Librexia - Atrial Fibrillation
Research type
Research Study
Full title
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
IRAS ID
1007736
Contact name
David Wright
Contact email
Sponsor organisation
Janssen -Cilag International NV
Eudract number
2022-501419-15
Clinicaltrials.gov Identifier
Research summary
This is a Phase 3 Active-Controlled study of a study drug called Milvexian for the prevention of cardioembolic (blood clots) events in patients with Atrial Fibrillation (AF). The study will compare the efficacy and safety of milvexian to apixaban for the prevention of strokes and embolism in patients with AF. AF is a condition whereby the upper chambers of the heartbeat rapidly and irregularly and out of sync with the lower chambers of the heart. This condition increases the risks of developing strokes, blood clots, heart failures and other cardiac related complications.
Milvexian is a part of a new class of anti-coagulants (blood thinners) that may have clinical benefits in patients with AF. Milvexian will act as an inhibitor of activated human coagulation Factor X1 which is a specialised protein involved in the pathway of coagulation in the human body. This mechanism will have the potential to reduce thrombin generation (a protein that activates platelets) to prevent thromboembolism (blood clots). Preliminary results show that Milvexian may meet an unmet need due to its safer mechanism compared to other therapies. Apixaban was chosen as the active comparator due to its efficacy and safety profile.
The study will include 3 periods: Screening /randomization , treatment period and follow-up period. Study duration will be approximately 4 years. This is to ensure an adequate data is collected in order to perform a more robust primary analysis, drawing definitive conclusions and obtaining sufficient safety information on the drug.
Study participants will be randomly assigned on a 1:1 ratio to receive either milvexian or apixaban. This means there will be a 50% chance to receive either milvexian +placebo or apixaban+placebo during this study.
Globally, the expected number of participants for this study is approximately 15,500. The Sponsor of the study is Janssen Cilag Inernational.REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0354
Date of REC Opinion
18 Sep 2023
REC opinion
Further Information Favourable Opinion