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)

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 2,000 مشارك36 موقعاً4 دول

الفئات

أمراض الدم37%الجهاز العضلي الهيكلي21%القلب والأوعية الدموية21%الجهاز التنفسي21%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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)

الحالات

  • Symptomatic Venous Thromboembolism (VTE)

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 2,000 مشارك

الجهة الراعية والمتعاونون

  • Regeneron Pharmaceuticals الجهة الراعية

الأذرع والتدخلات

  • REGN7508 and PlaceboEXPERIMENTAL
  • Placebo and ASAACTIVE_COMPARATOR

التدخلات

  • دواء Acetylsalicylic Acid (ASA)

    Administered per the protocol

  • دواء Placebo

    Administered per the protocol

  • دواء REGN7508

    Administered per the protocol

مقاييس النتائج

  1. مقياس النتيجة الأولي

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

    الإطار الزمني Through day 30 visit

  2. مقياس النتيجة الثانوي

    Incidence of all-cause death

    الإطار الزمني Through day 30 visit

  3. مقياس النتيجة الثانوي

    Time to first event of the confirmed symptomatic DVT

    الإطار الزمني Through day 30 visit

  4. مقياس النتيجة الثانوي

    Time to first event of the confirmed PE

    الإطار الزمني Through day 30 visit

  5. مقياس النتيجة الثانوي

    Time to the all-cause death

    الإطار الزمني Through day 30 visit

  6. مقياس النتيجة الثانوي

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

    الإطار الزمني Through day 30 visit

  7. مقياس النتيجة الثانوي

    Incidence of minor bleeding

    الإطار الزمني Through day 30 visit

  8. مقياس النتيجة الثانوي

    Incidence of Treatment-Emergent Adverse Events (TEAEs)

    الإطار الزمني Through day 90 visit

  9. مقياس النتيجة الثانوي

    Severity of TEAEs

    الإطار الزمني Through day 90 visit

  10. مقياس النتيجة الثانوي

    Incidence of Anti-drug Antibody (ADA) to REGN7508

    الإطار الزمني Through day 90 visit

  11. مقياس النتيجة الثانوي

    Magnitude of ADA to REGN7508

    الإطار الزمني Through day 90 visit

  12. مقياس النتيجة الثانوي

    Concentrations of REGN7508

    الإطار الزمني Through day 90 visit

  13. مقياس النتيجة الثانوي

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

    الإطار الزمني Through day 30 visit

  14. مقياس النتيجة الثانوي

    Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)

    الإطار الزمني Through day 30 visit

  15. مقياس النتيجة الثانوي

    Incidence of confirmed Pulmonary Embolism (PE)

    الإطار الزمني Through day 30 visit

التواريخ

تاريخ البدء24 نوفمبر 2025 (فعلي)
الإتمام الأولي17 مايو 2027 (تقديري)
الإتمام16 يوليو 2027 (تقديري)
أول نشر9 أكتوبر 2025 (فعلي)
آخر تحديث14 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

34 موقعاً قيد التجنيد

Greece

المنشأةالمدينةالولاية أو المنطقةالحالة
Henry Dunant Hospital CenterAthensAtticaقيد التجنيد

Malaysia

المنشأةالمدينةالولاية أو المنطقةالحالة
Hospital Pakar Universiti Sains MalaysiaKota BharuKelantanقيد التجنيد
Hospital Queen Elizabeth IIKota KinabaluSabahقيد التجنيد
Hospital Tengku Ampuan Afzan (HTTA)KuantanPahangقيد التجنيد
Sultan Abdul Halim HospitalSungai PetaniKedahقيد التجنيد

Moldova

المنشأةالمدينةالولاية أو المنطقةالحالة
PMSI Emergency Medicine InstituteChisinauقيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Velocity Clinical Research, AnnapolisAnnapolisMarylandقيد التجنيد
Sinai Hospital of Baltimore, Inc.BaltimoreMarylandقيد التجنيد
Boston Medical CenterBostonMassachusettsقيد التجنيد
Tufts Medical CenterBostonMassachusettsقيد التجنيد
University of CincinnatiCincinnatiOhioقيد التجنيد
The Ohio State University Wexner Medical CenterColumbusOhioقيد التجنيد
Ohio Clinical TrialsColumbusOhioقيد التجنيد
South Florida Joint Replacement CenterDeerfield BeachFloridaقيد التجنيد
Duke University Health System (Duke Health), Duke University HospitalDurhamNorth Carolinaقيد التجنيد
HD Research - Memorial Hermann VillageHoustonTexasمكتمل
NextStage Clinical Research, All American Orthopedics and Sports MedicineHoustonTexasقيد التجنيد
The Orthopaedic Research Foundation, Inc.IndianapolisIndianaقيد التجنيد
Horizon Clinical ResearchLa MesaCaliforniaقيد التجنيد
Sky Ridge Medical CenterLone TreeColoradoقيد التجنيد
Medical Research of Westchester - MPLUS Research NetworkMiamiFloridaقيد التجنيد
University of PittsburghPittsburghPennsylvaniaقيد التجنيد
Eximia Equihealth Research-Raleigh. LLCRaleighNorth Carolinaقيد التجنيد
The Vein and Vascular Center at Raleigh RadiologyRaleighNorth Carolinaقيد التجنيد
Eisenhower Medical CenterRancho MirageCaliforniaقيد التجنيد
Carilion ClinicRoanokeVirginiaقيد التجنيد
University of Rochester Medical CenterRochesterNew Yorkقيد التجنيد
Endeavor Clinical TrialsSan AntonioTexasمسحوب
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)San AntonioTexasقيد التجنيد
Endeavor HealthSkokieIllinoisقيد التجنيد
Larkin Community Hospital South MiamiSouth MiamiFloridaقيد التجنيد
Spokane Joint Replacement CenterSpokaneWashingtonقيد التجنيد
Phoenix Clinical ResearchTamaracFloridaقيد التجنيد
Holy Name Medical CenterTeaneckNew Jerseyقيد التجنيد
NextStage Clinical Research, St. Francis Medical ParkWichitaKansasقيد التجنيد
Coastal Vascular Institute, PAWilmingtonNorth Carolinaقيد التجنيد

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 14 سبتمبر 2026

    أُضيف موقع

    2 sites added (36 total)

    3436

  2. 19 أغسطس 2026

    أُضيف موقع

    2 sites added (34 total)

    3234

السجل: ClinicalTrials.gov · NCT########

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