DBA Upstate Cardiology Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Cardiology Associates
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Recruiting
Facility Name
Monument Health Clinical Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Name
Apex Cardiology
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Name
Amarillo Heart Clinical Research Institute
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Recruiting
Facility Name
PharmaTex Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
Individual Site Status
Recruiting
Facility Name
Med Research, Inc.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Tech University Health Sciences Center-El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Name
East Texas Cardiology, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Cardiology Research Center
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Texas Cardiovascular
City
Kyle
State/Province
Texas
ZIP/Postal Code
78640
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Heart
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Name
Winchester Medical Center
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Individual Site Status
Recruiting
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Ballarat Base Hospital
City
Ballarat
ZIP/Postal Code
3350
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cardresearch - Cardiologia Assistencial
City
Belo Horizonte
ZIP/Postal Code
30150-240
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sociedade Hospitalar Angelina Caron
City
Campina Grande Do Sul
ZIP/Postal Code
83430-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
C.E.C.-Centro Especializado em Cardiologia Ltda.- Loema Medicina e Bem Estar
City
Campinas
ZIP/Postal Code
13010-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Santa Casa de Misericórdia de Pelotas
City
Pelotas
ZIP/Postal Code
96015-290
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Associacao Hospitalar Moinhos de Vento
City
Porto Alegre
ZIP/Postal Code
90035-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Universitaria de Cardiologia
City
Porto Alegre
ZIP/Postal Code
90620-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Alemao Oswaldo Cruz
City
Sao Paulo
ZIP/Postal Code
01323-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Sao Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Dr. Saul Vizel Cardiac Research Office
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 7R1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Kawartha Cardiology Clinical Trials
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 0B2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Office of Dr. Anthony Glanz
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinique de Cardiologie de Levis
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 4Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
CardioVasc HR
City
St Jean sur Richelieu
State/Province
Quebec
ZIP/Postal Code
J3A1C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Kasugai Municipal Hospital
City
Aichi
ZIP/Postal Code
486-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Prefectural Amagasaki General Medical Center
City
Amagasaki-shi
ZIP/Postal Code
660-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Funabashi Munitiple Medical Center
City
Chiba
ZIP/Postal Code
273-8588
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukui Prefectural Hospital
City
Fukui-shi
ZIP/Postal Code
910-0846
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka Wajiro Hospital
City
Fukuoka-shi
ZIP/Postal Code
811-0213
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gifu Prefectural General Medical Center
City
Gifu
ZIP/Postal Code
500-8717
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Takasaki General Medical Center
City
Gunma
ZIP/Postal Code
370-0829
Country
Japan
Individual Site Status
Recruiting
Facility Name
Public Central Hospital of Matto Ishikawa
City
Ishikawa
ZIP/Postal Code
924-0865
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka Tokushukai Hospital
City
Kasuga-shi
ZIP/Postal Code
816-0864
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kimitsu Chuo Hospital
City
Kisarazu-shi
ZIP/Postal Code
292-8535
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kokura Memorial Hospital
City
Kitakyushu-shi
ZIP/Postal Code
802-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chikamori Hospital
City
Kochi
ZIP/Postal Code
780-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
City
Kure-shi
ZIP/Postal Code
736-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba-Nishi General Hospital
City
Matsudo-shi
ZIP/Postal Code
270-2251
Country
Japan
Individual Site Status
Recruiting
Facility Name
Jisenkai Aizawa Hospital
City
Matsumoto-shi
ZIP/Postal Code
390-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Saiseikai Central Hospital
City
Minato-ku
ZIP/Postal Code
108-0073
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama Rosai Hospital
City
Okayama-shi
ZIP/Postal Code
702-8055
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka-shi
ZIP/Postal Code
540-0006
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kosekai Iwatsuki-minami Hospital
City
Saitama-shi
ZIP/Postal Code
339-0033
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu
ZIP/Postal Code
760-8557
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ome Municipal General Hospital
City
Tokyo
ZIP/Postal Code
198-0042
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tsukuba Medical Center Hospital
City
Tsukuba-City
ZIP/Postal Code
305-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyobay Urayasu Ichikawa Medical Center
City
Urayasu-shi
ZIP/Postal Code
279-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sarawak General Hospital
City
Kuching
ZIP/Postal Code
93200
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Miri
City
Miri
ZIP/Postal Code
98000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University of Otago
City
Christchurch
ZIP/Postal Code
4710
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Hawkes Bay Hospital
City
Hastings
ZIP/Postal Code
4120
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Panorama MediClinic
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Tread Research
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Garda, RA
City
Johannesburg
ZIP/Postal Code
2192
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Dr J.M. Engelbrecht Trial Site
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Helderberg Research Institute
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Clinical Projects Research SA (PTY) LTD
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
E-DA Hospital
City
Kaohsiung
ZIP/Postal Code
82445
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Far Eastern Memorial Hospital
City
New Taipei
ZIP/Postal Code
22060
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Cheng Hsin General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114202
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Municipal Wanfang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiangmai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

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