Clinical trial • Phase IV • Cardiology
APIXABAN for Venous thromboembolism
Phase IV trial of APIXABAN for Venous thromboembolism.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Venous thromboembolism
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule|Peptide/protein/enzyme|Other
Key dates
- Initial CTIS Submission Date
- 29-04-2024
- First CTIS Authorization Date
- 12-08-2024
Trial design
Randomised, open-label, comparators include: nadroparin calcium (solution for injection in pre-filled syringe; max daily dose examples in documentation: 2850 iu, 5700 iu), dalteparin sodium (solution for injection in pre-filled syringe; max daily dose examples: 2500 iu, 5000 iu), dabigatran (capsule; max daily dose 220 mg), enoxaparin sodium (solution for injection in pre-filled syringe; max daily dose examples: 2000 iu, 4000 iu), rivaroxaban (film coated tablets; max daily dose 10 mg), apixaban (film coated tablets; doses referenced: 5 mg and 10 mg entries). detailed schedules are not specified in the ctis data.-controlled Phase IV trial in Netherlands.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Comparators include: NADROPARIN CALCIUM (solution for injection in pre-filled syringe; max daily dose examples in documentation: 2850 IU, 5700 IU), DALTEPARIN SODIUM (solution for injection in pre-filled syringe; max daily dose examples: 2500 IU, 5000 IU), DABIGATRAN (capsule; max daily dose 220 mg), ENOXAPARIN SODIUM (solution for injection in pre-filled syringe; max daily dose examples: 2000 IU, 4000 IU), RIVAROXABAN (film coated tablets; max daily dose 10 mg), APIXABAN (film coated tablets; doses referenced: 5 mg and 10 mg entries). Detailed schedules are not specified in the CTIS data.
- Target Sample Size
- 10078
- Trial Duration For Participant
- 90
Eligibility
Recruits 10078 No vulnerable populations selected; participants must be aged 18 years or older; insufficient mental or physical ability excludes participation; sufficient knowledge of Dutch is required; informed consent is obtained from adult participants (see adult SIS and ICF documents)..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- No vulnerable populations selected; participants must be aged 18 years or older; insufficient mental or physical ability excludes participation; sufficient knowledge of Dutch is required; informed consent is obtained from adult participants (see adult SIS and ICF documents).
Inclusion criteria
- {"criterion_text":"- Subjects scheduled to undergo an elective Total Hip Arthroplasty or Total Knee Arthroplasty"}
- {"criterion_text":"- Subjects aged 18 years or older"}
Exclusion criteria
- {"criterion_text":"- Primary arthroplasty for fractures"}
- {"criterion_text":"- Patients using thrombocyte aggregation inhibitors that cannot be temporarily discontinued at the discretion of their treating physician"}
- {"criterion_text":"- Revision surgery"}
- {"criterion_text":"- Hemiarthroplasty"}
- {"criterion_text":"- Pregnancy"}
- {"criterion_text":"- Current use of therapeutic anticoagulant therapy of any type (e.g., LMWH, DOAC, vitamin K antagonist)"}
- {"criterion_text":"- A contraindication for either study drug"}
- {"criterion_text":"- Insufficient knowledge of the Dutch language"}
- {"criterion_text":"- Insufficient mental or physical ability to fulfil trial requirements"}
- {"criterion_text":"- Active malignancy (i.e. cancer diagnosis within six months before surgery (excluding basal-cell or squamous-cell carcinoma of the skin), recently recurrent or progressive cancer or any cancer that required anti-cancer treatment within six months before surgery)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of VTEs in the first 3 months postoperative","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of major bleeds in the first 3 months postoperative.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Clinically relevant non major bleeding","definition_or_measurement_approach":""}
- {"endpoint_text":"- Impact of events on QALY’s","definition_or_measurement_approach":""}
- {"endpoint_text":"- Healthcare costs","definition_or_measurement_approach":""}
- {"endpoint_text":"- Prosthetic joint infections","definition_or_measurement_approach":""}
- {"endpoint_text":"- Patient reported outcome measures","definition_or_measurement_approach":""}
- {"endpoint_text":"- Myocardial infarction","definition_or_measurement_approach":""}
- {"endpoint_text":"- Ischemic stroke","definition_or_measurement_approach":""}
- {"endpoint_text":"- Death","definition_or_measurement_approach":""}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 10078
- Recruitment Window Months
- 65
- Consent Approach
- Informed consent obtained from adult participants (participants must be ≥18 years). Adult Subject Information Sheet (SIS) and Informed Consent Form (ICF) documents are provided (documents titled 'L1_ SIS and ICF adults DISTINCT'). Materials require sufficient knowledge of Dutch (insufficient knowledge of the Dutch language is an exclusion criterion). No assent for minors (children excluded).
Methods
- Storyboard animation video (title: 'K2_ Recruitment material Storyboard Animation video general') — digital audiovisual material to inform potential participants.
- Printed flyer (title: 'K2_ Recruitment material flyer') — paper-based recruitment material for patients.
- Information on LUMC website (title: 'K2_ Recruitment material information website LUMC') — online institutional website information targeting patients in the Netherlands.
- Recruitment procedure NL (title: 'K1_ recruitment procedure NL') — documented country-specific recruitment procedure for the Netherlands.
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 10078
Netherlands
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 633
- Number Of Sites
- 15
- Number Of Participants
- 10078
Sites
- Site Name
- Reinier Haga Groep Orthopedisch Centrum B.V.
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- S.B.W. Vehmeijer
- Principal Investigator Email
- s.vehmeijer@rhoc.nl
- Contact Person Name
- S.B.W. Vehmeijer
- Contact Person Email
- s.vehmeijer@rhoc.nl
- Site Name
- St. Antonius Ziekenhuis
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- L. Kaas
- Principal Investigator Email
- L.Kaas@antoniusziekenhuis.nl
- Contact Person Name
- L. Kaas
- Contact Person Email
- L.Kaas@antoniusziekenhuis.nl
- Site Name
- ZorgSaam Ziekenhuis
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- M.P. van de Kerkhove
- Principal Investigator Email
- m.vandekerkhove@zzv.nl
- Contact Person Name
- M.P. van de Kerkhove
- Contact Person Email
- m.vandekerkhove@zzv.nl
- Site Name
- Stichting OLVG
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- R.W. Poolman
- Principal Investigator Email
- r.w.poolman@olvg.nl
- Contact Person Name
- R.W. Poolman
- Contact Person Email
- r.w.poolman@olvg.nl
- Site Name
- Bergman Clinics Nederland B.V.
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- J.I. Wiegerinck
- Principal Investigator Email
- j.wiegerinck@bergmanclinics.nl
- Contact Person Name
- J.I. Wiegerinck
- Contact Person Email
- j.wiegerinck@bergmanclinics.nl
- Site Name
- Stichting Elisabeth-Tweesteden Ziekenhuis
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- P.W. van Egmond
- Principal Investigator Email
- p.vanegmond@etz.nl
- Contact Person Name
- P.W. van Egmond
- Contact Person Email
- p.vanegmond@etz.nl
- Site Name
- Alrijne Zorggroep Stichting
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- R. Mahdad
- Principal Investigator Email
- rmahdad@alrijne.nl
- Contact Person Name
- R. Mahdad
- Contact Person Email
- rmahdad@alrijne.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Clinical epidemiology
- Principal Investigator Name
- B. Nemeth
- Principal Investigator Email
- b.nemeth@lumc.nl
- Contact Person Name
- B. Nemeth
- Contact Person Email
- b.nemeth@lumc.nl
- Site Name
- Zuyderland Medisch Centrum Stichting
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- W.L.W. van Hemert
- Principal Investigator Email
- w.vanhemert@zuyderland.nl
- Contact Person Name
- W.L.W. van Hemert
- Contact Person Email
- w.vanhemert@zuyderland.nl
- Site Name
- Stichting St. Anna Zorggroep
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- M. Siebelt
- Principal Investigator Email
- m.siebelt@st-anna.nl
- Contact Person Name
- M. Siebelt
- Contact Person Email
- m.siebelt@st-anna.nl
- Site Name
- Isala Klinieken Stichting
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- H.B. Ettema
- Principal Investigator Email
- h.b.ettema@isala.nl
- Contact Person Name
- H.B. Ettema
- Contact Person Email
- h.b.ettema@isala.nl
- Site Name
- Bravis Ziekenhuis
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- G. Meermans
- Principal Investigator Email
- geertmeermans@hotmail.com
- Contact Person Name
- G. Meermans
- Contact Person Email
- geertmeermans@hotmail.com
- Site Name
- Equipe Zorgbedrijven Nederland B.V.
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- S.B.W. Vehmeijer
- Principal Investigator Email
- info@equipezorgbedrijven.nl
- Contact Person Name
- S.B.W. Vehmeijer
- Contact Person Email
- info@equipezorgbedrijven.nl
- Site Name
- Gelre Hospitals
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- B. Boesenach
- Principal Investigator Email
- b.boesenach@gelre.nl
- Contact Person Name
- B. Boesenach
- Contact Person Email
- b.boesenach@gelre.nl
- Site Name
- Groene Hart Ziekenhuis
- Department Name
- Orthopedic surgery
- Principal Investigator Name
- R. Onstenk
- Principal Investigator Email
- ron.onstenk@ghz.nl
- Contact Person Name
- R. Onstenk
- Contact Person Email
- ron.onstenk@ghz.nl
Sponsor
Primary sponsor
- Full Name
- Academisch Ziekenhuis Leiden
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- APIXABAN
- Active Substance
- APIXABAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- marketingAuthNumber: - (prodAuthStatus: 2)
- Maximum Dose
- 5 mg (entries include 5 mg and 10 mg formulations; maxDailyDoseAmount entries show 5 and 10 mg in product records)
- Investigational Product Name
- NADROPARIN CALCIUM
- Active Substance
- NADROPARIN CALCIUM
- Modality
- Other
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- marketingAuthNumber: - (prodAuthStatus: 2)
- Maximum Dose
- examples in product records: 2850 IU, 5700 IU
- Investigational Product Name
- DALTEPARIN SODIUM
- Active Substance
- DALTEPARIN SODIUM
- Modality
- Other
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- marketingAuthNumber: - (prodAuthStatus: 2)
- Maximum Dose
- examples in product records: 2500 IU, 5000 IU
- Investigational Product Name
- ENOXAPARIN SODIUM
- Active Substance
- ENOXAPARIN SODIUM
- Modality
- Other
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- marketingAuthNumber: - (prodAuthStatus: 2)
- Maximum Dose
- examples in product records: 2000 IU, 4000 IU
- Investigational Product Name
- DABIGATRAN
- Active Substance
- DABIGATRAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL (capsule)
- Route
- ORAL
- Authorisation Status
- marketingAuthNumber: - (prodAuthStatus: 2)
- Maximum Dose
- maxDailyDoseAmount: 220 mg (as recorded)
- Investigational Product Name
- RIVAROXABAN
- Active Substance
- RIVAROXABAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- marketingAuthNumber: - (prodAuthStatus: 2)
- Maximum Dose
- maxDailyDoseAmount: 10 mg (as recorded)
- Investigational Product Name
- ANDEXANET ALFA
- Active Substance
- ANDEXANET ALFA
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- marketingAuthNumber: - (prodAuthStatus: 2)
- Maximum Dose
- maxDailyDoseAmount: 1760 mg (as recorded)
- Investigational Product Name
- Cofact 250 IE (Solution for injection)
- Active Substance
- HUMAN COAGULATION FACTOR IX; PROTEIN C; HUMAN COAGULATION FACTOR VII; PROTEIN S; HUMAN COAGULATION FACTOR II; HUMAN COAGULATION FACTOR X
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- marketingAuthNumber: RVG 17060 (NL/H/0859/001) for Cofact 250 IE
- Maximum Dose
- maxDailyDoseAmount: 2500 U (as recorded)
- Investigational Product Name
- Cofact 500 IE (Solution for injection)
- Active Substance
- HUMAN COAGULATION FACTOR IX; PROTEIN C; HUMAN COAGULATION FACTOR VII; PROTEIN S; HUMAN COAGULATION FACTOR II; HUMAN COAGULATION FACTOR X
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- marketingAuthNumber: RVG 17060 (NL/H/0859/002) for Cofact 500 IE
- Maximum Dose
- maxDailyDoseAmount: 2500 U (as recorded)
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