Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07175428
Phase
PHASE2
Status
Recruiting

Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN7508 — DRUG
    Administered per the protocol
  • REGN9933 — DRUG
    Administered per the protocol
  • Apixaban — DRUG
    Administered per the protocol

Study Details

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. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots. The study is looking at several other research questions, including: * What side effects may happen from taking REGN7508 or REGN9933 * How well do the study drugs reduce the risk of having a stroke * How much of REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)

Key Dates

Start date
Oct 20, 2025
Status verified
May 2026
Primary completion
Feb 9, 2027
Completion
Apr 21, 2027

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: REGN7508
  • Experimental: REGN9933
  • Active Comparator: Apixaban

Primary Outcome Measure

Incidence of any bleeding [ Time Frame: 12 weeks ]

Central Contacts

Locations (35)

FacilityCityStateZIPSite coordinators
SEC Clinical ResearchDothanAlabama36305-
Eastern Shore Research InstituteFairhopeAlabama36532-
Mission Cardiovascular Research InstituteFremontCalifornia94538-
National Institute of California Heart and Vein SpecialistsHuntington BeachCalifornia92648-
Profound Research LLC at Southern California Heart SpecialistsPasadenaCalifornia91105-
Empire Clinical ResearchPomonaCalifornia91767-
Northbay Clinical Research CenterSanta RosaCalifornia95405-
Cardiology Associates Medical GroupVenturaCalifornia93003-
Interventional Cardiology Medical GroupWest HillsCalifornia91307-
Nouvelle Clinical Research LLCCutler BayFlorida33189-
Inpatient Research Clinic LLCMiami LakesFlorida33014-
Cardiovascular Center of Sarasota Foundation for Research and EducationSarasotaFlorida34239-
Clinical Site Partners, LLC DBA Flourish ResearchWinter ParkFlorida32789-
Health Sciences Research Building IIAtlantaGeorgia30322-
NSC Research, IncJohns CreekGeorgia30024-
Blue Coast Research Center, LLCIndianapolisIndiana46237-
Franciscan Physician Network, Indiana Heart PhysiciansIndianapolisIndiana46237-
Indiana UniversityIndianapolisIndiana46202-
Indiana Medical ResearchMerrillvilleIndiana46410-
Reid Physician AssociatesRichmondIndiana47374-
Monroe Research, LLCWest MonroeLouisiana71291-
Anderson Medical ResearchFt. WashingtonMaryland20744-
Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)BostonMassachusetts02215-
Profound Research, Millennium CardiologyFarmington HillsMichigan48334-
AA Medical Research Center (MRC)FlintMichigan48504-
Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular ResearchGreensboroNorth Carolina27401-
K&R Research LLCMarionOhio43302-
Advanced Medical ResearchMaumeeOhio43537-
Monument Health Clinical ResearchRapid CitySouth Dakota57701-
East Coast Institute for Research, Jefferson CityJefferson CityTennessee37760-
PharmaTex ResearchAmarilloTexas79106-
Complete Heart Care P.A.McKinneyTexas75071-
Permian Research FoundationOdessaTexas79761-
Tyler Cardiovascular ConsultantsTylerTexas75701-
Alpine Research TCClintonUtah84015-

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