drugset / Trial / NCT03766581
A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.
Timeline
- Start
- 2019-01-27
- Primary completion
- 2022-03-31
- Completion
- 2022-03-31
Publications
- Sharma M, Molina CA, Toyoda K, Bereczki D, Bangdiwala SI, Kasner SE, Lutsep HL, Tsivgoulis G, Ntaios G, Czlonkowska A, Shuaib A, Amarenco P, Endres M, Yoon BW, Tanne D, Toni D, Yperzeele L, von Weitzel-Mudersbach P, Sampaio Silva G, Avezum A, Dawson J, Strbian D, Tatlisumak T, Eckstein J, Ameriso SF, Weber JR, Sandset EC, Goar Pogosova N, Lavados PM, Arauz A, Gailani D, Diener HC, Bernstein RA, Cordonnier C, Kahl A, Abelian G, Donovan M, Pachai C, Li D, Hankey GJ. Safety and efficacy of factor XIa inhibition with milvexian for secondary stroke prevention (AXIOMATIC-SSP): a phase 2, international, randomised, double-blind, placebo-controlled, dose-finding trial. Lancet Neurol. 2024 Jan;23(1):46-59. doi: 10.1016/S1474-4422(23)00403-9.
- Whiteson HZ, Frishman WH. Factor XI/XIa Inhibitors: A New Approach to Anticoagulation. Cardiol Rev. 2025 Jul-Aug 01;33(4):306-311. doi: 10.1097/CRD.0000000000000624. Epub 2023 Dec 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Milvexian | Small molecule | 25 mg | Oral |
| Subject | Milvexian | Small molecule | 50 mg | Oral |
| Subject | Milvexian | Small molecule | 100 mg | Oral |
| Subject | Milvexian | Small molecule | 200 mg | Oral |
| Background | Aspirin | Small molecule | 100 mg | Oral |
| Background | Clopidogrel | Small molecule | 75 mg | Oral |