REGN7508 and REGN9933 for Atrial Fibrillation
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable
Recruiting
Phase 3
Interventional Study
Atrial Fibrillation (AF)
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.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 2,628 (estimated)
- Sponsor
- Regeneron Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with atrial fibrillation who are unable or choose not to take blood thinners. Participants will take one of two study drugs to see how well they help prevent strokes and blood clots.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with atrial fibrillation
- I am at moderate to high risk for stroke
- My doctor and I decided that blood thinners are not suitable for me
You may not be able to join if
- I have a mechanical heart valve
- I had a stroke in the last 2 days
- I have uncontrolled high blood pressure
- I have had bleeding in my brain in the last 30 days
- My life expectancy is less than 12 months
- I have participated in a previous study of Factor XI inhibitors
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 a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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…
Trial Locations
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Eligibility Criteria
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;…
Contacts