Clinical trial • Phase IV • Cardiology
APIXABAN for Post-operative atrial fibrillation (after CABG)
Phase IV trial of APIXABAN for Post-operative atrial fibrillation (after CABG).
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Post-operative atrial fibrillation (after CABG)
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 04-07-2024
- First CTIS Authorization Date
- 29-07-2024
Trial design
Randomised, brilique 60 mg film-coated tablets (ticagrelor) - comparator; clopidogrel 75 mg film-coated tablets - comparator; aspirin 500 mg coated tablets - comparator-controlled Phase IV trial across 16 sites in Germany.
- Randomised
- Yes
- Comparator
- Brilique 60 mg film-coated tablets (ticagrelor) - comparator; Clopidogrel 75 mg film-coated tablets - comparator; Aspirin 500 mg coated tablets - comparator
- Target Sample Size
- 2450
- Trial Duration For Participant
- 180
Eligibility
Recruits 2450 Patients under legal supervision or guardianship are excluded. 'Unable or unwilling to provide informed consent' is an exclusion. The trial enrols adults (≥18 years) only; isVulnerablePopulationSelected is false..
- Pregnancy Exclusion
- Pregnancy at the time of randomization
- Vulnerable Population
- Patients under legal supervision or guardianship are excluded. 'Unable or unwilling to provide informed consent' is an exclusion. The trial enrols adults (≥18 years) only; isVulnerablePopulationSelected is false.
Inclusion criteria
- {"criterion_text":"- Patients of age ≥18 years who undergo isolated CABG for coronary artery disease"}
- {"criterion_text":"- POAF that persists for >60 minutes or is recurrent (more than one episode) within 7 days after the index CABG"}
Exclusion criteria
- {"criterion_text":"- Clinical history of either permanent, persistent or paroxysmal atrial fibrillation"}
- {"criterion_text":"- Concomitant carotid artery endarterectomy during CABG"}
- {"criterion_text":"- Concomitant aortic root replacement during CABG"}
- {"criterion_text":"- Concomitant surgery for AF during CABG"}
- {"criterion_text":"- Liver cirrhosis or Child-Pugh Class C chronic liver disease"}
- {"criterion_text":"- Pharmacologic therapy with an investigational drug or device within 30-days prior to randomization or plan to enroll patient in an investigational drug or device trial during participation in this trial"}
- {"criterion_text":"- Pregnancy at the time of randomization"}
- {"criterion_text":"- Unable or unwilling to provide informed consent"}
- {"criterion_text":"- Unable or unwilling to comply wit the study treatment and followup"}
- {"criterion_text":"- Existence of underlying disease that limits life expectancy to less than one year"}
- {"criterion_text":"- Women of childbearing potential (within two years after the last spontaneous menstruation) without effective contraceptive measures (Implanon, injections, oral contraceptives, intrauterine devices, vasectomized partner) during study participation. (Participants using hormone-based preparations must be informed about possible interactions with the study medication)"}
- {"criterion_text":"- Any pre-existing clinical indication for long-term OAC"}
- {"criterion_text":"- Participation in other interventional studies"}
- {"criterion_text":"- Patients under legal supervision or guardianship"}
- {"criterion_text":"- Any absolute contraindication to OAC"}
- {"criterion_text":"- Planned use of post-operative dual antiplatelet therapy (DAPT)"}
- {"criterion_text":"- Cardiogenic shock"}
- {"criterion_text":"- Major perioperative complication occurring between CABG and randomization"}
- {"criterion_text":"- Concomitant mitral valve annuloplasty during CABG"}
- {"criterion_text":"- Concomitant valve surgery during CABG or prior valve surgery (including aortic, mitral, tricuspid or pulmonary)"}
- {"criterion_text":"- Concomitant mitral valve annuloplasty during CABG"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Primary effectiveness endpoint: composite of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) (deep venous thrombosis (DVT) and/or pulmonary embolism (PE))","definition_or_measurement_approach":"Composite of clinical thromboembolic events as listed (death, ischemic stroke, TIA, MI, systemic arterial thromboembolism, VTE [DVT and/or PE])."}
- {"endpoint_text":"- Primary safety endpoint: Bleeding Academic Research Consortium (BARC) type 3 or 5","definition_or_measurement_approach":"Bleeding classified using the Bleeding Academic Research Consortium (BARC) definitions; events of type 3 or 5 count toward the primary safety endpoint."}
Secondary endpoints
- {"endpoint_text":"- Composite of death, ischemic stroke, TIA, MI, or systemic arterial thromboembolism","definition_or_measurement_approach":"Composite assessed at 90 and 180 days after randomization (timepoints specified in translations)."}
- {"endpoint_text":"- Net clinical benefit (NCB)","definition_or_measurement_approach":"Defined as the integration of the primary effectiveness and safety endpoints at 90 days after randomization to capture overall risk/benefit."}
- {"endpoint_text":"- Incidence of the primary effectiveness and safety endpoints at 180 days after randomization","definition_or_measurement_approach":"Incidence measured at 180 days after randomization."}
- {"endpoint_text":"- Individual components of the primary effectiveness and safety endpoints at 90 d and 180 days after randomization","definition_or_measurement_approach":"Individual component events assessed at 90 and 180 days after randomization."}
- {"endpoint_text":"- Cardiovascular and non-cardiovascular mortality at 90 and180 days after randomization","definition_or_measurement_approach":"Mortality categorized by cause and assessed at 90 and 180 days."}
- {"endpoint_text":"- Incidence of BARC 2 bleeding at 90 and 180 days after randomization","definition_or_measurement_approach":"Bleeding events classified by BARC; incidence of BARC type 2 recorded at 90 and 180 days."}
- {"endpoint_text":"- Cardiac arrhythmias including recurrent symptomatic or asymptomatic AF requiring medical attention at 90 and 180 days after randomization","definition_or_measurement_approach":"Incidence of arrhythmias (including recurrent symptomatic or asymptomatic AF requiring medical attention) assessed at 90 and 180 days."}
- {"endpoint_text":"- Length of stay of index hospitalization","definition_or_measurement_approach":"Duration of initial hospitalization (index hospital stay) measured in days."}
- {"endpoint_text":"- Number and reasons for readmissions at 90 and 180 days after rendomization","definition_or_measurement_approach":"Counts and documented reasons for hospital readmissions up to 90 and 180 days after randomization."}
- {"endpoint_text":"- Hospital resource utilization at 180 days after surgey","definition_or_measurement_approach":"Assessment of hospital resource use (details not specified) up to 180 days post-randomization."}
- {"endpoint_text":"- Patients' convenience and satisfaction survey utilizing the Perception of Anticoagulation Treatment Questionnaire (PACT-Q2) at 90 days after randomization","definition_or_measurement_approach":"Patient-reported convenience and satisfaction measured using the PACT-Q2 instrument at 90 days."}
Recruitment
- Planned Sample Size
- 2450
- Recruitment Window Months
- 43
- Consent Approach
- Informed consent is required from participants (adults ≥18). 'Unable or unwilling to provide informed consent' is an exclusion. Subject information and informed consent form documents are provided (document titles present); no assent procedures for minors (trial enrols adults only).
Geography
- Total Number Of Sites
- 16
- Total Number Of Participants
- 750
Germany
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 11-06-2025
- Processing Time Days
- 330
- Number Of Sites
- 16
- Number Of Participants
- 750
Sites
- Site Name
- Friedrich-Schiller-Universitaet Jena
- Department Name
- Klinik für Herz- und Thoraxchirurgie
- Principal Investigator Name
- Torsten Doenst
- Contact Person Name
- Torsten Doenst
- Contact Person Email
- doenst@med.uni-jena.d
- Site Name
- Klinikum Oldenburg AöR
- Department Name
- Universitätsklinik für Herzchirurgie
- Principal Investigator Name
- Andreas Martens
- Contact Person Name
- Andreas Martens
- Contact Person Email
- herzchirurgie@klinikum-oldenburg.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Klinik und Poliklinik für Herzchirurgie
- Principal Investigator Name
- Farhad Bakhtiary
- Contact Person Name
- Farhad Bakhtiary
- Contact Person Email
- farhad.bakhtiary@ukbonn.de
- Site Name
- Barmherzige Brueder Trier gGmbH
- Department Name
- Herz- und Thoraxchirurgie
- Principal Investigator Name
- Terrence John Donovan
- Contact Person Name
- Terrence John Donovan
- Contact Person Email
- tj.donovan@bbtgruppe.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Universitätsklinik für Herz- und Thoraxchirurgie
- Principal Investigator Name
- Georg Awad
- Contact Person Name
- Georg Awad
- Contact Person Email
- george.awad@med.ovgu.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Universitäts-Herzzentrum Freiburg - Bad Krozingen
- Principal Investigator Name
- Yasir Al-Hamami
- Contact Person Name
- Yasir Al-Hamami
- Contact Person Email
- yasir.al.hamami@uniklinik-freiburg.de
- Site Name
- Herzzentrum Leipzig GmbH
- Department Name
- Klinik für Herzchirurgie
- Principal Investigator Name
- Michael A. Borger
- Contact Person Name
- Michael A. Borger
- Contact Person Email
- michael.borger@helios-gesundheit.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Klinik für Herz- und Gefäßchirurgie
- Principal Investigator Name
- Thomas Walther
- Contact Person Name
- Thomas Walther
- Contact Person Email
- thomas.walther@herz-frankfurt.de
- Site Name
- Kerckhoff-Klinik GmbH
- Department Name
- Herzzentrum / Abt. für Herzchirurgie und Chirurgische Intensivmedizin
- Principal Investigator Name
- Yeong-Hoon Choi
- Contact Person Name
- Yeong-Hoon Choi
- Contact Person Email
- y.choi@kerckhoff-klinik.de
- Site Name
- Martin-Luther-Universitaet Halle-Wittenberg
- Department Name
- University Hospital Halle, Dep. of Cardiac Surgery
- Principal Investigator Name
- Gabor Szabo
- Contact Person Name
- Gabor Szabo
- Contact Person Email
- gabor.szabo@uk-halle.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Herzchirurgische Klinik und Poliklinik
- Principal Investigator Name
- Dominik Joskowiak
- Contact Person Name
- Dominik Joskowiak
- Contact Person Email
- Dominik.joskowiak@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik für Herzchirurgie
- Principal Investigator Name
- Alexander Assmann
- Contact Person Name
- Alexander Assmann
- Contact Person Email
- Alexander.Assmann@med.uni-duesseldorf.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Klinik für Herzchirurgie
- Principal Investigator Name
- Payam Akhyari
- Contact Person Name
- Payam Akhyari
- Contact Person Email
- pakhyari@ukaachen.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- DHZB Deutsches Herzzentrum Berlin, Klinik für Herz-, Thorax- und Gefäßchirurgie
- Principal Investigator Name
- Stephan Jacobs
- Contact Person Name
- Stephan Jacobs
- Contact Person Email
- jacobs@dhzb.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Universitäres Herz- und Gefäßzentrum Hamburg
- Principal Investigator Name
- Johannes Petersen
- Contact Person Name
- Johannes Petersen
- Contact Person Email
- joh.petersen@uke.de
- Site Name
- Deutsches Herzzentrum Muenchen Klinikum Der Technischen Universitaet Muenchen
- Department Name
- Klinik für Herz- und Gefäßchirurgie
- Principal Investigator Name
- Felix With
- Contact Person Name
- Felix With
- Contact Person Email
- wirth@dhm.mhn.de
Sponsor
Primary sponsor
- Full Name
- Icahn School Of Medicine At Mount Sinai
- Organisation Type
- Educational Institution
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Eliquis 2.5 mg film-coated tablets
- Active Substance
- APIXABAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 2.5 mg (product strength)
- Maximum Dose
- 60 mg per day
- Investigational Product Name
- Pradaxa 75 mg hard capsules
- Active Substance
- DABIGATRAN ETEXILATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 75 mg (product strength)
- Maximum Dose
- 600 mg per day
- Investigational Product Name
- Xarelto 10 mg film-coated tablets
- Active Substance
- RIVAROXABAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 10 mg (product strength)
- Maximum Dose
- 30 mg per day
- Investigational Product Name
- Lixiana 15 mg film-coated tablets
- Active Substance
- EDOXABAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 15 mg (product strength)
- Maximum Dose
- 60 mg per day
- Investigational Product Name
- Brilique 60 mg film-coated tablets
- Active Substance
- TICAGRELOR
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 60 mg (product strength)
- Maximum Dose
- 90 mg per day
- Investigational Product Name
- Clopidogrel ratiopharm 75 mg film-coated tablets
- Active Substance
- CLOPIDOGREL
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 75 mg (product strength)
- Maximum Dose
- 75 mg per day
- Investigational Product Name
- Aspirin 500 mg überzogene Tabletten
- Active Substance
- ACETYLSALICYLIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 500 mg (product strength)
- Maximum Dose
- 325 mg per day
- Investigational Product Name
- Marcumar 3 mg Tabletten
- Active Substance
- PHENPROCOUMON
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 3 mg (product strength)
- Maximum Dose
- 9 mg per day
- Combination Treatment
- Yes
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