Competing Stroke Etiologies and Outcomes After Breakthrough Ischemic Stroke on Oral Anticoagulants in Patients With Atrial Fibrillation.
Matteo Foschi, Federico De Santis, Francesca Gabriele...
https://pubmed.ncbi.nlm.nih.gov/41974022Actively Recruiting
Age: 18Years +
All Genders
ID06823466
Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants - The ASPERA International Registry
Led by University of L'Aquila · Updated on 2025-02-20
200
Participants Needed
47
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating ischemic stroke cases in patients who are on oral anticoagulants due to atrial fibrillation or other cardioembolic arrhythmias. This observational study, called ASPERA, aims to understand the characteristics of these stroke cases and to evaluate the short- and long-term outcomes of different strategies used to prevent recurrent strokes. The study includes both retrospective and prospective data collection from multiple centers worldwide, coordinated by the University of L'Aquila. The study has two parts: ASPERA-R and ASPERA-P. ASPERA-R collects retrospective data over five years, focusing on baseline demographic, clinical, and neuroimaging features of ischemic strokes in patients on oral anticoagulants. ASPERA-P enrolls patients prospectively for two years with follow-up for five years to assess risks of stroke recurrence and safety events under different secondary prevention approaches, such as continuing or changing oral anticoagulation. Participants will have their data collected at several time points, including hospital admission, discharge, and follow-ups at 90 days, 1 year, and 5 years after stroke. Assessments include clinical evaluations, neuroimaging exams, and monitoring for stroke recurrence, bleeding events, heart attacks, and mortality. The study tracks outcomes to better understand risks and to identify features linked to stroke recurrence and safety events, with total participation lasting up to seven years for prospective patients.
CONDITIONS
Brief Title
Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of the index ischemic stroke
- Confirmed diagnosis of ischemic stroke according to WHO definition
- At least one brain imaging exam showing ischemic lesions matching symptoms
- Taking oral anticoagulants at the time of stroke (last dose within 48 hours for DOACs or INR ≥1.5 for VKAs)
- Prior diagnosis of atrial fibrillation or other cardioembolic arrhythmias
- Written informed consent provided by patient or proxy
You will not qualify if you...
- Symptoms not indicating acute stroke (such as syncope, seizures, dizziness alone, confusion alone, or slowly developing neurological deficits)
- Receiving intravenous or subcutaneous anticoagulation at the time of stroke, including heparin bridging when starting VKAs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surveillance
Duration - Up to 5 years post-stroke
Participants who had an ischemic stroke while on oral anticoagulants are observed for health outcomes including new strokes, bleeding events, and mortality.
Visits at hospital discharge, 90 days, 1 year, and 5 years post-stroke depending on cohort
Trial Site Locations
Total: 47 locations
1
Department of Neurology, Sveti Duh University Hospital
Zagreb, Croatia, 10000
Actively Recruiting
2
Copenhagen University Hospital, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Actively Recruiting
3
Neurology Department, Assiut University Hospitals
Asyut, Egypt, 71526
Actively Recruiting
4
Neurology Department, Faculty of Medicine , Ain Shams University
Cairo, Egypt, 11566
Actively Recruiting
5
Neurology Unit, Kobry Elkoba Medical Complex
Cairo, Egypt, 11799
Actively Recruiting
6
Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2
Nice, France, 06001
Actively Recruiting
7
Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB)
Berlin, Germany, 10117
Actively Recruiting
8
Department of Neurology, Martin-Luther-University of Halle-Wittenberg
Halle, Germany, 06112
Actively Recruiting
9
Neurological Clinic, Marche Polytechnic University
Ancona, Italy, 60126
Actively Recruiting
10
SC Neurologia, Stroke Unit, Ospedale di Venere
Bari, Italy, 70131
Actively Recruiting
11
IRCCS Istituto delle Scienze Neurologiche
Bologna, Italy, 40139
Actively Recruiting
12
SCA Neurologia, USL Umbria 1
Città di Castello, Italy, 06012
Actively Recruiting
13
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna
Ferrara, Italy
Actively Recruiting
14
SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
15
Stroke Unit, Hospital Fabrizio Spazian
Frosinone, Italy, 03100
Actively Recruiting
16
University of L'Aquila
L’Aquila, Italy, 67100
Actively Recruiting
17
Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
18
Neurology and Stroke Unit, AORN Antonio Cardarelli
Naples, Italy, 80131
Actively Recruiting
19
UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello
Palermo, Italy
Actively Recruiting
20
Department of Medicine and Surgery, University of Parma
Parma, Italy, 43126
Actively Recruiting
21
Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino
Pavia, Italy, 27100
Actively Recruiting
22
Medicina Interna e d'Urgenza - Stroke Unit, Azienda Ospedaliera di Perugia
Perugia, Italy, 06132
Actively Recruiting
23
Department of Emergency Neurology and Stroke Unit, Pescara Hospital
Pescara, Italy, 65124
Actively Recruiting
24
Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL Romagna
Ravenna, Italy, 48124
Actively Recruiting
25
Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
Reggio Emilia, Italy, 42123
Actively Recruiting
26
UOSD Stroke Unit, Azienda Ospedaliera San Camillo Forlanini
Rome, Italy, 00152
Actively Recruiting
27
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy, 00168
Actively Recruiting
28
UOC Neurologia, Ospedale Provinciale "Madonna del Soccorso"
San Benedetto del Tronto, Italy, 63074
Actively Recruiting
29
UOC Stroke Unit, Emergency and Urgency Department, AOU Senese
Siena, Italy, 53100
Actively Recruiting
30
ASL Abruzzo 4, G.Mazzini Hospital
Teramo, Italy, 64100
Actively Recruiting
31
SOSD Stroke Unit, Department of Head, Neck, and Neuroscience, Udine University Hospital
Udine, Italy, 33100
Actively Recruiting
32
Stroke Unit, Neurologia A, Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy, 37126
Actively Recruiting
33
University Clinic of Neurology, University "Ss.Cyril and Methodius"-Faculty of Medicine
Skopje, North Macedonia, 1000
Actively Recruiting
34
Department of Neurology, Jagiellonian University Medical College
Krakow, Poland, 30-688
Actively Recruiting
35
Lisbon Central University Hospital - ULS São José and Faculdade de Medicina, Universidade de Lisboa
Lisbon, Portugal, 1649-028
Actively Recruiting
36
Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
37
Elias University Emergency Hospital, Carol Davila University of Medicine and Pharmacy
Bucharest, Romania, 050474
Actively Recruiting
38
King Abdulaziz Medical City
Riyadh, Saudi Arabia, 11426
Actively Recruiting
39
Vascular Neurology Division National Neuroscience Institute King Fahad Medical City
Riyadh, Saudi Arabia, 11525
Actively Recruiting
40
Department of Neurology, Faculty of Medicine, P. J. Safarik University and University Hospital L. Pasteur
Košice, Slovakia, 040 11
Actively Recruiting
41
La Paz University Hospital, Universidad Autónoma de Madrid, IdiPAZ Research Institute
Madrid, Spain, 28046
Actively Recruiting
42
Department of Medicine, University of Valladolid
Valladolid, Spain, 47005
Actively Recruiting
43
University Teaching Hospital St. Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
44
Southmead Hospital, North Bristol NHS Trust
Bristol, UK, United Kingdom, BS10 5N
Actively Recruiting
45
St George's University Hospitals NHS Foundation Trust
London, UK, United Kingdom, SW17 0QT
Actively Recruiting
46
Department of Brain Sciences, Imperial College London
London, UK, United Kingdom, W12 0NN
Actively Recruiting
47
Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College
London, UK, United Kingdom, W6 8RF
Actively Recruiting
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Research Team
S
Simona Sacco, MD
M
Matteo Foschi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Impact of cancer on outcomes following breakthrough ischaemic stroke on oral anticoagulants for atrial fibrillation: insights from the ASPERA-R study.
Matteo Foschi, Federico De Santis, Francesca Gabriele...
https://pubmed.ncbi.nlm.nih.gov/41758563