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 TIA (LIBREXIA-STROKE)

Clinical Trial Details

The purpose of this study is to see if an experimental drug, called milvexian in addition to standard of care, is safe and useful in reducing the risk of future ischemic stroke in subjects after ischemic stroke or transient ischemic attack compared to placebo (tablet with no active drug) in addition to standard of care. This research is important to future patients, as this knowledge may help doctors do a better job of preventing stroke in patients.

Experimental means that milvexian has not yet been approved by the U.S. Food and Drug Administration (FDA).

Participants will be randomized to receive either milvexian or placebo. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Study visits will take place at the start of the study, at 1-Month, 3-Months, 6-Months, 9-Months, and 12-Months, and will continue for every 3-months thereafter. Physical assessment and blood draws will be taken at study visits and some study visits may be completed virtually since they may not need a blood draw. Visits may include questionnaires asking the participant to rate their health and how they feel.

Total study participation will last up to 42 months.

Key Eligibility:

Open to men and women over the age of 40 who have been diagnosed with an acute ischemic stroke or high risk transient ischemic attack
Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event.
All female participants of childbearing potential must have a negative highly sensitive serum or urine test at screening.
Participants must not have a current intracranial hemorrhage.
The participant's index stroke or TIA must not be considered to have a cardio-embolic etiology.

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Carla Pisarro Sherman
(212) 746-6538
cas9149@med.cornell.edu

Primary Investigator(s)

Hooman Kamel, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2212025453

ClinicalTrials.gov:

NCT05702034

Status

Open to Enrollment

Age Group

Adult

Disease

Stroke