Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants
NCT ID: NCT06823466
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-02-12
2031-02-12
Brief Summary
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ASPERA-P duration will be of 2 years of enrollment from the study approval and follow-up of 5 years. (study conclusion after 7 years of approval). Inclusion criteria will be: 1.Confirmed diagnosis of ischemic stroke. 2. Availability of at least one neuroimaging exam positive for ischemic lesion(s) consistent with patient symptoms. 3. Ongoing oral anticoagulation at the time of the index ischemic stroke. 4. Prior diagnosis of atrial fibrillation or other cardioembolic arrhythmias. 5. Written informed consent provided by the patient himself or by proxy. Patients with Symptoms not indicative of acute stroke, ongoing intravenous or subcutaneous anticoagulation at the time of stroke will be excluded. ASPERA-R: characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. The primary outcome will be: ASPERA-R : characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. ASPERA-P: risk of ischemic stroke recurrence of ischemic stroke cases occurring on oral anticoagulants across different secondary preventive strategies (i.e., maintaining the same type of oral anticoagulation versus switching to a different secondary prevention strategy) at 90 days, 1 and 5 years after the index stroke. Additionally, the study will aim to investigate the risk of safety events (hemorrhagic transformation, intracranial hemorrhage, other major bleeding events, any bleeding events, death due to any cause), risk of other major ischemic events (transient ischemic attack, myocardial infarction, death due to vascular causes) at each follow-up and to identify demographic, clinical and neuroimaging features of ischemic stroke recurrences.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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ASPERA-R
Retrospectively enrolled schemic stroke patients on oral anticoagulants at the time of the index stroke followed up at hospital discharge and 90 days post-stroke
No interventions assigned to this group
ASPERA-P
Prospectively enrolled ischemic stroke patients on oral anticoagulants at the time of the index stroke followed up at 90 days, 1 year and 5 years post-stroke
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of ischemic stroke according to the World Health Organization (WHO) definition.
* Availability of at least one neuroimaging exam (either a non-contrast computed tomography \[NCCT\] or magnetic resonance imaging \[MRI\] of the brain) demonstrating one or more ischemic lesions consistent with patient symptoms.
* Ongoing oral anticoagulation at the time of the index ischemic stroke, defined as the last intake within 48 hours prior to stroke symptom onset for patients on direct oral anticoagulants (DOACs), or an international normalized ratio (INR) of ≥1.5 in patients on vitamin K antagonists (VKAs), regardless of the time elapsed between the last intake and stroke symptom onset.
* Prior diagnosis of AF or other cardioembolic arrhythmias.
Exclusion Criteria
* Ongoing parenteral (intravenous or subcutaneous) anticoagulation at the time of the index event, including bridging with heparin in patients initiating VKA.
18 Years
ALL
No
Sponsors
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University of L'Aquila
OTHER
Responsible Party
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Simona Sacco
Professor
Locations
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Department of Neurology, Sveti Duh University Hospital
Zagreb, , Croatia
Copenhagen University Hospital, Bispebjerg Hospital
Copenhagen, , Denmark
Neurology Department, Assiut University Hospitals
Asyut, , Egypt
Neurology Department, Faculty of Medicine , Ain Shams University
Cairo, , Egypt
Neurology Unit, Kobry Elkoba Medical Complex
Cairo, , Egypt
Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2
Nice, , France
Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB)
Berlin, , Germany
Department of Neurology, Martin-Luther-University of Halle-Wittenberg
Halle, , Germany
Neurological Clinic, Marche Polytechnic University
Ancona, , Italy
SC Neurologia, Stroke Unit, Ospedale di Venere
Bari, , Italy
IRCCS Istituto delle Scienze Neurologiche
Bologna, , Italy
SCA Neurologia, USL Umbria 1
Città di Castello, , Italy
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna
Ferrara, , Italy
SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Stroke Unit, Hospital Fabrizio Spazian
Frosinone, , Italy
University of L'Aquila
L’Aquila, , Italy
Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Neurology and Stroke Unit, AORN Antonio Cardarelli
Naples, , Italy
UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello
Palermo, , Italy
Department of Medicine and Surgery, University of Parma
Parma, , Italy
Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino
Pavia, , Italy
Medicina Interna e d'Urgenza - Stroke Unit, Azienda Ospedaliera di Perugia
Perugia, , Italy
Department of Emergency Neurology and Stroke Unit, Pescara Hospital
Pescara, , Italy
Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL Romagna
Ravenna, , Italy
Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
Reggio Emilia, , Italy
UOSD Stroke Unit, Azienda Ospedaliera San Camillo Forlanini
Rome, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, , Italy
UOC Neurologia, Ospedale Provinciale "Madonna del Soccorso"
San Benedetto del Tronto, , Italy
UOC Stroke Unit, Emergency and Urgency Department, AOU Senese
Siena, , Italy
ASL Abruzzo 4, G.Mazzini Hospital
Teramo, , Italy
SOSD Stroke Unit, Department of Head, Neck, and Neuroscience, Udine University Hospital
Udine, , Italy
Stroke Unit, Neurologia A, Azienda Ospedaliera Universitaria Integrata di Verona
Verona, , Italy
University Clinic of Neurology, University "Ss.Cyril and Methodius"-Faculty of Medicine
Skopje, , North Macedonia
Department of Neurology, Jagiellonian University Medical College
Krakow, , Poland
Lisbon Central University Hospital - ULS São José and Faculdade de Medicina, Universidade de Lisboa
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Elias University Emergency Hospital, Carol Davila University of Medicine and Pharmacy
Bucharest, , Romania
King Abdulaziz Medical City
Riyadh, , Saudi Arabia
Vascular Neurology Division National Neuroscience Institute King Fahad Medical City
Riyadh, , Saudi Arabia
Department of Neurology, Faculty of Medicine, P. J. Safarik University and University Hospital L. Pasteur
Košice, , Slovakia
La Paz University Hospital, Universidad Autónoma de Madrid, IdiPAZ Research Institute
Madrid, , Spain
Department of Medicine, University of Valladolid
Valladolid, , Spain
University Teaching Hospital St. Gallen
Sankt Gallen, , Switzerland
Southmead Hospital, North Bristol NHS Trust
Bristol, UK, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, UK, United Kingdom
Department of Brain Sciences, Imperial College London
London, UK, United Kingdom
Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College
London, UK, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2696 - 22/07/2024
Identifier Type: -
Identifier Source: org_study_id
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