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Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

Study acronym: ROXI-ATLAS
StatusRecruiting
PhasePhase 2
Started2025-10-20
View on ClinicalTrials.gov ↗

Amendment history

2026-09-29
Trial sites expanded: 81 → 84 locations
2026-08-18
Study Status, Contacts/Locations v19
Trial sites expanded: 77 → 81 locations
Trial sites expanded: 74 → 77 locations
2026-08-03
Study Status, Contacts/Locations v18
Trial sites expanded: 70 → 74 locations
2026-07-22
Study Status, Contacts/Locations v17
Trial sites expanded: 59 → 70 locations
2026-07-07
Study Status, Contacts/Locations v16
Trial sites expanded: 48 → 59 locations
2026-06-16
Study Status, Contacts/Locations v15
Trial sites expanded: 45 → 48 locations
2026-05-26
Study Status, Arms and Interventions, Contacts/Locations v14
Study sites45 entries, revised
Profound Research, LLCMillennium Cardiology
2026-05-08
Study Status, Eligibility, Contacts/Locations v13
Trial sites expanded: 42 → 45 locations
Eligibility criteria-79 characters
[...] enrichment criteria as described in the protocol Must have aan Prothrombin Time/International Normalization Ratio (PT/INR) <2.5 at the time of randomization if taking warfarin or [...] an ischemic stroke within 2 days prior to randomization Has Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m^2 within 1430 days prior to randomization or on dialysis or expected to b [...]
2026-04-22
Study Status, Contacts/Locations v12
Study sites41→42
2026-04-07
Study Status, Contacts/Locations v11
Trial sites expanded: 37 → 41 locations
2026-03-17
Study Status, Contacts/Locations v10
Study sites34→37
2026-03-03
Study Status, Contacts/Locations v9
Study sites30→34
2026-02-18
Study Status, Contacts/Locations v8
Study sites25→30
2026-02-04
Study Status, Contacts/Locations v7
Study sites21→25
2026-01-22
Study Status, Contacts/Locations v6
Study sites20→21
2026-01-06
Study Status, Contacts/Locations v5
Study sites15→20
2025-12-16
Study Status, Contacts/Locations v4
Study sites13→15
2025-12-08
Study Status, Contacts/Locations v3
Study sites5→13
2025-11-18
Study Status, Contacts/Locations v2
Study sites2→5
2025-10-30
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-04-26→2027-02-09
Completion date2027-04-26→2027-04-21
Start dateestimated 2025-10-21→confirmed 2025-10-20
Study sites0→2
2025-09-09
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
Atrial Fibrillation
1,126 trials monitored
See 49 trials at risk
This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots. The study is looking at several other research questions, including: * What side effects may happen from taking REGN7508 or REGN9933 * How well do the study drugs reduce the risk of having a stroke * How much of REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)
Trial Details
NCT Number NCT07175428
Lead Sponsor Regeneron Pharmaceuticals
Conditions Atrial Fibrillation (AF)
Enrollment 1,200 participants
Start Date 2025-10-20
Primary Completion 2027-02-09 (estimated)
Study Completion 2027-04-21 (estimated)
Updated on ClinicalTrials.gov 2026-09-28