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Clinical Trials List

Protocol Number20604
NCT Number(ClinicalTrials.gov Identfier)NCT05686070
Active

2023-01-16 - 2025-08-30

Phase III

Not yet recruiting6

Recruiting17

ICD-10I63.40

Cerebral infarction due to embolism of unspecified cerebral artery

ICD-10I63.411

Cerebral infarction due to embolism of right middle cerebral artery

ICD-10I63.412

Cerebral infarction due to embolism of left middle cerebral artery

ICD-10I63.419

Cerebral infarction due to embolism of unspecified middle cerebral artery

ICD-10I63.421

Cerebral infarction due to embolism of right anterior cerebral artery

ICD-10I63.422

Cerebral infarction due to embolism of left anterior cerebral artery

ICD-10I63.429

Cerebral infarction due to embolism of unspecified anterior cerebral artery

ICD-10I63.431

Cerebral infarction due to embolism of right posterior cerebral artery

ICD-10I63.432

Cerebral infarction due to embolism of left posterior cerebral artery

ICD-10I63.439

Cerebral infarction due to embolism of unspecified posterior cerebral artery

ICD-10I63.441

Cerebral infarction due to embolism of right cerebellar artery

ICD-10I63.442

Cerebral infarction due to embolism of left cerebellar artery

ICD-10I63.449

Cerebral infarction due to embolism of unspecified cerebellar artery

ICD-10I63.49

Cerebral infarction due to embolism of other cerebral artery

ICD-9434.11

Cerebral embolism with cerebral infarction

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

    2026/02/01

Investigators and Locations

Principal Investigator 陳安芝 Division of Neurology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Hung Liu Division of Neurology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳仕軒 Division of Neurology
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 A-Ching Chao Division of Neurology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 唐志威 Division of Neurology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 孫瑜 Division of Neurology
En Chu Kong Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 連立明 Division of Neurology
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳大成 Division of Neurology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator SUNG-CHUN TANG Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李怡蓁 Division of Neurology
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator PO-LIN CHEN Division of Neurology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李怡慧 Division of Neurology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Lung Chan Division of Neurology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chung-Hsiang Liu Division of Neurology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 林清煌 Division of Neurology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsing-Yu Weng Division of Neurology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 林雅如 無
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 周中興 Division of Neurology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 鄭又禎 Division of Neurology
Fu Jen Catholic University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Pi-Shan Sung Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳明修 Division of Neurology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 葉篤學醫師 Division of Neurology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃雯怡醫師 Division of Neurology
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Prevention of Ischemic Stroke

Objectives

Primary efficacy: To evaluate whether the oral FXIa inhibitor asundexian is superior to placebo in reducing the incidence of ischemic stroke in patients with acute noncardiac ischemic stroke or high-risk TIA in the setting of background antiplatelet therapy. Key Safety: Comparing the incidence of ISTH major bleeding with asundexian versus placebo in patients with acute noncardiac ischemic stroke or high-risk TIA in the setting of background antiplatelet therapy Secondary efficacy: To assess whether asundexian is superior to placebo in reducing the incidence of combined and individual efficacy trial measures in the context of background antiplatelet therapy Secondary Safety: Individual Bleeding Trial Endpoints Comparing Asundexian and Placebo Under Antiplatelet Therapy Pure Clinical Benefit: Further comparison of the benefits and risks of asundexian versus placebo across combined efficacy and safety trial measures

Test Drug

asundexianPlacebo

Active Ingredient

asundexian
Placebo

Dosage Form

tablet
tablet

Dosage

50mg/tablet
NA

Endpoints

first occurrence time
Efficacy: Ischemic Stroke
Safety: ISTH major bleeding

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

    378 participants

  • Global

    13000 participants

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