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FLORA-ACS: Rifaximin for High Platelet Reactivity in Post-ACS
NCT07203846Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Jan 2026
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Collegium Medicum of Nicolaus Copernicus University in Bydgoszcz
- Modality
- Small Molecules
- Drugs
- rifaximin
- Conditions
- acute coronary syndrome (ACS)
01
Overview
Phase 4, open-label, single-arm trial of rifaximin in acute coronary syndrome (ACS), sponsored by Collegium Medicum of Nicolaus Copernicus University in Bydgoszcz. Primary endpoints: Change in platelet reactivity in Multiplate and Achievement of platelet reactivity below HPR. Planned start Jan 2026; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
High platelet reactivity patients receiving rifaximin
Participants identified as having high platelet reactivity treated with oral rifaximin
03
Who it enrols
Patients with a history of ACS (1-12 months prior) on ticagrelor with high platelet reactivity (AUC > 46 U).
04
Endpoints
Primary
Change in platelet reactivity in Multiplate
Achievement of platelet reactivity below HPR
Secondary
Relative reduction in platelet reactivity
Achieving platelet reactivity below HPR in VerifyNow
Relative reduction in platelet reactivity in thromboelastography
Achieving platelet reactivity below HPR in thromboelastography
Changes in microbiome profile
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