Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants - The ASPERA International Registry

Status: Recruiting
Location: See all (46) locations...
Study Type: Observational
SUMMARY

The Advancing knowledge in ischemic Stroke PatiEnts on oRal Anticoagulants (ASPERA) study aims to investigate characteristics of ischemic stroke cases occurring in patients on oral anticoagulation for atrial fibrillation (AF) or other cardioembolic arrhythmias and to characterize short and long-term outcomes associated with different secondary prevention strategies to prevent stroke recurrences. The ASPERA study is a multicenter, observational, both retrospective and prospective real-world study involving acute ischemic stroke patients occurring on oral anticoagulation. The study will encompass a retrospective (ASPERA-R) and prospective (ASPERA-P) data collection. Patient will be recruited consecutively at different emergency services and stroke units worldwide. University of L'Aquila (UnivAQ) will be in charge of study coordination, data analysis and management. The duration of ASPERA-R will be of 5-year from the study initiation of the study. Participating centers will be given a 6-month timeframe to enter retrospective data, commencing from the date of study approval. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years at the time of the index ischemic stroke.

• 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.

Locations
Other Locations
Croatia
Department of Neurology, Sveti Duh University Hospital
RECRUITING
Zagreb
Denmark
Copenhagen University Hospital, Bispebjerg Hospital
RECRUITING
Copenhagen
Egypt
Neurology Department, Assiut University Hospitals
RECRUITING
Asyut
Neurology Department, Faculty of Medicine , Ain Shams University
RECRUITING
Cairo
Neurology Unit, Kobry Elkoba Medical Complex
RECRUITING
Cairo
France
Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2
RECRUITING
Nice
Germany
Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB)
RECRUITING
Berlin
Department of Neurology, Martin-Luther-University of Halle-Wittenberg
RECRUITING
Halle
Italy
Neurological Clinic, Marche Polytechnic University
RECRUITING
Ancona
SC Neurologia, Stroke Unit, Ospedale di Venere
RECRUITING
Bari
IRCCS Istituto delle Scienze Neurologiche
RECRUITING
Bologna
SCA Neurologia, USL Umbria 1
RECRUITING
Città Di Castello
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna
RECRUITING
Ferrara
SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi
RECRUITING
Florence
Stroke Unit, Hospital Fabrizio Spazian
RECRUITING
Frosinone
University of L'Aquila
RECRUITING
L’aquila
Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Neurology and Stroke Unit, AORN Antonio Cardarelli
RECRUITING
Naples
UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello
RECRUITING
Palermo
Department of Medicine and Surgery, University of Parma
RECRUITING
Parma
Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino
RECRUITING
Pavia
Medicina Interna e d'Urgenza - Stroke Unit, Azienda Ospedaliera di Perugia
RECRUITING
Perugia
Department of Emergency Neurology and Stroke Unit, Pescara Hospital
RECRUITING
Pescara
Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL Romagna
RECRUITING
Ravenna
Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
RECRUITING
Reggio Emilia
Fondazione Policlinico Universitario Agostino Gemelli
RECRUITING
Rome
UOSD Stroke Unit, Azienda Ospedaliera San Camillo Forlanini
RECRUITING
Rome
UOC Neurologia, Ospedale Provinciale Madonna del Soccorso
RECRUITING
San Benedetto Del Tronto
UOC Stroke Unit, Emergency and Urgency Department, AOU Senese
RECRUITING
Siena
ASL Abruzzo 4, G.Mazzini Hospital
RECRUITING
Teramo
SOSD Stroke Unit, Department of Head, Neck, and Neuroscience, Udine University Hospital
RECRUITING
Udine
Stroke Unit, Neurologia A, Azienda Ospedaliera Universitaria Integrata di Verona
RECRUITING
Verona
Poland
Department of Neurology, Jagiellonian University Medical College
RECRUITING
Krakow
Portugal
Hospital de Santa Maria
RECRUITING
Lisbon
Lisbon Central University Hospital - ULS São José and Faculdade de Medicina, Universidade de Lisboa
RECRUITING
Lisbon
Romania
Elias University Emergency Hospital, Carol Davila University of Medicine and Pharmacy
RECRUITING
Bucharest
Saudi Arabia
King Abdulaziz Medical City
RECRUITING
Riyadh
Vascular Neurology Division National Neuroscience Institute King Fahad Medical City
RECRUITING
Riyadh
Slovakia
Department of Neurology, Faculty of Medicine, P. J. Safarik University and University Hospital L. Pasteur
RECRUITING
Košice
Spain
La Paz University Hospital, Universidad Autónoma de Madrid, IdiPAZ Research Institute
RECRUITING
Madrid
Department of Medicine, University of Valladolid
RECRUITING
Valladolid
Switzerland
University Teaching Hospital St. Gallen
RECRUITING
Sankt Gallen
United Kingdom
Southmead Hospital, North Bristol NHS Trust
RECRUITING
Bristol
Department of Brain Sciences, Imperial College London
RECRUITING
London
Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College
RECRUITING
London
St George's University Hospitals NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Simona Sacco, MD
simona.sacco@univaq.it
+39 0862433561
Backup
Matteo Foschi, MD
matteo.foschi@graduate.univaq.it
+39 3478929126
Time Frame
Start Date: 2025-02-12
Estimated Completion Date: 2031-02-12
Participants
Target number of participants: 200
Treatments
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
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
Sponsors
Leads: University of L'Aquila

This content was sourced from clinicaltrials.gov