Prevention trial for Atrial Fibrillation (AF)
Official title Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
ClinicalTrials.gov ID: NCT07626411
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 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.
- Phase 3: a large, late-stage study
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 considered 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 Systemic...
- 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 a successful ablation therapy without documented recurrent AF or a participant after Left Atrial Appendage (LAA) occlusion/exclusion or plan...
- Had an ischemic stroke within 2 days prior to randomization
- Has persistent, uncontrolled hypertension (per investigator's discretion)
- 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...
See the full eligibility criteria
- 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
- 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 Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years] score...
- 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 Normalized 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 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...
- Had an ischemic stroke within 2 days prior to randomization
- Has persistent, uncontrolled hypertension (per investigator's discretion)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Alexander City, Alabama, United States
- Dothan, Alabama, United States
- Glendale, Arizona, United States
- Fremont, California, United States
- La Jolla, California, United States
- Newport Beach, California, United States
- Northridge, California, United States
- Pasadena, California, United States
- Ventura, California, United States
- West Hills, California, United States
- Cutler Bay, Florida, United States
- Pensacola, Florida, United States
- Sarasota, Florida, United States
- Atlanta, Georgia, United States
- Johns Creek, Georgia, United States
- Munster, Indiana, United States
- West Monroe, Louisiana, United States
- Ft. Washington, Maryland, United States
- Bloomfield Hills, Michigan, United States
- Farmington Hills, Michigan, United States
+ 11 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 Alexander City, Alabama, United States; Dothan, Alabama, United States; Glendale, Arizona, United States; Fremont, California, United States; La Jolla, California, United States; Newport Beach, California, United States and 25 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.