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Tests treatment safety and results for Atrial Fibrillation (AF)
Official title Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
ClinicalTrials.gov ID: NCT07175428
What this study is testing
What is REGN7508?
REGN7508 is an investigational medicine, being studied as a potential treatment for atrial fibrillation (af).
Also referred to as cenvacibart.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation...
- Meets one of the following:
- CHA2DS2-VA [C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or...
- CHA2DS2-VA score ≥3 or
- CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol
You likely can't join if
- Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
- Has known moderate-to-severe mitral stenosis
- Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described...
- Had an ischemic stroke within 2 days prior to randomization
- Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m\^2 within 30 days prior to randomization or on dialysis or expected to be started...
- Has a history of central nervous system bleeding within 30 days prior to randomization Note: Other protocol-defined Inclusion/ Exclusion criteria...
See the full eligibility criteria
- Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol
- Meets one of the following:
- CHA2DS2-VA [C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years] score ≥2...
- CHA2DS2-VA score ≥3 or
- CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol
- Must have an International Normalization Ratio (INR) \<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA) Key
- Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
- Has known moderate-to-severe mitral stenosis
- Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol
- Had an ischemic stroke within 2 days prior to randomization
- Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m\^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol
- Has a history of central nervous system bleeding within 30 days prior to randomization Note: Other protocol-defined Inclusion/ Exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Fairhope, Alabama, United States
- Covina, California, United States
- Encinitas, California, United States
- Fremont, California, United States
- Huntington Beach, California, United States
- Pasadena, California, United States
- Pomona, California, United States
- Santa Rosa, California, United States
- Ventura, California, United States
- West Hills, California, United States
- Cutler Bay, Florida, United States
- Medley, Florida, United States
- Miami Lakes, Florida, United States
- Sarasota, Florida, United States
- Winter Park, Florida, United States
- Atlanta, Georgia, United States
- Johns Creek, Georgia, United States
- Indianapolis, Indiana, United States
- Merrillville, Indiana, United States
+ 35 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Fairhope, Alabama, United States; Covina, California, United States; Encinitas, California, United States; Fremont, California, United States; Huntington Beach, California, United States and 49 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.