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NCT07213778ClinicalTrials.gov

REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants

A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)

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En resumen

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim…

Fase 32000 participantes buscados36 centros4 países

Categorías

Hematología37%Musculoesquelético21%Cardiovascular21%Respiratorio21%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2025-10-09; recorded start 2025-11-24
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 251 other studies in this databaseCounted from the lead sponsor named in the record (Regeneron Pharmaceuticals)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 32 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 2,000 participants (target), run at 36 sites, across 4 countries.

How this score is built
  • Enrolment33/40

    2,000 participants (target)

  • Site count18/25

    32 sites

  • Country count7/15

    4 countries

  • Planned duration6/10

    Planned over about 20 months

  • Sponsor scale9/10

    Regeneron Pharmaceuticals has led 248 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery compared to acetylsalicylic acid. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Afecciones

  • Symptomatic Venous Thromboembolism (VTE)

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Key Inclusion Criteria: 1. Is undergoing a primary elective unilateral TKA 2. Is in good health based on laboratory safety testing as described in the protocol Key Exclusion Criteria: 1. Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation 2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency) 3. History of thromboembolic disease or thrombophilia 4. History of platelet dysfunction 5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción2000 participantes buscados

Patrocinador y colaboradores

  • Regeneron Pharmaceuticals Patrocinador

Grupos e intervenciones

  • REGN7508 and PlaceboEXPERIMENTAL
  • Placebo and ASAACTIVE_COMPARATOR

Intervenciones

  • Fármaco Acetylsalicylic Acid (ASA)

    Administered per the protocol

  • Fármaco Placebo

    Administered per the protocol

  • Fármaco REGN7508

    Administered per the protocol

Variables de resultado

  1. Variable de resultado principal

    Incidence of the composite endpoint of symptomatic VTE and all-cause death

    Plazo Through day 30 visit

  2. Variable de resultado secundaria

    Incidence of all-cause death

    Plazo Through day 30 visit

  3. Variable de resultado secundaria

    Time to first event of the confirmed symptomatic DVT

    Plazo Through day 30 visit

  4. Variable de resultado secundaria

    Time to first event of the confirmed PE

    Plazo Through day 30 visit

  5. Variable de resultado secundaria

    Time to the all-cause death

    Plazo Through day 30 visit

  6. Variable de resultado secundaria

    Incidence of the composite endpoint of major bleeding and Clinically Relevant Non-Major (CRNM) bleeding

    Plazo Through day 30 visit

  7. Variable de resultado secundaria

    Incidence of minor bleeding

    Plazo Through day 30 visit

  8. Variable de resultado secundaria

    Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Plazo Through day 90 visit

  9. Variable de resultado secundaria

    Severity of TEAEs

    Plazo Through day 90 visit

  10. Variable de resultado secundaria

    Incidence of Anti-drug Antibody (ADA) to REGN7508

    Plazo Through day 90 visit

  11. Variable de resultado secundaria

    Magnitude of ADA to REGN7508

    Plazo Through day 90 visit

  12. Variable de resultado secundaria

    Concentrations of REGN7508

    Plazo Through day 90 visit

  13. Variable de resultado secundaria

    Time to first event of the composite endpoint of symptomatic VTE and all-cause death

    Plazo Through day 30 visit

  14. Variable de resultado secundaria

    Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)

    Plazo Through day 30 visit

  15. Variable de resultado secundaria

    Incidence of confirmed Pulmonary Embolism (PE)

    Plazo Through day 30 visit

Fechas

Fecha de inicio24 de noviembre de 2025 (real)
Finalización principal17 de mayo de 2027 (estimada)
Finalización16 de julio de 2027 (estimada)
Primera publicación9 de octubre de 2025 (real)
Última actualización14 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

34 centros están en reclutamiento

Greece

CentroCiudadEstado o regiónEstado
Henry Dunant Hospital CenterAthensAtticaEn reclutamiento

Malaysia

CentroCiudadEstado o regiónEstado
Hospital Pakar Universiti Sains MalaysiaKota BharuKelantanEn reclutamiento
Hospital Queen Elizabeth IIKota KinabaluSabahEn reclutamiento
Hospital Tengku Ampuan Afzan (HTTA)KuantanPahangEn reclutamiento
Sultan Abdul Halim HospitalSungai PetaniKedahEn reclutamiento

Moldova

CentroCiudadEstado o regiónEstado
PMSI Emergency Medicine InstituteChisinauEn reclutamiento

United States

CentroCiudadEstado o regiónEstado
Velocity Clinical Research, AnnapolisAnnapolisMarylandEn reclutamiento
Sinai Hospital of Baltimore, Inc.BaltimoreMarylandEn reclutamiento
Boston Medical CenterBostonMassachusettsEn reclutamiento
Tufts Medical CenterBostonMassachusettsEn reclutamiento
University of CincinnatiCincinnatiOhioEn reclutamiento
The Ohio State University Wexner Medical CenterColumbusOhioEn reclutamiento
Ohio Clinical TrialsColumbusOhioEn reclutamiento
South Florida Joint Replacement CenterDeerfield BeachFloridaEn reclutamiento
Duke University Health System (Duke Health), Duke University HospitalDurhamNorth CarolinaEn reclutamiento
HD Research - Memorial Hermann VillageHoustonTexasCompletado
NextStage Clinical Research, All American Orthopedics and Sports MedicineHoustonTexasEn reclutamiento
The Orthopaedic Research Foundation, Inc.IndianapolisIndianaEn reclutamiento
Horizon Clinical ResearchLa MesaCaliforniaEn reclutamiento
Sky Ridge Medical CenterLone TreeColoradoEn reclutamiento
Medical Research of Westchester - MPLUS Research NetworkMiamiFloridaEn reclutamiento
University of PittsburghPittsburghPennsylvaniaEn reclutamiento
Eximia Equihealth Research-Raleigh. LLCRaleighNorth CarolinaEn reclutamiento
The Vein and Vascular Center at Raleigh RadiologyRaleighNorth CarolinaEn reclutamiento
Eisenhower Medical CenterRancho MirageCaliforniaEn reclutamiento
Carilion ClinicRoanokeVirginiaEn reclutamiento
University of Rochester Medical CenterRochesterNew YorkEn reclutamiento
Endeavor Clinical TrialsSan AntonioTexasRetirado
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)San AntonioTexasEn reclutamiento
Endeavor HealthSkokieIllinoisEn reclutamiento
Larkin Community Hospital South MiamiSouth MiamiFloridaEn reclutamiento
Spokane Joint Replacement CenterSpokaneWashingtonEn reclutamiento
Phoenix Clinical ResearchTamaracFloridaEn reclutamiento
Holy Name Medical CenterTeaneckNew JerseyEn reclutamiento
NextStage Clinical Research, St. Francis Medical ParkWichitaKansasEn reclutamiento
Coastal Vascular Institute, PAWilmingtonNorth CarolinaEn reclutamiento

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 14 de septiembre de 2026

    Centro añadido

    2 sites added (36 total)

    3436

  2. 19 de agosto de 2026

    Centro añadido

    2 sites added (34 total)

    3234

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07213778