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Photo for AXIOMATIC-SSP

AXIOMATIC-SSP

Official Title

A global, Phase 2, randomized, double-blind, placebo-controlled, response-adaptive dose-ranging study of BMS-986177, an oral factor XIa inhibitor, for the prevention of new ischemic stroke or new covert brain infarction in patients receiving aspirin and clopidogrel following acute ischemic stroke or transient ischemic attack (TIA).

Status

Ongoing

Overview

AXIOMATIC SSP is a phase II dose finding trial of a FXIa inhibitor (BMS 986177) added to aspirin and clopidogrel in patients with TIA or minor stroke examining the effect on recurrent stroke. The primary endpoint is a composite of symptomatic stroke and incident covert infarct on MRI imaging during the treatment period.

Study Design

Global, Phase 2, double-blind, placebo-controlled, response-adaptive randomization (RAR) dose-ranging trial.

Primary Endpoint

Composite of new ischemic stroke and new covert brain infarction (FLAIR + DWI) during the treatment period detected by MRI at 90 days.

Number of Patients

3000

Number of Countries

25

Study Period

2019-2021

Principal Investigator

Mike Sharma

Program Manager

Brandi Meeks

Research Coordinator

Jodi Miller

Collaborators

Bristol-Myers Squibb and Janssen, LP