Clinical trial • Cardiology|Neurology
Edoxaban for Acute ischemic stroke
Clinical trial of Edoxaban for Acute ischemic stroke.
Overview
- Trial Therapeutic Area
- Cardiology|Neurology
- Trial Disease
- Acute ischemic stroke
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-11-2024
- First CTIS Authorization Date
- 17-01-2025
Trial design
Randomised, open-label, standard of care (soc) = antiplatelet therapy. comparator products listed: aspirine 100 mg (oral) and plavix (clopidogrel) 75 mg (oral). doses provided in product listings (aspirine 100 mg; plavix 75 mg). soc described as treatment with antiplatelets until study end or until af is detected. specific administration schedule not specified in ctis data.-controlled trial in Spain, Greece.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Standard of care (SOC) = antiplatelet therapy. Comparator products listed: Aspirine 100 mg (oral) and Plavix (clopidogrel) 75 mg (oral). Doses provided in product listings (Aspirine 100 mg; Plavix 75 mg). SOC described as treatment with antiplatelets until study end or until AF is detected. Specific administration schedule not specified in CTIS data.
- Biomarker Stratified
- True, MR-proANP (patients selected with MR-proANP level ≥200 pmol/L)
- Target Sample Size
- 400
- Trial Duration For Participant
- 365
Eligibility
Recruits 400 Vulnerable population selected for the trial (isVulnerablePopulationSelected = true). Written informed consent is required according to country-specific details. Subject information and informed consent forms are provided per country (documents listed for Spain and Greece). No explicit mention of assent or proxy consent procedures is provided in the CTIS data; age inclusion is ≥ 18 years..
- Pregnancy Exclusion
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission
- Vulnerable Population
- Vulnerable population selected for the trial (isVulnerablePopulationSelected = true). Written informed consent is required according to country-specific details. Subject information and informed consent forms are provided per country (documents listed for Spain and Greece). No explicit mention of assent or proxy consent procedures is provided in the CTIS data; age inclusion is ≥ 18 years.
Inclusion criteria
- {"criterion_text":"- MR-proANP level ≥200pmol/L within 72 hours from symptom onset\n- Age ≥ 18 years\n- Clinical diagnosis of ischemic stroke\n- Written informed consent according to country specific details"}
Exclusion criteria
- {"criterion_text":"- History of AF, AF on 12-lead ECG on admission or any AF ≥30 seconds during heart-rhythm monitoring prior to randomization\n- Other condition that require anticoagulant therapy (e.g., venous thromboembolism) as per Investigator’s judgment including therapeutic dose of low-molecularweight heparin or heparin\n- Strong likelihood to be treated with prolonged (i.e. more than 90 days) dual antiplatelet therapy during the course of the trial (such as coronary stenting, etc.)\n- Patients undergoing planned procedures where therapy with a DOAC is a contraindication (e.g. acute surgery)\n- Previous intracranial symptomatic hemorrhage in the last 24 months\n- Evidence of severe cerebral amyloid angiopathy if MRI scan performed\n- Chronic kidney disease with creatinine clearance <30ml/min and or subject who requires haemodialysis or peritoneal dialysis\n- Known bleeding diathesis (e.g. active peptic ulcer disease, platelet count < 100’000/mm3 or haemoglobin < 8 g/dl or INR ≥ 1.7, documented haemorrhagic tendencies or blood dyscrasias)\n- Active infective endocarditis\n- Known allergy or intolerance to antiplatelets or DOACs\n- Female who is pregnant or lactating or has a positive pregnancy test at time of admission\n- If restricted by national law: Current participation in another drug trial"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary outcome measure is the time to any recurrent stroke within 1 year after the index ischemic stroke.","definition_or_measurement_approach":"Time-to-event measure: time from index ischemic stroke to any recurrent stroke occurring within 1 year after the index event."}
Secondary endpoints
- {"endpoint_text":"- Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first) within 1 year after the index ischemic stroke; single components of the composite outcome above","definition_or_measurement_approach":"Composite time-to-event measure within 1 year after the index ischemic stroke; individual components (major bleeding, recurrent stroke, vascular death) also assessed."}
Recruitment
- Planned Sample Size
- 400
- Recruitment Window Months
- 55
- Consent Approach
- Written informed consent is required according to country-specific details. Subject information and informed consent forms are provided (documents for Spain and Greece listed). Consent is provided by the participant; no details on assent or proxy consent procedures are provided in the CTIS data. Age eligibility is ≥18 years.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 190
Spain
- Earliest CTIS Part Ii Submission Date
- 13-12-2024
- Latest Decision Or Authorization Date
- 17-01-2025
- Processing Time Days
- 35
- Number Of Sites
- 3
- Number Of Participants
- 150
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Unitat de Malalties Vasculars Cerebrals - Stroke Unit
- Contact Person Name
- Joan Martí-Fàbregas
- Contact Person Email
- jmartin@santpau.cat
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Neurology
- Contact Person Name
- Juan Antonio Cabezas Rodrigues
- Contact Person Email
- juancaro.jacr@gmail.com
- Site Name
- Hospital Universitario Virgen Macarena
- Department Name
- Neurology
- Contact Person Name
- Maria Reyes de Torres Chacón
- Contact Person Email
- reyesdetorreschacon@gmail.com
Greece
- Earliest CTIS Part Ii Submission Date
- 13-12-2024
- Latest Decision Or Authorization Date
- 23-01-2025
- Processing Time Days
- 41
- Number Of Sites
- 1
- Number Of Participants
- 40
Sites
- Site Name
- Attikon University Hospital
- Department Name
- Second Department of Neurology
- Contact Person Name
- Georgios Tsivgoulis
- Contact Person Email
- gtsivou@med.uoa.gr
Sponsor
Primary sponsor
- Full Name
- University Hospital Zurich
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Switzerland
Third parties
- {"country":"Greece","full_name":"Hellenic Institute for the Study of Sepsis","duties_or_roles":"codes: 12,14,5","organisation_type":"Health care"}
Investigational products
- Investigational Product Name
- Lixiana 30 mg film-coated tablets
- Active Substance
- Edoxaban
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 30 mg
- Dose Levels
- 30 mg
- Maximum Dose
- 30 mg
- Investigational Product Name
- Eliquis 2.5 mg film-coated tablets
- Active Substance
- Apixaban
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 2.5 mg
- Dose Levels
- 2.5 mg
- Maximum Dose
- 5 mg
- Investigational Product Name
- Lixiana 60 mg film-coated tablets
- Active Substance
- Edoxaban
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 60 mg
- Dose Levels
- 60 mg
- Maximum Dose
- 60 mg
- Investigational Product Name
- Pradaxa 150 mg hard capsules
- Active Substance
- Dabigatran etexilate
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 150 mg
- Dose Levels
- 150 mg
- Maximum Dose
- 300 mg
- Investigational Product Name
- Eliquis 5 mg film-coated tablets
- Active Substance
- Apixaban
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 5 mg
- Dose Levels
- 5 mg
- Maximum Dose
- 10 mg
- Investigational Product Name
- Pradaxa 110 mg hard capsules
- Active Substance
- Dabigatran etexilate
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 110 mg
- Dose Levels
- 110 mg
- Maximum Dose
- 220 mg
- Investigational Product Name
- Aspirine 100, 100 mg Tabletten
- Active Substance
- Acetylsalicylic acid
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 100 mg
- Dose Levels
- 100 mg
- Maximum Dose
- 100 mg
- Investigational Product Name
- Plavix 75 mg film-coated tablets
- Active Substance
- Clopidogrel
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Authorised
- Starting Dose
- 75 mg
- Dose Levels
- 75 mg
- Maximum Dose
- 75 mg
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