Atrial Fibrillation study: REGN7508 vs Apixaban
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?
an investigational drug being studied as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation
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 testing whether REGN7508 (an experimental drug) is safe and works to prevent stroke or blood clots compared with apixaban in people with atrial fibrillation.
- Who it's for
- You may be able to join if you are an adult with atrial fibrillation.
- What's involved
- You will take either REGN7508 or apixaban by mouth. You will have regular doctor visits and blood tests to check safety and side effects.
- 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...
- CHA2DS2-VA [C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus
- 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
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...
The study team makes the final eligibility decision.
Where it is enrolling
- Alexander City, Alabama, United States
- Dothan, Alabama, United States
- Fairhope, Alabama, United States
- Glendale, Arizona, United States
- Scottsdale, Arizona, United States
- Little Rock, Arkansas, United States
- Covina, California, United States
- Fremont, California, United States
- Huntington Beach, California, United States
- Inglewood, California, United States
- La Jolla, California, United States
- Newport Beach, California, United States
- Northridge, California, United States
- Pasadena, California, United States
- Santa Maria, California, United States
- Ventura, California, United States
- West Hills, California, United States
- Boca Raton, Florida, United States
- Cutler Bay, Florida, United States
- Inverness, Florida, United States
+ 43 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, but 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?
This study is enrolling now at Alexander City, Alabama, United States; Dothan, Alabama, United States; Fairhope, Alabama, United States; Glendale, Arizona, United States; Scottsdale, Arizona, United States; Little Rock, Arkansas, United States and 57 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.