Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants
ASPERA
1 other identifier
observational
200
15 countries
47
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Longer than P75 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2025
CompletedFirst Posted
Study publicly available on registry
February 12, 2025
CompletedStudy Start
First participant enrolled
February 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 12, 2031
February 20, 2025
February 1, 2025
2 years
February 2, 2025
February 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
ASPERA-R Primary Outcome Measure: Baseline demographic characteristics
Baseline demographic characteristics of ischemic stroke cases occurring on oral anticoagulants: mean age (years), sex (proportion of males and females), ethnicity (proportion of non-Hispanic White, Hispanic White, Black, Asian, other ethnicities), mean weight (Kg), mean height (cm), median BMI
At the baseline (index ischemic stroke onset/hospital admission)
ASPERA-R Primary Outcome Measure: Baseline clinical characteristics
Baseline clinical characteristics: type of oral anticoagulation at the time of index ischemic stroke (proportion of patients on DOAC or VKA), ischemic stroke clinical severity (median National Insititue of Health Stroke Scale - NIHSS), type of clinical presentation (proportion of patients with anterior or posterior circulation stroke), competing stroke etiology (proportion of patients with large-artery-atherosclerosis or lacunar or other determined or undetermined etiology), risk factors (proportion of patients with hypertension, dyslipidemia, diabetes, history of prior stroke/transient ischemic attack, ischemic cardiopaty, peripheral artery disease, chronic kidney or liver failure), acute ischemic stroke treatment (proportion of patients who undergo intravenous thrombolysis or endovascular thrombectomy)
At the baseline (index ischemic stroke onset/hospital admission)
ASPERA-R Primary Outcome Measure: Baseline Neuroimaging characteristics
Baseline Neuroimaging characteristics: large vessel occlusion (proportion of patients with large vessel occlusion), site of large vessel occlusion (proportion of patients with anterior or middle or posterior cerebral arteries occlusion), degree of large vessel occlusion (according to the modified treatment in cerebral infarction - mTICI - score: from 0 - no perfusion - to 3 - complete perfusion), median number of new ischemic lesion(s) at neuroimaging, site of new ischemic lesion(s) at neuroimaging (anterior or posterior circulation, right or left hemisphere or bilateral), presence of hemorrhagic infarction at neuroimaging, degree of hemorrhagic infarction at neuroimaging (according to the Heidelberg classification system: Hemorrhagic Infarction - Small petechiae along the margins of the infarcted area or more confluent petechiae without space-occupying effect (HI2). Parenchymal Hematoma - A hematoma covering less (PH1) or more (PH2) than 30% of the infarcted area.
At the baseline (index ischemic stroke onset/hospital admission)
ASPERA-P Primary Outcome Measure: New ischemic stroke or transient ischemic attack
New ischemic stroke or transient ischemic attack (proportion of patients with new ischemic stroke or transient ischemic attack)
90-day, 1-year and 5-year post-stroke
Secondary Outcomes (15)
ASPERA-R Secondary Outcome Measure: All-cause mortality
Discharge and 90-day post-stroke
ASPERA-R Secondary Outcome Measure: Vascular death
Discharge and 90-day post-stroke
ASPERA-R Secondary Outcome Measure: New ischemic stroke or transient ischemic attack
Discharge and 90-day post-stroke
ASPERA-R Secondary Outcome Measure: Myocardial infarction
Discharge and 90-day post-stroke
ASPERA-R Secondary Outcome Measure: Moderate-to-severe bleeding events
Discharge and 90-day post-stroke
- +10 more secondary outcomes
Study Arms (2)
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
Eligibility Criteria
Patients will be enrolled from various recruiting sites worldwide. All consecutive ischemic stroke patients receiving oral anticoagulation therapy for atrial fibrillation or other cardioembolic arrhythmias at the time of the index stroke who meet the inclusion criteria will be eligible, regardless of hospitalization status. The decision to enroll a patient will be made by local investigators, who must ensure that each candidate meets the study's eligibility requirements.
You may qualify if:
- 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.
You may not qualify if:
- Symptoms not indicative of acute stroke (i.e., syncope, tonic or clonic activity, dizziness alone, confusion and amnesia alone, chronic or subacute development of focal neurological deficit).
- Ongoing parenteral (intravenous or subcutaneous) anticoagulation at the time of the index event, including bridging with heparin in patients initiating VKA.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Department of Neurology, Sveti Duh University Hospital
Zagreb, 10000, Croatia
Copenhagen University Hospital, Bispebjerg Hospital
Copenhagen, 2400, Denmark
Neurology Department, Assiut University Hospitals
Asyut, 71526, Egypt
Neurology Department, Faculty of Medicine , Ain Shams University
Cairo, 11566, Egypt
Neurology Unit, Kobry Elkoba Medical Complex
Cairo, 11799, Egypt
Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2
Nice, 06001, France
Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB)
Berlin, 10117, Germany
Department of Neurology, Martin-Luther-University of Halle-Wittenberg
Halle, 06112, Germany
Neurological Clinic, Marche Polytechnic University
Ancona, 60126, Italy
SC Neurologia, Stroke Unit, Ospedale di Venere
Bari, 70131, Italy
IRCCS Istituto delle Scienze Neurologiche
Bologna, 40139, Italy
SCA Neurologia, USL Umbria 1
Città di Castello, 06012, Italy
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna
Ferrara, Italy
SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
Stroke Unit, Hospital Fabrizio Spazian
Frosinone, 03100, Italy
University of L'Aquila
L’Aquila, 67100, Italy
Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Neurology and Stroke Unit, AORN Antonio Cardarelli
Naples, 80131, Italy
UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello
Palermo, Italy
Department of Medicine and Surgery, University of Parma
Parma, 43126, Italy
Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino
Pavia, 27100, Italy
Medicina Interna e d'Urgenza - Stroke Unit, Azienda Ospedaliera di Perugia
Perugia, 06132, Italy
Department of Emergency Neurology and Stroke Unit, Pescara Hospital
Pescara, 65124, Italy
Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL Romagna
Ravenna, 48124, Italy
Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
Reggio Emilia, 42123, Italy
UOSD Stroke Unit, Azienda Ospedaliera San Camillo Forlanini
Rome, 00152, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, 00168, Italy
UOC Neurologia, Ospedale Provinciale "Madonna del Soccorso"
San Benedetto del Tronto, 63074, Italy
UOC Stroke Unit, Emergency and Urgency Department, AOU Senese
Siena, 53100, Italy
ASL Abruzzo 4, G.Mazzini Hospital
Teramo, 64100, Italy
SOSD Stroke Unit, Department of Head, Neck, and Neuroscience, Udine University Hospital
Udine, 33100, Italy
Stroke Unit, Neurologia A, Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37126, Italy
University Clinic of Neurology, University "Ss.Cyril and Methodius"-Faculty of Medicine
Skopje, 1000, North Macedonia
Department of Neurology, Jagiellonian University Medical College
Krakow, 30-688, Poland
Lisbon Central University Hospital - ULS São José and Faculdade de Medicina, Universidade de Lisboa
Lisbon, 1649-028, Portugal
Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Elias University Emergency Hospital, Carol Davila University of Medicine and Pharmacy
Bucharest, 050474, Romania
King Abdulaziz Medical City
Riyadh, 11426, Saudi Arabia
Vascular Neurology Division National Neuroscience Institute King Fahad Medical City
Riyadh, 11525, Saudi Arabia
Department of Neurology, Faculty of Medicine, P. J. Safarik University and University Hospital L. Pasteur
Košice, 040 11, Slovakia
La Paz University Hospital, Universidad Autónoma de Madrid, IdiPAZ Research Institute
Madrid, 28046, Spain
Department of Medicine, University of Valladolid
Valladolid, 47005, Spain
University Teaching Hospital St. Gallen
Sankt Gallen, 9007, Switzerland
Southmead Hospital, North Bristol NHS Trust
Bristol, UK, BS10 5N, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, UK, SW17 0QT, United Kingdom
Department of Brain Sciences, Imperial College London
London, UK, W12 0NN, United Kingdom
Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College
London, UK, W6 8RF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 2, 2025
First Posted
February 12, 2025
Study Start
February 12, 2025
Primary Completion (Estimated)
February 12, 2027
Study Completion (Estimated)
February 12, 2031
Last Updated
February 20, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR, ANALYTIC CODE
- Time Frame
- From the end of the ASPERA-P study (10/02/2029) up to 10 years (10/02/2039)
- Access Criteria
- Access will be granted for purposes of replicating findings, conducting meta-analyses, or pursuing related research questions, subject to approval by the study's data governance committee and appropriate institutional review boards. Researchers will be required to sign data-sharing agreements to ensure proper use and compliance with confidentiality standards.
We plan to share individual clinical data collected in the study with other researchers upon reasonable request, in line with ethical guidelines and data protection regulations. Data will be de-identified to protect participant confidentiality.