Trial studying safety and effects 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?
This is an investigational medicine being studied to help prevent blood clots 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 checks if two new drugs, REGN7508 and REGN9933, are safe and work well to stop blood clots. It also compares their bleeding risks to a common medicine called apixaban.
- Who it's for
- Adults who have atrial fibrillation (an irregular heartbeat) and are already taking blood-thinning medicine.
- What's involved
- Participants will take one of the new study drugs or apixaban. They will have regular check-ups and blood tests to monitor safety and how the drug works in the body.
- Time commitment
- The source text does not specify the total duration or the exact number of visits required.
- 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...
- 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 Normalization 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 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...
The study team makes the final eligibility decision.
Where it is enrolling
- 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
- Redding, 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
+ 56 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 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 70 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.