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Prevention study for Atrial Fibrillation (AF)
Official title Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable
ClinicalTrials.gov ID: NCT07430956
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 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- At moderate to high risk for stroke defined as:
- 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 of 3 AND at least 1 enrichment criteria as described in the protocol
- Shared decision making between the participant and provider determining that the bleeding risk of Oral Anticoagulant (OAC) therapy outweighs the...
You likely can't join if
- Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
- Had an ischemic stroke within 2 days prior to randomization
- Has persistent, uncontrolled hypertension (per investigator's discretion)
- Has a history of Central Nervous System (CNS) bleeding within 30 days prior to randomization
- Has a life expectancy less than 12 months
- Has participated in a prior Factor XI (FXI) inhibitor study 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
- Fremont, California, United States
- Huntington Beach, California, United States
- Pasadena, California, United States
- Ventura, California, United States
- West Hills, California, United States
- Medley, Florida, United States
- Pensacola, Florida, United States
- Winter Park, Florida, United States
- Johns Creek, Georgia, United States
- West Monroe, Louisiana, United States
- Farmington Hills, Michigan, United States
- Flint, Michigan, United States
- Marion, Ohio, United States
- Anderson, South Carolina, United States
- Amarillo, Texas, United States
- Dallas, Texas, United States
- McKinney, Texas, United States
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; Fremont, California, United States; Huntington Beach, California, United States; Pasadena, California, United States; Ventura, California, United States; West Hills, California, United States and 12 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.