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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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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…

Phase 32.000 Teilnehmende gesucht36 Studienzentren4 Länder

Kategorien

Hämatologie37%Bewegungsapparat21%Herz-Kreislauf21%Atemwege21%

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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.

Zusammenfassung

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)

Erkrankungen

  • Symptomatic Venous Thromboembolism (VTE)

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungQUADRUPLE (4)
Teilnahme2.000 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Regeneron Pharmaceuticals Sponsor

Studienarme und Interventionen

  • REGN7508 and PlaceboEXPERIMENTAL
  • Placebo and ASAACTIVE_COMPARATOR

Interventionen

  • Arzneimittel Acetylsalicylic Acid (ASA)

    Administered per the protocol

  • Arzneimittel Placebo

    Administered per the protocol

  • Arzneimittel REGN7508

    Administered per the protocol

Endpunkte

  1. Primärer Endpunkt

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

    Zeitrahmen Through day 30 visit

  2. Sekundärer Endpunkt

    Incidence of all-cause death

    Zeitrahmen Through day 30 visit

  3. Sekundärer Endpunkt

    Time to first event of the confirmed symptomatic DVT

    Zeitrahmen Through day 30 visit

  4. Sekundärer Endpunkt

    Time to first event of the confirmed PE

    Zeitrahmen Through day 30 visit

  5. Sekundärer Endpunkt

    Time to the all-cause death

    Zeitrahmen Through day 30 visit

  6. Sekundärer Endpunkt

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

    Zeitrahmen Through day 30 visit

  7. Sekundärer Endpunkt

    Incidence of minor bleeding

    Zeitrahmen Through day 30 visit

  8. Sekundärer Endpunkt

    Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Zeitrahmen Through day 90 visit

  9. Sekundärer Endpunkt

    Severity of TEAEs

    Zeitrahmen Through day 90 visit

  10. Sekundärer Endpunkt

    Incidence of Anti-drug Antibody (ADA) to REGN7508

    Zeitrahmen Through day 90 visit

  11. Sekundärer Endpunkt

    Magnitude of ADA to REGN7508

    Zeitrahmen Through day 90 visit

  12. Sekundärer Endpunkt

    Concentrations of REGN7508

    Zeitrahmen Through day 90 visit

  13. Sekundärer Endpunkt

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

    Zeitrahmen Through day 30 visit

  14. Sekundärer Endpunkt

    Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)

    Zeitrahmen Through day 30 visit

  15. Sekundärer Endpunkt

    Incidence of confirmed Pulmonary Embolism (PE)

    Zeitrahmen Through day 30 visit

Daten

Startdatum24. November 2025 (tatsächlich)
Primärer Abschluss17. Mai 2027 (geschätzt)
Abschluss16. Juli 2027 (geschätzt)
Erstveröffentlichung9. Oktober 2025 (tatsächlich)
Zuletzt aktualisiert14. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtSeptember 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

34 Studienzentren rekrutieren

Greece

EinrichtungStadtBundesland oder RegionStatus
Henry Dunant Hospital CenterAthensAtticaRekrutiert

Malaysia

EinrichtungStadtBundesland oder RegionStatus
Hospital Pakar Universiti Sains MalaysiaKota BharuKelantanRekrutiert
Hospital Queen Elizabeth IIKota KinabaluSabahRekrutiert
Hospital Tengku Ampuan Afzan (HTTA)KuantanPahangRekrutiert
Sultan Abdul Halim HospitalSungai PetaniKedahRekrutiert

Moldova

EinrichtungStadtBundesland oder RegionStatus
PMSI Emergency Medicine InstituteChisinauRekrutiert

United States

EinrichtungStadtBundesland oder RegionStatus
Velocity Clinical Research, AnnapolisAnnapolisMarylandRekrutiert
Sinai Hospital of Baltimore, Inc.BaltimoreMarylandRekrutiert
Boston Medical CenterBostonMassachusettsRekrutiert
Tufts Medical CenterBostonMassachusettsRekrutiert
University of CincinnatiCincinnatiOhioRekrutiert
The Ohio State University Wexner Medical CenterColumbusOhioRekrutiert
Ohio Clinical TrialsColumbusOhioRekrutiert
South Florida Joint Replacement CenterDeerfield BeachFloridaRekrutiert
Duke University Health System (Duke Health), Duke University HospitalDurhamNorth CarolinaRekrutiert
HD Research - Memorial Hermann VillageHoustonTexasAbgeschlossen
NextStage Clinical Research, All American Orthopedics and Sports MedicineHoustonTexasRekrutiert
The Orthopaedic Research Foundation, Inc.IndianapolisIndianaRekrutiert
Horizon Clinical ResearchLa MesaCaliforniaRekrutiert
Sky Ridge Medical CenterLone TreeColoradoRekrutiert
Medical Research of Westchester - MPLUS Research NetworkMiamiFloridaRekrutiert
University of PittsburghPittsburghPennsylvaniaRekrutiert
Eximia Equihealth Research-Raleigh. LLCRaleighNorth CarolinaRekrutiert
The Vein and Vascular Center at Raleigh RadiologyRaleighNorth CarolinaRekrutiert
Eisenhower Medical CenterRancho MirageCaliforniaRekrutiert
Carilion ClinicRoanokeVirginiaRekrutiert
University of Rochester Medical CenterRochesterNew YorkRekrutiert
Endeavor Clinical TrialsSan AntonioTexasZurückgezogen
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)San AntonioTexasRekrutiert
Endeavor HealthSkokieIllinoisRekrutiert
Larkin Community Hospital South MiamiSouth MiamiFloridaRekrutiert
Spokane Joint Replacement CenterSpokaneWashingtonRekrutiert
Phoenix Clinical ResearchTamaracFloridaRekrutiert
Holy Name Medical CenterTeaneckNew JerseyRekrutiert
NextStage Clinical Research, St. Francis Medical ParkWichitaKansasRekrutiert
Coastal Vascular Institute, PAWilmingtonNorth CarolinaRekrutiert

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 14. September 2026

    Studienzentrum hinzugefügt

    2 sites added (36 total)

    3436

  2. 19. August 2026

    Studienzentrum hinzugefügt

    2 sites added (34 total)

    3234

Register: ClinicalTrials.gov · NCT########

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