NCT07203846Not yet recruitingPhase 4
Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor
Modulation of Gut Microflora With Rifaximin to Reduce High Platelet Reactivity in Post-Acute Coronary Syndrome Patients on Ticagrelor (FLORA-ACS)
Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 25 Sept 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Diseases
- Coronary artery disease
- NCT number
- NCT07203846
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 1 Jan 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing treatment with rifamycins
- Treatment with antibiotics, probiotics, or glucocorticoids within 3 months prior to study inclusion
- Infection, including gastrointestinal infection, within a month prior to study inclusion
- Current use of specific medications (warfarin, glycoprotein IIb/IIIa inhibitors, immunosuppressants, bile acid sequestrants, antidiarrheal agents)
Other illness
- History of hypersensitivity to rifaximin or other rifamycin-derived agent
- History of gastrointestinal diseases such as inflammatory bowel disease, bowel obstruction, or gastrointestinal tumor
- History of Clostridium difficile infection
Lab values
- Platelet count \< 100×10\^9/L or \> 450×10\^9/L
Other
- Impaired liver function classified as Child-Pugh class B or C
- Hemodynamic instability
- Pregnancy or breastfeeding
- Patients considered by the investigator to be uncooperative
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiology Department, Dr. A. Jurasz University Hospital Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.