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Research > Stroke & Cognition

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PACIFIC-Stroke

Official Title

Study program of the oral FXIa inhibitor BAY 2433334 – Non-cardioembolic Stroke study

Status

Ongoing

Overview

This study will assess the dose-response of BAY 2433334 in order to determine the dose that is efficacious and safe and that can be used in a Phase 3 study in the same indication. Current guidelines recommend antiplatelet therapy for patients after a non-cardioembolic stroke / transient ischemic attack (TIA).

The inhibition of FXIa on top of antiplatelet therapy is expected to lead to a benefit regarding secondary prevention of stroke combined with no or only minimal increase in bleeding and especially no increase in major bleeding.

Study Design

Randomized, placebo-controlled, double-blind, dose-finding Phase 2 study. Parallel group treatment study with four arms that is participant and investigator blinded.

Primary Endpoint

  • To assess the dose response of 3 different doses of BAY 2433334 compared to placebo in reducing the composite of symptomatic ischemic strokes and covert brain infarcts detected by MRI as well as other cerebro- and cardiovascular endpoints in participants with an acute non-cardioembolic ischemic stroke and who are treated with antiplatelet therapy.
  • To evaluate whether the incidence of bleeding for BAY 2433334 is similar compared to placebo in participants with an acute non-cardioembolic ischemic stroke and who are treated on top of antiplatelet therapy.

Number of Patients

1800

Number of Sites

250

Number of Countries

25

Study Period

2019-2021

Principal Investigator

Robert Hart

Program Manager

Ellison Themeles

Research Coordinator

Amanda Taylor

Collaborators

Bayer AG