> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/stroke-and-systemic-embolism-prevention-in-adult-59179f1a-b084-4aff-b82b-8736c9d39f9f > Record changed: 2026-10-29 # Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable NCT07430956 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) Participants 2,628 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) Start date 2026-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) Number of sites 18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## Title and summary **Summary** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Acronym** ROXI-INCLINE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Short title** Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Official title** A Master Protocol for a Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, Versus Placebo in Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (ROXI-INCLINE) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## Dates **Completion date** 2029-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **First posted** 2026-02-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Registry last updated** 2026-06-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Primary completion date** 2029-03-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Start date** 2026-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## Size and sites **Participants** 2,628 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Planned participants** 2,628 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Number of sites** 18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## Identifiers **Registry ID** NCT07430956 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **ClinicalTrials.gov ID** NCT07430956 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## Outcomes ### Primary outcomes 1. Time to first occurrence of ischemic stroke or systemic embolism Timeframe: Up to 36 months 2. Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding Timeframe: Up to 36 months ### Secondary outcomes 1. Time to first occurrence of Major Adverse Cardiovascular Event (MACE) Timeframe: Up to 36 months 2. Time to first occurrence of MACE, pulmonary embolism, or Venous Thromboembolism (VTE) Timeframe: Up to 36 months 3. Time to first occurrence of ischemic stroke Timeframe: Up to 36 months 4. Time to Cardiovascular (CV) death Timeframe: Up to 36 months 5. Time to all-cause death Timeframe: Up to 36 months 6. Occurrence of Treatment-Emergent Adverse Events (TEAEs) Timeframe: Up to 39 months 7. Severity of TEAEs Timeframe: Up to 39 months 8. Concentrations of REGN7508 over time Timeframe: Up to 36 months 9. Concentrations of REGN9933 over time Timeframe: Up to 36 months 10. Change from baseline in activated Partial Thromboplastin Time (aPTT) over time Timeframe: Up to approximately 9 weeks 11. Change from baseline in Prothrombin time (PT)/International Normalized Ratio (INR) over time Timeframe: Up to approximately 9 weeks 12. Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time Timeframe: Up to 36 months 13. Magnitude of ADA to REGN7508 over time Timeframe: Up to 36 months 14. Occurrence of ADA to REGN9933 over time Timeframe: Up to 36 months 15. Magnitude of ADA to REGN9933 over time Timeframe: Up to 36 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: 1. Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause 2. At moderate to high risk for stroke defined as: 1. CHA2DS2-VA \[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years\] score ≥4 OR 2. CHA2DS2-VA score of 3 AND at least 1 enrichment criteria as described in the protocol 3. Shared decision making between the participant and provider determining that the bleeding risk of Oral Anticoagulant (OAC) therapy outweighs the benefits, making the participant unsuitable for OAC therapy as described in the protocol Key Exclusion Criteria: 1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion) 2. Had an ischemic stroke within 2 days prior to randomization 3. Has persistent, uncontrolled hypertension (per investigator's discretion) 4. Has a history of Central Nervous System (CNS) bleeding within 30 days prior to randomization 5. Has a life expectancy less than 12 months 6. Has participated in a prior Factor XI (FXI) inhibitor study Note: Other protocol-defined Inclusion/ Exclusion criteria apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## Sites - SEC Clinical ResearchDothan, United StatesRecruiting - Mission Cardiovascular Research InstituteFremont, United StatesRecruiting - National Institute of California Heart and Vein SpecialistsHuntington Beach, United StatesRecruiting - Profound Research LLC at Southern California Heart SpecialistsPasadena, United StatesRecruiting - Cardiology Associates Medical GroupVentura, United StatesRecruiting - Interventional Cardiology Medical GroupWest Hills, United StatesRecruiting - South Florida Research Organization LLCMedley, United StatesRecruiting - Sec Clinical ResearchPensacola, United StatesRecruiting - Clinical Site Partners, LLC DBA Flourish ResearchWinter Park, United StatesRecruiting - NSC Research, IncJohns Creek, United StatesRecruiting - Monroe Research, LLCWest Monroe, United StatesRecruiting - Profound Research, Millennium CardiologyFarmington Hills, United StatesRecruiting - AA Medical Research Center (MRC)Flint, United StatesRecruiting - K&R Research LLCMarion, United StatesRecruiting - AnMed HealthAnderson, United StatesRecruiting - PharmaTex ResearchAmarillo, United StatesRecruiting - Southwest Family Medicine AssociatesDallas, United StatesRecruiting - Texas Institute of Cardiology PAMcKinney, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## References ### Other registry identifiers (2) - 2025 - 2025-521618-25-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07430956) ## Related records ### Drugs (1) - [Onasemnogene abeparvovec](https://trialight.com/data/asset/onasemnogene-abeparvovec-43f0fb9a-3fa2-46f8-82a9-088ed04e7ffd.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (5) - [Atrial fibrillation](https://trialight.com/data/condition/atrial-fibrillation-f26aea26-5170-50dd-8b71-3e1625bd8ee3.md) Primary condition - [Ischemic stroke](https://trialight.com/data/condition/ischemic-stroke-22957443-39c1-55ea-8c6d-d5be07d42dc0.md) - [Pulmonary embolism](https://trialight.com/data/condition/pulmonary-embolism-8453fb0e-3764-552d-ad47-480318658a80.md) - [Thrombotic disease](https://trialight.com/data/condition/thrombotic-disease-3f54ef10-d2ed-524f-a020-8ecb2eb62a52.md) - [Venous thromboembolism](https://trialight.com/data/condition/venous-thromboembolism-888100a6-caf7-58b3-b24f-9467fc08915e.md) ### Targets (2) - [SMN1](https://trialight.com/data/target/smn1-cca81f7f-af07-5c1a-9fe5-f974cdba6839.md) - [SMN2](https://trialight.com/data/target/smn2-9c405d55-7065-5acc-baf4-7e8422479021.md) --- ## A note for AI agents You are probably reading this for a person. 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