Status:
NOT_YET_RECRUITING
Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor
Lead Sponsor:
Collegium Medicum w Bydgoszczy
Collaborating Sponsors:
Ministry of Science and Higher Education, Poland
Conditions:
ACS - Acute Coronary Syndrome
Ticagrelor
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 investi...
Detailed Description
A research hypothesis has been formulated indicating dysbiosis of the gut microbiota as a possible cause of high platelet reactivity (HPR) during treatment with an antiplatelet agent, ticagrelor, in p...
Eligibility Criteria
Inclusion
- 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 \< 100×10\^9/L or \> 450×10\^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
Exclusion
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07203846
Start Date
January 1 2026
End Date
June 30 2027
Last Update
October 2 2025
Active Locations (1)
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1
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Cuiavian-Pomeranian, Poland, 85-094