Clinical Trials List
2023-05-01 - 2027-06-24
Phase III
Recruiting13
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
-
Trial Applicant
IQVIA RDS Taiwan Ltd.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳嘉泓 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 謝東頤 無
- 陳仕軒 無
- 黃鈺茹 無
- HUNG SHENG LIN 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 鄭之光 無
- 江星逸 無
- 林宜穎 無
- 劉采薇 無
- 張寓智 無
- PO-LIN CHEN 無
- 張國軒 無
- 廖庭偉 無
- Hsiu-Chuan Wu 無
- 張庭瑜 無
- JYH-HONG LEE 無
- 謝珮甄 無
- Wei-Min Ho 無
- 徐守謙 無
- Chi-Hung Liu 無
- 張俊偉 無
- 洪濬 無
- 黃俞華 無
- 吳逸民 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chon-Haw Tsai 無
- Hung-Yu Huang 無
- Yi-Ting Hsu 無
- Hui-Chun Huang 無
- 林欽揚 無
- Chung-Hsiang Liu 無
- Ching-Hua Lu Lu 無
- Yu Ao 無
- Yi-Chien Yang 無
- 林欽揚 無
- Wei-Shih Huang 無
- Fu-Yu Lin 無
- Yu-Wan Yang 無
- Wei-Chung Wang 無
- Yuh-Cherng Guo 無
- Kuan-Fei Chen 無
- Ming-Kuei Lu 無
- 黃上芝 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李宗霖 無
- Pi-Shan Sung 無
- 王淳民 無
- 蘇慧真 無
- 林典佑 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution 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
The Estimated Number of Participants
-
Taiwan
204 participants
-
Global
15000 participants
