Study Comparing Abelacimab and Apixaban for Preventing Blood Clots in Cancer Patients

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What is this study about?

This clinical trial is focused on studying a condition known as venous thromboembolism (VTE), which involves the formation of blood clots in the veins. The study is particularly interested in patients who have VTE associated with cancer. Two treatments are being compared in this trial: Abelacimab, a solution for infusion, and Apixaban, a film-coated tablet. Abelacimab is administered through an infusion, which means it is given directly into the bloodstream, while Apixaban is taken orally as a tablet.

The purpose of the study is to evaluate whether Abelacimab is as effective as Apixaban in preventing the recurrence of VTE in patients with cancer over a period of six months. If Abelacimab proves to be at least as effective, the study will further assess if it might be even better. Participants in the study will receive either Abelacimab or Apixaban and will be monitored for any recurrence of VTE and any bleeding events during the six-month period.

This trial is designed to provide valuable information on the effectiveness and safety of these treatments for patients with cancer-related VTE. The study is open-label, meaning that both the participants and the researchers know which treatment is being administered, but the evaluation of the results is blinded to ensure unbiased assessment. The trial aims to help improve treatment options for patients dealing with this serious condition.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment being studied.

2 treatment with abelacimab

Participants in this group receive abelacimab, which is administered as a 150 mg/ml solution for infusion. This medication is given through a subcutaneous injection, which means it is injected under the skin.

The treatment aims to prevent the recurrence of venous thromboembolism (VTE) in patients with cancer.

3 treatment with apixaban

Participants in this group receive apixaban, known by the brand name Eliquis, in the form of 5 mg film-coated tablets. This medication is taken orally, meaning it is swallowed.

The treatment is designed to prevent the recurrence of venous thromboembolism (VTE) in patients with cancer.

4 treatment duration

Both treatments are administered for a period of 6 months. During this time, the effectiveness of each medication in preventing VTE recurrence is evaluated.

5 evaluation of outcomes

The primary outcome measured is the time to the first event of VTE recurrence, which is centrally adjudicated, meaning it is assessed by a central committee to ensure accuracy and consistency.

This evaluation occurs throughout the 6-month treatment period.

Who Can Join the Study?

  • Must be a male or female who is at least 18 years old or the legal age of maturity in their country.
  • Must have a confirmed diagnosis of cancer, which means the cancer has been identified through a tissue sample or imaging tests. This does not include only basal-cell or squamous-cell skin cancer. The cancer should be active, meaning it is growing locally, spreading to nearby areas, or has spread to other parts of the body. Alternatively, the patient should be currently receiving or have received cancer treatment like radiation, chemotherapy, hormone therapy, or any other cancer treatment in the last 6 months.
  • Must have a confirmed case of venous thromboembolism (VTE), which is a condition where blood clots form in the veins. This includes clots in the deep veins of the lower leg (like the popliteal, femoral, iliac, or inferior vena cava veins) or a pulmonary embolism (PE), which is a clot in the lung arteries. The patient should be eligible within 120 hours (5 days) from the diagnosis of the VTE.
  • Must be indicated for anticoagulation therapy, which is treatment to prevent blood clots, with a therapeutic dose of DOAC (a type of blood thinner) for at least 6 months.
  • Must be able to provide written informed consent, meaning they understand the study and agree to participate.

Who Cannot Join the Study?

  • Patients who have a history of venous thromboembolism (VTE), which is a condition where blood clots form in the veins.
  • Patients who are not within the specified age range for the study.
  • Patients who do not belong to the specific clinical trial group required for the study.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population, meaning they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Haga Hospital Hague The Netherlands
Centre Hospitalier Universitaire Rouen Rouen France
IRCCS Humanitas Research Hospital Rozzano Italy
University Of Debrecen Debrecen Hungary
Beaumont Hospital Dublin Ireland
Virgen del Rocío University Hospital Sevilla Spain
Medical University Of Vienna Vienna Austria
Amsterdam UMC Amsterdam The Netherlands
Assistance Publique Hopitaux De Marseille Marseille France
Akershus University Hospital Lorenskog Norway
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
Stichting Radboud University Medical Center Nijmegen The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Clinico San Carlos Madrid Spain
CHRU De Nancy Vandoeuvre Les Nancy France
Sykehuset Oestfold HF Kalnes Graalum Norway
Medical University Of Graz Graz Austria
Klinikum der Universitaet Muenchen AöR Munich Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Universitaet Leipzig Leipzig Germany
Hospital De La Santa Creu I Sant Pau Barcelona Spain
Centre Hospitalier Regional Et Universitaire De Brest Brest France
University Medical Center Hamburg-Eppendorf Hamburg Germany
Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Oncopole Claudius Regaud Toulouse France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Universitair Medisch Centrum Groningen Groningen The Netherlands
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario Marques De Valdecilla Santander Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Centre Hospitalier Regional D’Angers Angers France
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Hospital Universitario Virgen De Las Nieves Granada Spain
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France
Hôpitaux Universitaires Strasbourg – Hôpital de Hautepierre STRASBOURG, Alsace France
Pauls Stradins Clinical University Hospital Riga Latvia
Parc Tauli Hospital Universitari Sabadell Spain
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Orszagos Onkologiai Intezet Budapest Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz Kecskemet Hungary
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Institut de Cancérologie Hématologie Universitaire de Saint Etienne (iCHUSE) Saint Priest En Jarez France
Fakultni Thomayerova nemocnice Prague Czechia
Centre Hospitalier Et Universitaire De Limoges Limoges France
Centre Hospitalier Universitaire De Dijon Dijon France
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Universita’ Di Pisa Pisa Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Hospital Universitario Lucus Augusti Lugo Spain
Azienda USL IRCCS Di Reggio Emilia Reggio Emilia Italy
University Of Pecs Pecs Hungary
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Azienda Ospedaliero Universitaria Parma Parma Italy
CHU Gabriel-Montpied Clermont Ferrand France
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Leids Universitair Medisch Centrum (LUMC) Leiden The Netherlands
Hospital Santa Maria Della Misericordia Perugia Italy
Cork University Hospital Cork Ireland
Stichting OLVG Amsterdam The Netherlands
University Hospital Limerick Limerick Ireland
Hospital Universitario Del Vinalopo Elche Spain
Hospital Universitario De Jaen Jaen Spain
Hospital Universitario Infanta Leonor Madrid Spain
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Region Vaesternorrland Sundsvall Sweden
Rode Kruis Ziekenhuis B.V. Beverwijk The Netherlands

Other Sites

Site Name City Country Status
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Azienda Sanitaria Locale Cn2 Alba-Bra Alba Italy
Bon Secours Hospital Cork Cork Ireland
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz Budapest Hungary
Centre Hospitalier Du Puy Le Puy-En-Velay France
Krqjnipttb Fgyn Futeid Krexhn Kistarcsa Hungary
Ngm Lpn Gtezlbyjxh Tuvyswtxnvcgv Gnnt Wiener Neustadt Austria
Agvsffa Otwwuxemkptreqdskpgjkexdc Dn Ceowtwb Cosenza Italy
Npdawmfkh Nz Paxzz semohc Nova Ves Pod Plesi Czechia
Pcalma fkoq Gpdjtpogkwqan Goerlitz Germany
Oxdfqemk Spc Gjiuxpmy E Pofkz Venice Italy
Cikvxh Hyijqmdfahx Pmfn de Meijaqn Morlaix France
Mcihjzh Mtmgxef Ccyxda Amersfoort The Netherlands
Lhmjqgta Rdtyjmkky Syofshyc Syp Liepaja Latvia
Shyuabyfqpqh Ktpjiibx Dbeidkn Dresden Germany
Tiskjlnerwjtrcjpzdt Hilversum The Netherlands
Awvtkkw Uxedw Lbbsvb Sucuf Smurrilcl N 8 Boqczu Vicenza Italy
Dkubwtzgcm reyerxqsi szclqncm Sqp Daugavpils Latvia
Mk Ankdifzg Cvrkks Cazikp Madrid Spain
Iybtfw Zwrnanjabv Rotterdam The Netherlands
Hictougk Ld Mdjplrety Sobo Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
02.12.2021
Czechia Czechia
Not recruiting
02.12.2021
France France
Not recruiting
02.12.2021
Germany Germany
Not recruiting
02.12.2021
Hungary Hungary
Not recruiting
02.12.2021
Ireland Ireland
Not recruiting
02.12.2021
Italy Italy
Not recruiting
02.12.2021
Latvia Latvia
Not recruiting
02.12.2021
Norway Norway
Not recruiting
02.12.2021
Spain Spain
Not recruiting
02.12.2021
Sweden Sweden
Not recruiting
02.12.2021
The Netherlands The Netherlands
Not recruiting
02.12.2021

Trial locations

Investigated Drugs:

Abelacimab is a medication being studied to see if it can prevent blood clots from coming back in patients who have cancer and have recently had a blood clot. The study is looking to see if abelacimab is at least as good as another medication in preventing these clots over a period of six months.

Apixaban is a medication that is already used to prevent blood clots from forming or getting worse. In this study, it is being used as a comparison to see how well abelacimab works in preventing blood clots in patients with cancer.

Investigated Diseases:

Venous Thromboembolism (VTE) – This condition involves the formation of blood clots in the veins, which can lead to complications if the clots travel to other parts of the body. It typically begins with a clot in a deep vein, often in the legs, known as deep vein thrombosis (DVT). If a part of this clot breaks off, it can travel to the lungs, causing a pulmonary embolism (PE). Symptoms may include swelling, pain, and redness in the affected area, as well as shortness of breath and chest pain if a PE occurs. The progression of VTE can vary, with some individuals experiencing recurrent episodes. It is important to monitor and manage the condition to prevent further complications.

Trial ID:
2023-509569-19-00
Protocol code:
ANT-007
NCT ID:
NCT05171049
Trial Phase:
Therapeutic use (Phase IV)

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