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Clinical Trials List

Protocol Number19767

NCT Number(ClinicalTrials.gov Identfier)NCT05686070

2022-12-05 - 2024-09-30

Phase III

Not yet recruiting2

Recruiting20

Terminated1

ICD-10I48.0

Paroxysmal atrial fibrillation

ICD-10I48.2

Chronic atrial fibrillation

ICD-10I48.91

Unspecified atrial fibrillation

ICD-9427.31

Atrial fibrillation

A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA

Trial Applicant

BAYER TAIWAN COMPANY LTD.
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator LIAN-YU LIN 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chern-En Chiang 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Yao Huang 無

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pao-Hsien Chu 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Cheng Hsieh 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉銘恩無

Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 周銘霆無

Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kuan-Cheng Chang 無

China Medical University Hospital

Co-Principal Investigator

林晏年無
吳宏彬無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 曹玄明無

National Yang-Ming University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 翁國昌無

Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王志鴻無

Hualien Tzu Chi Hospital

Co-Principal Investigator

張懷仁無
蔡文欽未分科

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林維祥無

Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃奭毓無

Cathay General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 夏建勳無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

黃宏凱無
廖英傑無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張盛雄無

MacKay Memorial Hospital

Co-Principal Investigator

李應湘無
郭任遠無
林書毅未分科
廖峰慶未分科
藍偉仁無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 方志元無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Kuo Lin 無

Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

Ming-Hsiung Hsieh 無
莊再庚無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李應湘無

MacKay Memorial Hospital

Co-Principal Investigator

藍偉仁無
郭任遠無
廖峰慶未分科
張盛雄未分科
林書毅無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蔡適吉無

Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

王子林無

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 郭風裕無

Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 王朝平無

E-DA Hospital

Co-Principal Investigator

洪尉欽無

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ting-Hsing Chao Division of Cardiovascular Diseases

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Prevention of Ischemic Stroke 、Acute Non-cardioembolic Ischemic Stroke、 High-risk Transient Ischemic Attack

Objectives

main Efficacy: Asundexian demonstrated to be superior (at least non-inferior) to apixaban in preventing stroke and systemic embolism in subjects at risk for stroke and with atrial fibrillation Safety: Asundexian demonstrated superiority to apixaban in participants with atrial fibrillation who were at risk for stroke as assessed by ISTH major bleeding Pure Clinical Benefit: Confirmation that asundexian is superior to apixaban in terms of benefits and risks secondary Efficacy: Compare the effects of asundexian and apixaban in terms of comprehensive and individual efficacy indicators Safety: Comparing asundexian with apixaban on composite and individual bleeding markers Pure clinical benefit: Comparing the benefits and risks of asundexian versus apixaban in terms of combined efficacy and safety metrics

Test Drug

AsundexianPlacebo (for Asundexian)ApixabanPlacebo (for Apixaban)

Active Ingredient

BAY 2433334
Placebo
Apixaban
Apixaban
Placebo

Dosage Form

tablet
tablet
tablet
tablet

Dosage

５０ｍｇ/tablet
NA
2.5mg/tablet
5mg/tablet
NA

Endpoints

Efficacy:
‧ Comprehensive indicator of stroke and systemic embolism*

safety:
‧ ISTH hemorrhage*

Pure clinical benefit:
‧ Comprehensive indicators of stroke, systemic embolism or ISTH massive bleeding*

* Time of first occurrence

Inclution Criteria

Inclusion Criteria:

Participants must be ≥ 18 years of age
Acute non-cardioembolic stroke or high-risk TIA
Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct

Exclusion Criteria

Exclusion Criteria:

Ischemic stroke ≤ 7 days before the index event
Index stroke following procedures or strokes due to other rare causes
History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or other cardioembolic source of stroke requiring anticoagulation

The Estimated Number of Participants

Taiwan

716 participants
Global

20454 participants