The FLORA-ACS study aims to evaluate the relationship between dysbiosis and high platelet reactivity during treatment with ticagrelor in patients with a history of acute coronary syndromes and investigate the use of rifaximin to eliminate dysbiosis and thus provide effective antiplatelet treatment.
Between 18 and 80 years of age
History of acute coronary syndrome no sooner than 1 month and no later than 12 months prior to study inclusion
Current treatment with ticagrelor (90 mg orally twice a day)
High platelet reactivity assessed with multiple electrode aggregometry method (AUC of >46 U)
History of hypersensitivity to rifaximin or other rifamycin-derived agent
Ongoing treatment with rifamycins
Platelet count < 100×10^9/L or > 450×10^9/L
Treatment with antibiotics, probiotics, or glucocorticoids within 3 months prior to study inclusion
Single group
Rifaximin
DrugParticipants receiving a 7-day course of oral rifaximin 400 mg every 12 hours
Change in platelet reactivity in Multiplate
Relative reduction in platelet reactivity from baseline to post-intervention by \>10%, assessed with Multiplate analyzer (multiple electrode aggregometry)
Achievement of platelet reactivity below HPR
Achieving platelet reactivity below HPR in a patient with a higher baseline value, assessed with Multiplate analyzer (multiple electrode aggregometry)
Relative reduction in platelet reactivity
Relative reduction in platelet reactivity from baseline to post-intervention by \>10%, assessed with VerifyNow P2Y12 assay
Achieving platelet reactivity below HPR in VerifyNow
Achieving platelet reactivity below HPR in a patient with a higher baseline value, assessed with VerifyNow P2Y12 assay
Relative reduction in platelet reactivity in thromboelastography
Relative reduction in platelet reactivity from baseline to post-intervention by \>10%, assessed with Platelet Mapping assay (thromboelastography)
Achieving platelet reactivity below HPR in thromboelastography
Achieving platelet reactivity below HPR in a patient with a higher baseline value, assessed with Platelet Mapping assay (thrombelastography)
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Collegium Medicum w Bydgoszczy
Lead sponsor
Ministry of Science and Higher Education, Poland
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
