Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07430956 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable

Study acronym: ROXI-INCLINE
StatusRecruiting
PhasePhase 3
Started2026-04-03
View on ClinicalTrials.gov ↗

Amendment history

2026-09-18
minor
Trial sites expanded: 18 → 35 locations
2026-06-22
minor
Study Status, Contacts/Locations v3
Trial sites expanded: 13 → 18 locations
2026-05-26
minor
Study Status, Arms and Interventions, Contacts/Locations v2
Trial sites expanded: 5 → 13 locations
2026-04-23
notable
Study Status, Contacts/Locations v1
Recruitment opened
Trial sites expanded: 0 → 5 locations
Start dateestimated 2026-03-18→confirmed 2026-04-03
2026-02-18
minor
Original filing
148 trials monitored
See 16 trials at risk
This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in one spot, which can lead to the formation of blood clots. 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 effective and safe REGN7508 and REGN9933, individually, are in preventing ischemic stroke or systemic embolism in people with atrial fibrillation who cannot or may choose to not take blood thinners. The study is looking at several other research questions, including: * What side effects may happen from taking REGN7508 or REGN9933 * How well does REGN7508 or REGN9933 lower the risk of having an ischemic stroke and/or systemic embolism compared to the placebo * How well does REGN7508 or REGN9933 lower the risk of having a major health problem affecting heart and blood circulation compared to placebo * How well does REGN7508 or REGN9933 lower the risk of death compared to placebo * How much REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the study drugs less effective or could lead to side effects)
Trial Details
NCT Number NCT07430956
Lead Sponsor Regeneron Pharmaceuticals
Conditions Atrial Fibrillation (AF)
Enrollment 2,628 participants
Start Date 2026-04-03
Primary Completion 2029-03-28 (estimated)
Study Completion 2029-06-26 (estimated)
Updated on ClinicalTrials.gov 2026-09-17