xMedica

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)

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati36 centri4 paesi

Categorie

Ematologia37%Apparato muscoloscheletrico21%Cardiovascolare21%Apparato respiratorio21%

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

Ti interessa questo studio?

Accedi oppure crea un account per registrare il tuo interesse e seguire questo studio.

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.

Sintesi

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)

Patologie

  • Symptomatic Venous Thromboembolism (VTE)

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoQUADRUPLE (4)
Arruolamento2000 partecipanti ricercati

Sponsor e collaboratori

  • Regeneron Pharmaceuticals Sponsor

Bracci e interventi

  • REGN7508 and PlaceboEXPERIMENTAL
  • Placebo and ASAACTIVE_COMPARATOR

Interventi

  • Farmaco Acetylsalicylic Acid (ASA)

    Administered per the protocol

  • Farmaco Placebo

    Administered per the protocol

  • Farmaco REGN7508

    Administered per the protocol

Esiti misurati

  1. Esito primario

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

    Orizzonte temporale Through day 30 visit

  2. Esito secondario

    Incidence of all-cause death

    Orizzonte temporale Through day 30 visit

  3. Esito secondario

    Time to first event of the confirmed symptomatic DVT

    Orizzonte temporale Through day 30 visit

  4. Esito secondario

    Time to first event of the confirmed PE

    Orizzonte temporale Through day 30 visit

  5. Esito secondario

    Time to the all-cause death

    Orizzonte temporale Through day 30 visit

  6. Esito secondario

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

    Orizzonte temporale Through day 30 visit

  7. Esito secondario

    Incidence of minor bleeding

    Orizzonte temporale Through day 30 visit

  8. Esito secondario

    Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Orizzonte temporale Through day 90 visit

  9. Esito secondario

    Severity of TEAEs

    Orizzonte temporale Through day 90 visit

  10. Esito secondario

    Incidence of Anti-drug Antibody (ADA) to REGN7508

    Orizzonte temporale Through day 90 visit

  11. Esito secondario

    Magnitude of ADA to REGN7508

    Orizzonte temporale Through day 90 visit

  12. Esito secondario

    Concentrations of REGN7508

    Orizzonte temporale Through day 90 visit

  13. Esito secondario

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

    Orizzonte temporale Through day 30 visit

  14. Esito secondario

    Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)

    Orizzonte temporale Through day 30 visit

  15. Esito secondario

    Incidence of confirmed Pulmonary Embolism (PE)

    Orizzonte temporale Through day 30 visit

Date

Data di inizio24 novembre 2025 (effettiva)
Conclusione primaria17 maggio 2027 (stimata)
Conclusione16 luglio 2027 (stimata)
Prima pubblicazione9 ottobre 2025 (effettiva)
Ultimo aggiornamento14 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

34 centri stanno reclutando

Greece

StrutturaCittàStato o regioneStato
Henry Dunant Hospital CenterAthensAtticaIn reclutamento

Malaysia

StrutturaCittàStato o regioneStato
Hospital Pakar Universiti Sains MalaysiaKota BharuKelantanIn reclutamento
Hospital Queen Elizabeth IIKota KinabaluSabahIn reclutamento
Hospital Tengku Ampuan Afzan (HTTA)KuantanPahangIn reclutamento
Sultan Abdul Halim HospitalSungai PetaniKedahIn reclutamento

Moldova

StrutturaCittàStato o regioneStato
PMSI Emergency Medicine InstituteChisinauIn reclutamento

United States

StrutturaCittàStato o regioneStato
Velocity Clinical Research, AnnapolisAnnapolisMarylandIn reclutamento
Sinai Hospital of Baltimore, Inc.BaltimoreMarylandIn reclutamento
Boston Medical CenterBostonMassachusettsIn reclutamento
Tufts Medical CenterBostonMassachusettsIn reclutamento
University of CincinnatiCincinnatiOhioIn reclutamento
The Ohio State University Wexner Medical CenterColumbusOhioIn reclutamento
Ohio Clinical TrialsColumbusOhioIn reclutamento
South Florida Joint Replacement CenterDeerfield BeachFloridaIn reclutamento
Duke University Health System (Duke Health), Duke University HospitalDurhamNorth CarolinaIn reclutamento
HD Research - Memorial Hermann VillageHoustonTexasCompletato
NextStage Clinical Research, All American Orthopedics and Sports MedicineHoustonTexasIn reclutamento
The Orthopaedic Research Foundation, Inc.IndianapolisIndianaIn reclutamento
Horizon Clinical ResearchLa MesaCaliforniaIn reclutamento
Sky Ridge Medical CenterLone TreeColoradoIn reclutamento
Medical Research of Westchester - MPLUS Research NetworkMiamiFloridaIn reclutamento
University of PittsburghPittsburghPennsylvaniaIn reclutamento
Eximia Equihealth Research-Raleigh. LLCRaleighNorth CarolinaIn reclutamento
The Vein and Vascular Center at Raleigh RadiologyRaleighNorth CarolinaIn reclutamento
Eisenhower Medical CenterRancho MirageCaliforniaIn reclutamento
Carilion ClinicRoanokeVirginiaIn reclutamento
University of Rochester Medical CenterRochesterNew YorkIn reclutamento
Endeavor Clinical TrialsSan AntonioTexasRitirato
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)San AntonioTexasIn reclutamento
Endeavor HealthSkokieIllinoisIn reclutamento
Larkin Community Hospital South MiamiSouth MiamiFloridaIn reclutamento
Spokane Joint Replacement CenterSpokaneWashingtonIn reclutamento
Phoenix Clinical ResearchTamaracFloridaIn reclutamento
Holy Name Medical CenterTeaneckNew JerseyIn reclutamento
NextStage Clinical Research, St. Francis Medical ParkWichitaKansasIn reclutamento
Coastal Vascular Institute, PAWilmingtonNorth CarolinaIn reclutamento

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 14 settembre 2026

    Centro aggiunto

    2 sites added (36 total)

    3436

  2. 19 agosto 2026

    Centro aggiunto

    2 sites added (34 total)

    3234

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

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