Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patien… (NCT07203846) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor
Poland50 participantsStarted 2026-01-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria:
* 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)
* Provision of informed consent prior to any study procedures
Exclusion criteria:
* History of hypersensitivity to rifaximin or other rifamycin-derived agent
* Ongoing treatment with rifamycins
* Platelet count \< 100Ă—10\^9/L or \> 450Ă—10\^9/L
* Treatment with antibiotics, probiotics, or glucocorticoids within 3 months prior to study inclusion
* History of gastrointestinal diseases such as inflammatory bowel disease, bowel obstruction, or gastrointestinal tumor
* Infection, including gastrointestinal infection, within a month prior to study inclusion
* History of Clostridium difficile infection
* Current use of specific medications (warfarin, glycoprotein IIb/IIIa inhibitors, immunosuppressants, bile acid sequestrants, antidiarrheal agents)
* Impaired liver function classified as Child-Pugh class B or C
* Hemodynamic instability
* Pregnancy or breastfeeding
* Patients considered by the investigator to be uncooperative