API-CAT STUDY for APIxaban Cancer Associated Thrombosis
API-CAT
Long-term Treatment of Cancer Associated VTE: Reduced vs Full Dose of Apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis
1 other identifier
interventional
1,766
11 countries
114
Brief Summary
The main objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent venous thromboembolism (VTE) in patients with active cancer who have completed at least 6 months of anticoagulant therapy for treating a documented index event of proximal deep venous thrombosis (DVT) (symptomatic or incidental) or pulmonary embolism (symptomatic or incidental).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2018
Longer than P75 for phase_3
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 2, 2018
CompletedStudy Start
First participant enrolled
October 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2024
CompletedFebruary 6, 2025
February 1, 2025
5.9 years
September 28, 2018
February 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of an an adjudicated composite endpoint
The incidence of an adjudicated composite of recurrent symptomatic VTE (proximal and/or distal DVT and/or symptomatic PE and/or upper limb or central venous catheter thrombosis or incidental VTE (proximal DVT or PE), or death due to PE during the treatment period. Incidental VTE is defined as proximal DVT or PE detected by imaging incidentally when a patient undergoes imaging studies as standard of care for the management of the malignancy or other reasons but not for a VTE suspicion.
During the treatment period (12 months)
Secondary Outcomes (6)
The incidence of adjudicated major and clinically relevant non-major bleeding
During the treatment period (12 months)
Recurrent symptomatic VTE
During the treatment period (12 months)
VTE related-death
During the treatment period (12 months)
All-cause death
During the treatment period (12 months)
Adjudicated major bleeding.
During the treatment period (12 months)
- +1 more secondary outcomes
Study Arms (2)
Apixaban film coated tablets 2.5 mg
ACTIVE COMPARATORPatients randomized in the apixaban reduced dose group will receive an apixaban 2.5 mg tablet and a placebo of apixaban 5 mg tablet, twice daily for 12 months.
Apixaban film coated tablets 5 mg
ACTIVE COMPARATORPatients randomized in the apixaban full dose group will receive a placebo of apixaban 2.5 mg tablet and an apixaban 5 mg tablet, twice daily for 12 months.
Interventions
Subjects will be randomized (1:1 ratio) to apixaban 5 mg bid (full dose) or apixaban 2.5 mg bid (reduced-dose) using a centralized IWRS (double blind study).
Eligibility Criteria
You may qualify if:
- Signed written informed consent
- Any cancer diagnosed histologically (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intra-cerebral metastasis)
- Objectively documented index event : Symptomatic or incidental proximal lower-limb, iliac, inferior vena cava DVT or symptomatic or incidental pulmonary embolism in a segmental or larger pulmonary artery or incidental PE in a segmental or larger pulmonary artery
- Proximal DVT is defined as DVT that involves at least the popliteal vein or a more proximal vein, demonstrated by imaging with compression ultrasound (CUS), including grey-scale or color-coded Doppler, or ascending contrast venography or contrast enhanced computed tomography or magnetic resonance imaging
- PE has to be demonstrated by imaging as follows:
- an intraluminal filling defect in segmental or more proximal branches on contrast enhanced chest computed tomography or on computed tomography pulmonary angiography; or
- an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram; or
- a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
- Incidental VTE is defined as proximal DVT or PE detected by imaging incidentally when a patient undergoes imaging studies as standard of care for the management of his or her malignancy or other reasons but not for a VTE suspicion(e.g. cancer diagnosis or staging).
- Completed at least 6 months of anticoagulant therapy at therapeutic dosage (whatever the drug and the dosing),or completed assigned a clinical trial study treatment, for the treatment of the index event and patient still receiving anticoagulant treatment 6 months after occurrence of the VTE index
- No objectively documented symptomatic recurrence of VTE between the index event and randomization.
- Anticipated duration of anticoagulant treatment of at least 12 months at the time of randomization
- Patient affiliated to social security for French centers.
You may not qualify if:
- WOCBP who are unwilling or unable to use an acceptable method of birth control \[such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)\] to avoid pregnancy for the entire study
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to investigational product administration
- Isolated sub-segmental (incidental or symptomatic) PE without associated DVT
- Isolated distal DVT of the legs
- Isolated upper-extremity DVT or superior vena cava thrombosis
- Isolated visceral thrombosis
- Isolated catheter thrombosis
- Objectively documented symptomatic recurrence of VTE after the index event under anticoagulant treatment
- VTE during anticoagulant treatment given at therapeutic dosage
- Subjects with indications for long-term treatment with a VKA, such as:
- Mechanical heart valve
- Antiphospholipid syndrome
- Subjects with indication for long-term anticoagulation with a VKA or a DOAC at therapeutic dosage
- Conditions increasing the risk of serious bleeding
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Bristol-Myers Squibbcollaborator
Study Sites (114)
Medical university of Graz
Graz, Austria
Medical university of Innsbruck
Innsbruck, Austria
Ordensklinikum Linz gmbH Elisabethinen
Linz, Austria
Medical university of Vienna
Vienna, Austria
Erasmus Hospital Brussel
Brussels, Belgium
Institut Roi Albert II
Brussels, Belgium
AZ Groeninge
Kortrijk, Belgium
Uz Leuven
Leuven, Belgium
CHC Saint-Joseph
Liège, Belgium
CHR de la Citadelle
Liège, Belgium
CHU de Liège
Liège, Belgium
University of Calgary
Calgary, T2N 2T9, Canada
University of Alberta
Edmonton, AB T6G 2R3, Canada
Ottawa Hospital Research Institute OTTAWA
Ottawa, ON K1Y 4E9, Canada
Toronto General Hospital
Toronto, M5G2C4, Canada
Diamond Health Care Centre
Vancouver, BC V5Z 1M9, Canada
C.H.U. D'Amiens Picardie
Amiens, 80054, France
Chu D'Angers
Angers, 49033, France
HÔPITAL PRIVÉ ARRAS LES BONNETTES - Espace Artois Santé
Arras, 62012, France
Centre Hospitalier d'Avignon
Avignon, 84000, France
Institut Sainte Catherine
Avignon, 84918, France
Hopital Jean Minjoz
Besançon, 25030, France
Hôpital AVICENNE - APHP
Bobigny, 93009, France
Hopital Saint Andre
Bordeaux, 33075, France
Institut Bergonie
Bordeaux, 33076, France
Hôpital d'Instruction des Armées Clermont Tonnerre
Brest, 29240, France
Chru Brest - Hopital Morvan
Brest, 29609, France
Chru Brest- Hopital Cavale Blanche
Brest, 29609, France
Centre François Baclesse
Caen, 14000, France
Centre de Recherche Clinique
Caen, 14033, France
Hopital Cote de Nacre
Caen, 14033, France
Clinique Du Parc
Castelnau-le-Lez, 34171, France
Centre hospitalier Métropole Savoie
Chambéry, 73000, France
Ch Cholet
Cholet, 49300, France
Hia Percy
Clamart, 92190, France
Hopital Gabriel Montpied
Clermont-Ferrand, 63003, France
Hôpital BEAUJON - APHP
Clichy, 92110, France
Hôpital Henri Mondor
Créteil, 94000, France
Hôpital HENRI MONDOR - APHP
Créteil, 94010, France
CHU DIJON BOURGOGNE - Hôpital François Mitterrand
Dijon, 21079, France
Chu de Grenoble
Grenoble, 38043, France
Chd Vendee
La Roche-sur-Yon, 85025, France
Centre Hospitalier Du Mans
Le Mans, 72037, France
Centre hospitalier Emile Roux
Le Puy-en-Velay, 43000, France
Chu de Limoges
Limoges, 87042, France
Centre Leon Berard
Lyon, 69008, France
Hôpital Prive Jean Mermoz
Lyon, 69008, France
Clinique de l'Infirmerie Protestante de Lyon
Lyon, 69300, France
Hopital La Timone Adultes
Marseille, 13385, France
Groupe hospitalier sud Ile de France
Melun, 77000, France
Hopital Saint- Eloi
Montpellier, 34000, France
C.H. Des Pays de Morlaix
Morlaix, 29600, France
Centre D Oncologie de Gentilly
Nancy, 54000, France
CHU DE Nantes - Site Hotel Dieu
Nantes, 44035, France
Chu de Nice
Nice, 06001, France
Institut Curie
Paris, 75005, France
Hôpital Saint Antoine - APHP
Paris, 75012, France
Hôpital PITIE SALPETRIERE - APHP
Paris, 75013, France
Hôpital COCHIN - APHP
Paris, 75014, France
Hôpital GEORGES POMPIDOU - APHP
Paris, 75015, France
Hôpital Bichat Claude Bernard
Paris, 75018, France
Hopital Tenon - Aphp
Paris, 75020, France
Hopital Saint-Joseph
Paris, 75674, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495, France
Polyclinique de Courlancy
Reims, 51057, France
CHU de Rennes
Rennes, 35000, France
Centre Anti-Cancereux E. Marquis
Rennes, 35042, France
Chu de Rouen - Hopital Charles Nicolle
Rouen, 76038, France
Centre Rene Huguenin
Saint-Cloud, 92210, France
Hôpital Nord
Saint-Etienne, 42055, France
C.H.I Poissy-Saint Germain
Saint-Germain-en-Laye, 78105, France
Centre Hospitalier de Saint Malo
St-Malo, 35400, France
Clinique de l' Estrée
Stains, 93240, France
Clinique Saint Anne
Strasbourg, 67000, France
Centre Paul Strauss
Strasbourg, 67085, France
Hopital Foch
Suresnes, 92151, France
Chi de Toulon La Seyne
Toulon, 83056, France
Iuct Oncopole
Toulouse, 31059, France
Hopital Andre Mignot
Versailles, 78000, France
L'Hôpital Nord-Ouest
Villefranche-sur-Saône, 69655, France
Hôpital Paul Brousse - APHP
Villejuif, 94800, France
Institut Gustave Roussy
Villejuif, 94805, France
Médipôle Hôpital Mutualiste
Villeurbanne, 69616, France
Hopital Louis Mourier - APHP
Colombes, Île-de-France Region, 92700, France
Athens School of Medicine
Athens, Greece
National and Kapodistrian University of Athens ALEXANDRA Hospital
Athens, Greece
University General Hospital "Attikon"
Athens, Greece
University of Athens
Athens, Greece
Ospedale di Castelfranco Veneto
Castelfranco Veneto, Italy
Opedale clinicizzato colle dell'ara
Chieti, Italy
Universita di Perugia
Perugia, Italy
Amsterdam university medical center
Amsterdam, Netherlands
Gelre Ziekenhuizen Apeldoorn
Apeldoorn, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Tergooi Hospital Hilversum
Hilversum, Netherlands
Leiden university medical center
Leiden, Netherlands
Diakonessenhuis
Utrecht, Netherlands
Centre of postgraduate medical education at the european health centre Otwock
Otwock, Poland
Hospital genarl Univ de Albacete
Albacete, Spain
Hospital Virgen de los lirios
Alicante, Spain
Fundacio Hospital de L'Esperit Sant
Barcelona, Spain
Hospital universitari Germans trias i Pujol
Barcelona, Spain
Parc Santari Sant Joan de Deu - Hospital general
Barcelona, Spain
Hospital general Universitario Santa Lucia
Cartagena, Spain
Hospital general universitario de ciudad real
Ciudad Real, Spain
Hospital Olot i Comarcal de ma Garrotxa
Girona, Spain
Hospital universitari de Girona
Girona, Spain
Hospital universitario Infanta Sofia
Madrid, Spain
Hospital universitario Virgen del Rocio
Seville, Spain
Istituto Oncologico della svizzera Italiana
Bellinzona, Switzerland
Hopitaux universitaires de Genève
Geneva, Switzerland
Lausanne university hospital - CHUV
Lausanne, Switzerland
Queens centre castle hill hospital
Cottingham, United Kingdom
Related Publications (2)
Mahe I, Chapelle C, Girard P, Carrier M, Palomares LJ, Samama CM, Helfer H, Gerotziafas G, Laporte S, Vicaut E, Mismetti P; API-CAT Study Group; API-CAT Investigators. Predictors of clinically relevant bleeding during extended anticoagulation for cancer-associated venous thromboembolism (API-CAT): a post-hoc analysis of a randomised, non-inferiority trial. Lancet Haematol. 2026 Jan;13(1):e41-e48. doi: 10.1016/S2352-3026(25)00291-1. Epub 2025 Dec 6.
PMID: 41365312DERIVEDMahe I, Carrier M, Mayeur D, Chidiac J, Vicaut E, Falvo N, Sanchez O, Grange C, Monreal M, Lopez-Nunez JJ, Otero-Candelera R, Le Gal G, Yeo E, Righini M, Robert-Ebadi H, Huisman MV, Klok FA, Westerweel P, Agnelli G, Becattini C, Bamias A, Syrigos K, Szmit S, Torbicki A, Verhamme P, Maraveyas A, Cohen AT, Ay C, Chapelle C, Meyer G, Couturaud F, Mismetti P, Girard P, Bertoletti L, Laporte S; API-CAT Investigators. Extended Reduced-Dose Apixaban for Cancer-Associated Venous Thromboembolism. N Engl J Med. 2025 Apr 10;392(14):1363-1373. doi: 10.1056/NEJMoa2416112. Epub 2025 Mar 29.
PMID: 40162636DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guy Meyer, Pr
APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2018
First Posted
October 2, 2018
Study Start
October 11, 2018
Primary Completion
September 6, 2024
Study Completion
October 20, 2024
Last Updated
February 6, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share