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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05757869




Registration number
NCT05757869
Ethics application status
Date submitted
24/02/2023
Date registered
7/03/2023
Date last updated
22/05/2024

Titles & IDs
Public title
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
Scientific title
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation
Secondary ID [1] 0 0
70033093AFL3002
Secondary ID [2] 0 0
CR109220
Universal Trial Number (UTN)
Trial acronym
LIBREXIA-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Milvexian
Treatment: Drugs - Apixaban
Treatment: Drugs - Placebo
Treatment: Drugs - Apixaban Placebo

Experimental: Milvexian - Participants will receive milvexian 100 milligrams (mg) orally, twice daily and placebo that matches apixaban beginning on Day 1 through end of treatment (EOT). Participants after the EOT visit may have an option to receive open-label apixaban at the appropriate dose (5 mg or 2.5 mg, twice daily), for which the sponsor provides a 30-day supply.

Active Comparator: Apixaban - Participants will receive a placebo that matches milvexian and a capsule containing apixaban 5 mg or 2.5 mg orally, twice daily. Participants after the EOT visit may have an option to receive open-label apixaban (5 mg or 2.5 mg, twice daily) at the appropriate dose, for which the sponsor provides a 30-day supply.


Treatment: Drugs: Milvexian
Milvexian will be administered orally.

Treatment: Drugs: Apixaban
Apixaban will be administered orally.

Treatment: Drugs: Placebo
Milvexian matching milvexian placebo will be administered orally.

Treatment: Drugs: Apixaban Placebo
Apixaban matching apixaban placebo will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Time to the First Occurrence of International Society of Thrombosis and Hemostasis (ISTH) Major Bleeding
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Time to the First Occurrence of the Composite of ISTH Major and Clinically Relevant Non-major (CRNM) Bleeding
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Time to the First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, and Non-CNS Systemic Embolism
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Time to CV Death
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Time to the First Occurrence of Composite Endpoint of All-cause Death, MI, Stroke and Non-CNS Systemic Embolism
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Time to the First Occurrence of Composite Endpoint of CV Death, MI, Stroke, Acute Limb Ischemia (ALI), and Urgent Hospitalization for Vascular cause of Ischemic Nature
Timepoint [6] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
- Minimum age of 18 years

- Medically stable and appropriate for chronic antithrombotic treatment

- Atrial fibrillation eligible to receive anticoagulation

- Participant must satisfy one or both of the following categories of risk factors (a or
b): a) one or more of the following risk factors: i) age greater than or equal to 75
years, ii) history of any type of stroke including symptomatic stroke of any kind. b)
two or more of the following risk factors: i) age between 65 and 74 years, ii)
hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart
failure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Hemodynamically significant valve disease or those with valve disease that will
potentially require surgical valve replacement during the study

- Any condition other than AF that requires chronic anticoagulation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/05/2027
Actual
Sample size
Target
15500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Advara HeartCare Wesley - Brisbane
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Peninsula Heart Center - Frankston
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [6] 0 0
GenesisCare Joondalup-Shenton House - Joondalup
Recruitment hospital [7] 0 0
Novatrials - Kotara
Recruitment hospital [8] 0 0
GenesisCare - Leabrook
Recruitment hospital [9] 0 0
Core Research Group - Milton
Recruitment hospital [10] 0 0
Brisbane Health Connect - Tarragindi
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
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4066 - Brisbane
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2139 - Concord
Recruitment postcode(s) [4] 0 0
3199 - Frankston
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4029 - Herston
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6027 - Joondalup
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2289 - Kotara
Recruitment postcode(s) [8] 0 0
5068 - Leabrook
Recruitment postcode(s) [9] 0 0
4064 - Milton
Recruitment postcode(s) [10] 0 0
4121 - Tarragindi
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Wigan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate if milvexian is at least as effective as apixaban
for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic
embolism.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05757869
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05757869