Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor

ConditionsACS - Acute Coronary Syndrome Ticagrelor Microbiota Platelet Aggregation Myocardial Infarction (MI)Blood Platelets Drug Effects Platelet Aggregation Inhibitors Drug Resistance Platelet Function Tests Dysbiosis Anti-Bacterial Agents Rifaximin

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-80

SponsorCollegium Medicum w Bydgoszczy

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

Rifaximin

Treatment groups

50 Participants

are divided into 1 treatment group

Sponsors and collaborators

Collegium Medicum w Bydgoszczy

Lead sponsor

Ministry of Science and Higher Education, Poland

Collaborator

Source ClinicalTrials.gov