ongoing

The objective of the INVICTUS study is to determine if:

1. In patients with rheumatic valvular heart disease (RVHD) and who are in atrial fibrillation or flutter (AF/flutter) and have other stroke risk factors, rivaroxaban is non-inferior to vitamin K antagonists (VKAs) for prevention of stroke or systemic embolism.

2. In patients with RVHD, either with AF/flutter but unsuitable for VKA therapy, or with sinus rhythm but with high risk, rivaroxaban is superior to aspirin for prevention of stroke or systemic embolism.

Primary endpoints:

Stroke and systemic embolism.

This research program is comprised of, running concurrently:

  • Two randomized, parallel group, open-label clinical trials, INVICTUS-RCT (4565 participants total).
  • A multi-center INVICTUS-Registry for RVHD (17,000 participants).
Study Type

Interventional - Drug

Study Design

Open-label RCT; Registry

NO. of Countries

27

NO. of Sites

140

NO. of Participants

4565 RCT; 17000 Registry

Study Period

2016-2021

Sponsor

PHRI

Bayer

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