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)

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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…

שלב 3דרושים 2,000 משתתפים36 אתרים4 מדינות

קטגוריות

המטולוגיה37%שרירים ושלד21%לב וכלי דם21%מערכת הנשימה21%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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)

מצבים רפואיים

  • Symptomatic Venous Thromboembolism (VTE)

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהQUADRUPLE (4)
גיוסדרושים 2,000 משתתפים

נותן חסות ושותפים

  • Regeneron Pharmaceuticals נותן חסות

זרועות והתערבויות

  • REGN7508 and PlaceboEXPERIMENTAL
  • Placebo and ASAACTIVE_COMPARATOR

התערבויות

  • תרופה Acetylsalicylic Acid (ASA)

    Administered per the protocol

  • תרופה Placebo

    Administered per the protocol

  • תרופה REGN7508

    Administered per the protocol

מדדי תוצאה

  1. מדד תוצאה ראשוני

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

    מסגרת זמן Through day 30 visit

  2. מדד תוצאה משני

    Incidence of all-cause death

    מסגרת זמן Through day 30 visit

  3. מדד תוצאה משני

    Time to first event of the confirmed symptomatic DVT

    מסגרת זמן Through day 30 visit

  4. מדד תוצאה משני

    Time to first event of the confirmed PE

    מסגרת זמן Through day 30 visit

  5. מדד תוצאה משני

    Time to the all-cause death

    מסגרת זמן Through day 30 visit

  6. מדד תוצאה משני

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

    מסגרת זמן Through day 30 visit

  7. מדד תוצאה משני

    Incidence of minor bleeding

    מסגרת זמן Through day 30 visit

  8. מדד תוצאה משני

    Incidence of Treatment-Emergent Adverse Events (TEAEs)

    מסגרת זמן Through day 90 visit

  9. מדד תוצאה משני

    Severity of TEAEs

    מסגרת זמן Through day 90 visit

  10. מדד תוצאה משני

    Incidence of Anti-drug Antibody (ADA) to REGN7508

    מסגרת זמן Through day 90 visit

  11. מדד תוצאה משני

    Magnitude of ADA to REGN7508

    מסגרת זמן Through day 90 visit

  12. מדד תוצאה משני

    Concentrations of REGN7508

    מסגרת זמן Through day 90 visit

  13. מדד תוצאה משני

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

    מסגרת זמן Through day 30 visit

  14. מדד תוצאה משני

    Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)

    מסגרת זמן Through day 30 visit

  15. מדד תוצאה משני

    Incidence of confirmed Pulmonary Embolism (PE)

    מסגרת זמן Through day 30 visit

תאריכים

תאריך התחלה24 בנובמבר 2025 (בפועל)
סיום ראשוני17 במאי 2027 (משוער)
סיום16 ביולי 2027 (משוער)
פורסם לראשונה9 באוקטובר 2025 (בפועל)
עודכן לאחרונה14 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהספטמבר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

34 אתרים מגייסים

Greece

מתקןעירמדינה או אזורמצב
Henry Dunant Hospital CenterAthensAtticaמגייס

Malaysia

מתקןעירמדינה או אזורמצב
Hospital Pakar Universiti Sains MalaysiaKota BharuKelantanמגייס
Hospital Queen Elizabeth IIKota KinabaluSabahמגייס
Hospital Tengku Ampuan Afzan (HTTA)KuantanPahangמגייס
Sultan Abdul Halim HospitalSungai PetaniKedahמגייס

Moldova

מתקןעירמדינה או אזורמצב
PMSI Emergency Medicine InstituteChisinauמגייס

United States

מתקןעירמדינה או אזורמצב
Velocity Clinical Research, AnnapolisAnnapolisMarylandמגייס
Sinai Hospital of Baltimore, Inc.BaltimoreMarylandמגייס
Boston Medical CenterBostonMassachusettsמגייס
Tufts Medical CenterBostonMassachusettsמגייס
University of CincinnatiCincinnatiOhioמגייס
The Ohio State University Wexner Medical CenterColumbusOhioמגייס
Ohio Clinical TrialsColumbusOhioמגייס
South Florida Joint Replacement CenterDeerfield BeachFloridaמגייס
Duke University Health System (Duke Health), Duke University HospitalDurhamNorth Carolinaמגייס
HD Research - Memorial Hermann VillageHoustonTexasהושלם
NextStage Clinical Research, All American Orthopedics and Sports MedicineHoustonTexasמגייס
The Orthopaedic Research Foundation, Inc.IndianapolisIndianaמגייס
Horizon Clinical ResearchLa MesaCaliforniaמגייס
Sky Ridge Medical CenterLone TreeColoradoמגייס
Medical Research of Westchester - MPLUS Research NetworkMiamiFloridaמגייס
University of PittsburghPittsburghPennsylvaniaמגייס
Eximia Equihealth Research-Raleigh. LLCRaleighNorth Carolinaמגייס
The Vein and Vascular Center at Raleigh RadiologyRaleighNorth Carolinaמגייס
Eisenhower Medical CenterRancho MirageCaliforniaמגייס
Carilion ClinicRoanokeVirginiaמגייס
University of Rochester Medical CenterRochesterNew Yorkמגייס
Endeavor Clinical TrialsSan AntonioTexasבוטל
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)San AntonioTexasמגייס
Endeavor HealthSkokieIllinoisמגייס
Larkin Community Hospital South MiamiSouth MiamiFloridaמגייס
Spokane Joint Replacement CenterSpokaneWashingtonמגייס
Phoenix Clinical ResearchTamaracFloridaמגייס
Holy Name Medical CenterTeaneckNew Jerseyמגייס
NextStage Clinical Research, St. Francis Medical ParkWichitaKansasמגייס
Coastal Vascular Institute, PAWilmingtonNorth Carolinaמגייס

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 14 בספטמבר 2026

    אתר נוסף

    2 sites added (36 total)

    3436

  2. 19 באוגוסט 2026

    אתר נוסף

    2 sites added (34 total)

    3234

מרשם: ClinicalTrials.gov · NCT########

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