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Clinical Trials List

Protocol Number70033093AFL3002
Active

2023-04-13 - 2027-05-05

Phase III

Recruiting12

ICD-10I48.0

Paroxysmal atrial fibrillation

ICD-10I48.2

Chronic atrial fibrillation

ICD-10I48.91

Unspecified atrial fibrillation

ICD-9427.31

Atrial fibrillation

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Janssen Research & Development, LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 黃啟宏 Division of Cardiovascular Diseases
Cathay General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳清埤 Division of Cardiovascular Diseases
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yen-Wen Wu Division of Cardiovascular Diseases
Far Eastern Memorial Hospital

Co-Principal Investigator

  • 許榮城 Division of Cardiovascular Diseases
  • 林恆旭 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-I Yeh Division of Cardiovascular Diseases
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tzung-Dau Wang Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林維祥 Division of Cardiovascular Diseases
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李統立 Division of Cardiovascular Diseases
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kang-Ling Wang Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pei-Ying Pai Division of Cardiovascular Diseases
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Kuo Lin
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Atrial Fibrillation

Objectives

To evaluate if milvexian is non-inferior to apixaban for the composite of stroke and non-CNS systemic embolism

Test Drug

tablet

Active Ingredient

Milvexian

Dosage Form

110

Dosage

100mg/tablet

Endpoints

Time to the first occurrence of composite
endpoint of stroke and non-CNS systemic
embolism

Inclution Criteria

2. Medically stable and appropriate for chronic antithrombotic treatment on the basis of
physical examination, medical history, vital signs, and clinical laboratory tests performed
as part of standard of care or at screening. Any abnormalities in physical examination,
medical history or vital signs must be consistent with the underlying illness in the study
population. If the results of the serum chemistry panel, hematology, or urinalysis are outside
the normal reference ranges, the participant may be included only if the investigator judges
the abnormalities or deviations from normal to be not clinically significant or to be
appropriate and reasonable for the population under study. This determination must be
recorded in the participant's source documents and initialed by the principal investigator or
appropriately qualified designee.
3. Atrial fibrillation or flutter, paroxysmal or sustained not due to a reversible cause, and
eligible to receive anticoagulation therapy:
i. Criterion modified per Amendment 1
i.1. Criterion modified per Amendment 2
i.2. Atrial fibrillation or atrial flutter must be documented by ECG evidence
(eg, 12-lead ECG, rhythm strip, Holter, or pacemaker interrogation) within
1 year of randomization.
ii. If electrical cardioversion or ablation is planned, the investigator plans to treat the
patient with anticoagulation for the duration of the trial.

Exclusion Criteria

3. A prior disabling stroke defined by a current mRS of ≥3. Refer to mRS scoring in Study
Specific Materials.
4. Criterion modified per Amendment 1
4.1. Hemodynamically significant valve disease or those with valve disease that will
potentially require surgical valve replacement during the study as determined by the
investigator
5. Criterion modified per Amendment 2
5.1 Any condition other than AF that requires chronic anticoagulation at the discretion of
the investigator and/or local guidelines, such as mechanical heart valves. However,
participants with an indication for chronic antiplatelet therapy after placement of a bioprosthetic non-mechanical valve (eg, transcatheter aortic valve replacement [TAVR])
do not satisfy this exclusion criterion and are eligible for study participation. In
addition, apixaban, like other oral anticoagulants (DOACs), is not recommended for
patients with a history of thrombosis who are diagnosed with antiphospholipid
syndrome. As apixaban serves as the comparator in the study, the investigator should
consult the local labeling information in determining the suitability of a participant for
study participation.
6. Criterion modified per Amendment 2
6.1 Any condition that, in the opinion of the investigator, contraindicates anticoagulant
therapy, or would, with anticoagulation, have an unacceptable risk of bleeding, or
would interfere with the study endpoint assessments, eg, large cerebral infarct volume,
active/recent major bleeding, major surgery ≤30 days prior to randomization, known
bleeding diathesis, eg, von Willebrand’s Disease.
7. Known presence of atrial myxoma or left ventricular thrombus
8. Active endocarditis

The Estimated Number of Participants

  • Taiwan

    200 participants

  • Global

    20000 participants

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