Back to resultsA Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE (LIBREXIA-STROK)
Primary Purpose
Ischemic Stroke; Ischemic Attack, Transient
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Milvexian
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke; Ischemic Attack, Transient
Eligibility Criteria
Inclusion Criteria: Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of randomization, or acute, ischemic brain lesion determined by standard-of-care neuroimaging, or participant underwent thrombolysis or thrombectomy, or transient ischemic attack (TIA): acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (example, computed tomography (CT) scan or magnetic resonance imaging (MRI), performed as part of standard medical practice), and ABCD2 Score greater than or equal to (>=) 6 Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event. Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention Willing and able to adhere to the lifestyle restrictions specified in this protocol Exclusion Criteria: Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (>) 1 year prior with adequate treatment The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial [TOAST] Other Determined Etiology), based on local standard-of-care investigations Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis Known allergies, hypersensitivity, or intolerance to milvexian or its excipients
Sites / Locations
- Glendale Adventist Medical CenterRecruiting
- UC Irvine Healthcare CenterRecruiting
- Long Beach MemorialRecruiting
- Harbor Ucla Medical CenterRecruiting
- University of ColoradoRecruiting
- MedStar Health Research InstituteRecruiting
- Sacred Heart HospitalRecruiting
- Sarasota Memorial HospitalRecruiting
- Insight Hospital and Medical Center ChicagoRecruiting
- Javon Bea HospitalRecruiting
- Prairie Education & Research CooperativeRecruiting
- IU Health Methodist HospitalRecruiting
- Community Hospital Cardiovascular ResearchRecruiting
- Ascension via Christi ResearchRecruiting
- Pikeville Medical CenterRecruiting
- Sinai Hospital of BaltimoreRecruiting
- Comprehensive Neurology ServicesRecruiting
- Detroit Clinical Research CenterRecruiting
- Memorial Institute for Neurosciences and Multiple SclerosisRecruiting
- University of Nebraska Medical CenterRecruiting
- Jersey Shore University Medical CenterRecruiting
- Rutgers New Jersey Medical SchoolRecruiting
- Lincoln HospitalRecruiting
- Mercy HospitalRecruiting
- Weill Cornell Medical CollegeRecruiting
- Guilford Neurologic AssociatesRecruiting
- The Ohio State UniversityRecruiting
- Ascension Medical Group - St. John Clinic Infectious DiseaseRecruiting
- Abington Memorial HospitalRecruiting
- Temple University HospitalRecruiting
- Einstein Medical CenterRecruiting
- TriStar Skyline Medical CenterRecruiting
- Saint Thomas HealthRecruiting
- Seton Heart InstituteRecruiting
- Neurology Consultants of Dallas, PARecruiting
- Sentara Medical GroupRecruiting
- Winchester Medical CenterRecruiting
- Multiprofile Hospital for Active Treatment PulsRecruiting
- MHAT Sveti Ivan RilskiRecruiting
- MHAT Avis - Medica OODRecruiting
- UMHAT KaspelaRecruiting
- Fakultni nemocnice BrnoRecruiting
- Nemocnice JihlavaRecruiting
- Nemocnice Pisek, a.s.Recruiting
- Hopital Raymond PoincareRecruiting
- Centre HospitalierRecruiting
- Hôpital Bichat - Claude BernardRecruiting
- Klinikum Altenburger Land GmbHRecruiting
- Asklepios Klinik Nord - HeidbergRecruiting
- Universitaetsklinikum TuebingenRecruiting
- Azienda Unita Sanitaria Locale Umbria 1 Ospedale di Citta di CastelloRecruiting
- Azienda Ospedaliera Universitaria Integrata VeronaRecruiting
- Toyota Memorial HospitalRecruiting
- Steel Memorial Yawata HospitalRecruiting
- Saiseikai Fukuoka General HospitalRecruiting
- National Hospital Organization Kyushu Medical CenterRecruiting
- Takayama Red Cross HospitalRecruiting
- Tokai University Hachioji HospitalRecruiting
- NHO Higashihiroshima Medical CenterRecruiting
- National Hospital Organization Kanazawa Medical CenterRecruiting
- Fukuoka Tokushukai HospitalRecruiting
- Nagoya Tokushukai General HospitalRecruiting
- National Hospital Organization Fukuoka Higashi Medical CenterRecruiting
- Japanese Red Cross Kumamoto HospitalRecruiting
- Tenjinkai Shin Koga ClinicRecruiting
- Tokushukai Matsubara Tokushukai HospitalRecruiting
- NHO Nagoya Medical CenterRecruiting
- National Hospital Organization Osaka National HospitalRecruiting
- Konankai Konan HospitalRecruiting
- Kanmon Medical CenterRecruiting
- NTT Medical Center TokyoRecruiting
- NHO Toyohashi Medical CenterRecruiting
- Sanyudo HospitalRecruiting
- Seoul National University HospitalRecruiting
- Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny w ChelmieRecruiting
- 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w LublinieRecruiting
- Zespol Opieki Zdrowotnej w Skarzysku-Kamiennej Szpital Powiatowy im. M.Curie-SklodowskiejRecruiting
- KO-MED Centra Kliniczne StaszowRecruiting
- Iatros InternationalRecruiting
- Garda, RARecruiting
- Dr J.M. Engelbrecht Trial SiteRecruiting
- Drs Sarvan and MoodleyRecruiting
- Clinical Projects Research SA (PTY) LTDRecruiting
- Hosp. Del MarRecruiting
- Hosp. de La Santa Creu I Sant PauRecruiting
- Hosp. Reina SofiaRecruiting
- Hosp. Clinico San CarlosRecruiting
- Hosp. Clinico Univ. de ValenciaRecruiting
- Hosp. Clinico Univ. de ValladolidRecruiting
- Taipei Medical University Shuang Ho HospitalRecruiting
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Milvexian
Placebo
Arm Description
Participants after an acute ischemic stroke or high-risk transient ischemic attack (TIA) who are receiving antiplatelet therapy standard-of-care (SAPT [single antiplatelet therapy] or DAPT [dual antiplatelet therapy]) will receive milvexian orally twice daily.
Participants after an acute ischemic stroke or high-risk TIA who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) will receive placebo orally twice daily.
Outcomes
Primary Outcome Measures
Time to First Occurrence of Ischemic Stroke
Time to first occurrence of ischemic stroke will be reported.
Secondary Outcome Measures
Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke
Time to first occurrence of any component of the composite of CVD, MI, or ischemic stroke will be reported.
Time to First Occurrence of Ischemic Stroke
Time to first occurrence of ischemic stroke in the first 90 days will be reported.
Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE)
Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of (CVD), myocardial infarction (MI), ischemic stroke, major adverse limb events (MALE), symptomatic pulmonary embolism (PE) or deep vein thrombosis (DVT).
Full Information
NCT ID
NCT05702034
First Posted
January 19, 2023
Last Updated
September 12, 2023
Sponsor
Janssen Research & Development, LLC
Collaborators
Bristol Myers Squibb Company (BMS)
1. Study Identification
Unique Protocol Identification Number
NCT05702034
Brief Title
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
Acronym
LIBREXIA-STROK
Official Title
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
November 11, 2026 (Anticipated)
Study Completion Date
December 9, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Bristol Myers Squibb Company (BMS)
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 whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke; Ischemic Attack, Transient
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Milvexian
Arm Type
Experimental
Arm Description
Participants after an acute ischemic stroke or high-risk transient ischemic attack (TIA) who are receiving antiplatelet therapy standard-of-care (SAPT [single antiplatelet therapy] or DAPT [dual antiplatelet therapy]) will receive milvexian orally twice daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants after an acute ischemic stroke or high-risk TIA who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) will receive placebo orally twice daily.
Intervention Type
Drug
Intervention Name(s)
Milvexian
Other Intervention Name(s)
JNJ-70033093, BMS-986177
Intervention Description
Milvexian will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered orally
Primary Outcome Measure Information:
Title
Time to First Occurrence of Ischemic Stroke
Description
Time to first occurrence of ischemic stroke will be reported.
Time Frame
Up to global targeted endpoint date (approximately 41 months)
Secondary Outcome Measure Information:
Title
Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke
Description
Time to first occurrence of any component of the composite of CVD, MI, or ischemic stroke will be reported.
Time Frame
Up to global targeted endpoint date (approximately 41 months)
Title
Time to First Occurrence of Ischemic Stroke
Description
Time to first occurrence of ischemic stroke in the first 90 days will be reported.
Time Frame
Up to Day 90
Title
Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE)
Description
Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of (CVD), myocardial infarction (MI), ischemic stroke, major adverse limb events (MALE), symptomatic pulmonary embolism (PE) or deep vein thrombosis (DVT).
Time Frame
Up to global targeted endpoint date (approximately 41 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of randomization, or acute, ischemic brain lesion determined by standard-of-care neuroimaging, or participant underwent thrombolysis or thrombectomy, or transient ischemic attack (TIA): acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (example, computed tomography (CT) scan or magnetic resonance imaging (MRI), performed as part of standard medical practice), and ABCD2 Score greater than or equal to (>=) 6
Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event.
Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care
A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention
Willing and able to adhere to the lifestyle restrictions specified in this protocol
Exclusion Criteria:
Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (>) 1 year prior with adequate treatment
The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation
The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial [TOAST] Other Determined Etiology), based on local standard-of-care investigations
Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage
Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis
Known allergies, hypersensitivity, or intolerance to milvexian or its excipients
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
Glendale Adventist Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Irvine Healthcare Center
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Name
Long Beach Memorial
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Name
Harbor Ucla Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
MedStar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Name
Insight Hospital and Medical Center Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Individual Site Status
Recruiting
Facility Name
Javon Bea Hospital
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114
Country
United States
Individual Site Status
Recruiting
Facility Name
Prairie Education & Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Individual Site Status
Recruiting
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Community Hospital Cardiovascular Research
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension via Christi Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Name
Pikeville Medical Center
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41537
Country
United States
Individual Site Status
Recruiting
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Neurology Services
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Individual Site Status
Recruiting
Facility Name
Detroit Clinical Research Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Institute for Neurosciences and Multiple Sclerosis
City
Owosso
State/Province
Michigan
ZIP/Postal Code
48867
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Individual Site Status
Recruiting
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Name
Lincoln Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14220
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Guilford Neurologic Associates
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Medical Group - St. John Clinic Infectious Disease
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Recruiting
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Name
Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Individual Site Status
Recruiting
Facility Name
TriStar Skyline Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37207
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Thomas Health
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Individual Site Status
Recruiting
Facility Name
Seton Heart Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology Consultants of Dallas, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Sentara Medical Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
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
Multiprofile Hospital for Active Treatment Puls
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT Sveti Ivan Rilski
City
Gorna Oryahovitsa
ZIP/Postal Code
5100
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT Avis - Medica OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Kaspela
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
636 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Nemocnice Jihlava
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Nemocnice Pisek, a.s.
City
Písek
ZIP/Postal Code
397 23
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Name
Klinikum Altenburger Land GmbH
City
Altenburg
ZIP/Postal Code
04600
Country
Germany
Individual Site Status
Recruiting
Facility Name
Asklepios Klinik Nord - Heidberg
City
Hamburg
ZIP/Postal Code
22417
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Azienda Unita Sanitaria Locale Umbria 1 Ospedale di Citta di Castello
City
Perugia
ZIP/Postal Code
06012
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Toyota Memorial Hospital
City
Aichi
ZIP/Postal Code
471-8513
Country
Japan
Individual Site Status
Recruiting
Facility Name
Steel Memorial Yawata Hospital
City
Fukuoka
ZIP/Postal Code
805-0050
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takayama Red Cross Hospital
City
Gifu
ZIP/Postal Code
506-0025
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokai University Hachioji Hospital
City
Hachioji
ZIP/Postal Code
192-0032
Country
Japan
Individual Site Status
Recruiting
Facility Name
NHO Higashihiroshima Medical Center
City
Higashihiroshima-shi
ZIP/Postal Code
739-0041
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kanazawa Medical Center
City
Ishikawa
ZIP/Postal Code
920-8650
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
Nagoya Tokushukai General Hospital
City
Kasugai-shi
ZIP/Postal Code
487-0016
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Fukuoka Higashi Medical Center
City
Koga
ZIP/Postal Code
811-3195
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tenjinkai Shin Koga Clinic
City
Kurume-shi
ZIP/Postal Code
830-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokushukai Matsubara Tokushukai Hospital
City
Matsubara-shi
ZIP/Postal Code
580-0032
Country
Japan
Individual Site Status
Recruiting
Facility Name
NHO Nagoya Medical Center
City
Nagoya-shi
ZIP/Postal Code
460-0001
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
Konankai Konan Hospital
City
Sendai-shi
ZIP/Postal Code
982-8523
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanmon Medical Center
City
Shimonoseki-shi
ZIP/Postal Code
752-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
NTT Medical Center Tokyo
City
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Individual Site Status
Recruiting
Facility Name
NHO Toyohashi Medical Center
City
Toyohasi-shi
ZIP/Postal Code
440-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sanyudo Hospital
City
Yonezawa-shi
ZIP/Postal Code
992-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny w Chelmie
City
Chelmie
ZIP/Postal Code
22-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie
City
Lublin
ZIP/Postal Code
20-049
Country
Poland
Individual Site Status
Recruiting
Facility Name
Zespol Opieki Zdrowotnej w Skarzysku-Kamiennej Szpital Powiatowy im. M.Curie-Sklodowskiej
City
Skarzysko-Kamienna
ZIP/Postal Code
26-110
Country
Poland
Individual Site Status
Recruiting
Facility Name
KO-MED Centra Kliniczne Staszow
City
Staszow
ZIP/Postal Code
28-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Iatros International
City
Bloemfontein
ZIP/Postal Code
9324
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
Drs Sarvan and Moodley
City
Tongaat
ZIP/Postal Code
4399
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
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Valladolid
City
Valladolid
ZIP/Postal Code
470003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
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 an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
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