No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
15,364 (estimated)
Sponsor
Regeneron Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with atrial fibrillation who need treatment to prevent strokes. Participants will receive either the study drug REGN7508 or another medication called apixaban.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with atrial fibrillation or flutter.
I need long-term anticoagulation treatment.
I have a CHA2DS2-VA score of 2 or higher.
I am not currently taking an oral anticoagulant.
I have an INR less than 2.5 if I am taking warfarin.
You may not be able to join if
I have a mechanical heart valve.
I have moderate to severe mitral stenosis.
I had an ischemic stroke in the past 2 days.
I have uncontrolled high blood pressure.
I have poor kidney function or am on dialysis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly.
The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with a…
This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly.
The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Trial Locations
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City
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Status
Eligibility Criteria
Key Inclusion Criteria:
1. Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol
2. Meets one of the following:
1. CHA2DS2-VA \[C: Congestive heart failure; H: H…
Key Inclusion Criteria:
1. Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol
2. Meets one of the following:
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 ≥2 and Oral Anticoagulant (OAC) naïve OR
2. CHA2DS2-VA score ≥3 OR
3. CHA2DS2-VA score of 2 AND at least 1 enrichment criteria as described in the protocol
3. Must have an International Normalized Ratio (INR) \<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)
Key Exclusion Criteria:
1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
2. Has known moderate-to-severe mitral stenosis
3. Has had a successful ablation therapy without documented recurrent AF or a participant after Left Atrial Appendage (LAA) occlusion/exclusion or plan for ablation or LAA occlusion/exclusion within the next 6 months starting from randomization
4. Had an ischemic stroke within 2 days prior to randomization
5. Has persistent, uncontrolled hypertension (per investigator's discretion)
6. Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m2 within 30 days prior to randomization or is on dialysis or expected to be started on dialysis within the next 6 months starting from randomization
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
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