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NCT06823466Recruiting

Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants

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

Source: ClinicalTrials.gov · Last updated 20 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
2 Feb 2025
Start date
12 Feb 2025
Primary completion date
12 Feb 2027
Lead sponsor
University of L'Aquila
NCT number
NCT06823466

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 12 Feb 2025 to the primary completion date, 12 Feb 2027
  • 47 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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).

Other

  • Ongoing parenteral (intravenous or subcutaneous) anticoagulation at the time of the index event, including bridging with heparin in patients initiating VKA.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Teaching Hospital St. Gallen
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Sankt GallenSwitzerlandRecruiting
Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB)
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BerlinGermanyRecruiting
Department of Neurology, Martin-Luther-University of Halle-Wittenberg
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HalleGermanyRecruiting
Copenhagen University Hospital, Bispebjerg Hospital
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CopenhagenDenmarkRecruiting
Neurology Department, Assiut University Hospitals
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AsyutEgyptRecruiting
Neurology Department, Faculty of Medicine , Ain Shams University
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CairoEgyptRecruiting
Neurology Unit, Kobry Elkoba Medical Complex
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CairoEgyptRecruiting
La Paz University Hospital, Universidad Autónoma de Madrid, IdiPAZ Research Institute
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MadridSpainRecruiting
Department of Medicine, University of Valladolid
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ValladolidSpainRecruiting
Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2
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NiceFranceRecruiting
Southmead Hospital -North Bristol NHS Trust
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BristolUnited KingdomRecruiting
St. George's University Hospitals NHS Foundation Trust
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LondonUnited KingdomRecruiting
Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College
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LondonUnited KingdomRecruiting
Department of Brain Sciences, Imperial College London
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LondonUnited KingdomRecruiting
Department of Neurology, Sveti Duh University Hospital
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ZagrebCroatiaRecruiting
Neurological Clinic, Marche Polytechnic University
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AnconaItalyRecruiting
SC Neurologia, Stroke Unit, Ospedale di Venere
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BariItalyRecruiting
Irccs - Istituto Delle Scienze Neurologiche
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BolognaItalyRecruiting
SCA Neurologia, USL Umbria 1
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Città di CastelloItalyRecruiting
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
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FerraraItalyRecruiting
SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi
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FlorenceItalyRecruiting
Stroke Unit, Hospital Fabrizio Spazian
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FrosinoneItalyRecruiting
University of L'Aquila
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L’AquilaItalyRecruiting
Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Neurology and Stroke Unit, AORN Antonio Cardarelli
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NaplesItalyRecruiting
UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello
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PalermoItalyRecruiting
Department of Medicine and Surgery, University of Parma
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ParmaItalyRecruiting
Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino
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PaviaItalyRecruiting
Medicina Interna e d'Urgenza - Stroke Unit, Azienda Ospedaliera di Perugia
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PerugiaItalyRecruiting
Department of Emergency Neurology and Stroke Unit, Pescara Hospital
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PescaraItalyRecruiting
Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL Romagna
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RavennaItalyRecruiting
Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
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Reggio EmiliaItalyRecruiting
UOSD Stroke Unit, Azienda Ospedaliera San Camillo Forlanini
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli
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RomeItalyRecruiting
UOC Neurologia, Ospedale Provinciale "Madonna del Soccorso"
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San Benedetto del TrontoItalyRecruiting
UOC Stroke Unit, Emergency and Urgency Department, AOU Senese
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SienaItalyRecruiting
ASL Abruzzo 4, G.Mazzini Hospital
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TeramoItalyRecruiting
SOSD Stroke Unit, Department of Head, Neck, and Neuroscience, Udine University Hospital
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UdineItalyRecruiting
Stroke Unit, Neurologia A, Azienda Ospedaliera Universitaria Integrata di Verona
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VeronaItalyRecruiting
University Clinic of Neurology, University "Ss.Cyril and Methodius"-Faculty of Medicine
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SkopjeNorth MacedoniaRecruiting
Department of Neurology, Jagiellonian University Medical College
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KrakowPolandRecruiting
Lisbon Central University Hospital - ULS São José and Faculdade de Medicina, Universidade de Lisboa
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LisbonPortugalRecruiting
Hospital De Santa Maria
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LisbonPortugalRecruiting
Elias University Emergency Hospital, Carol Davila University of Medicine and Pharmacy
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BucharestRomaniaRecruiting
King Abdulaziz Medical City
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RiyadhSaudi ArabiaRecruiting
Vascular Neurology Division National Neuroscience Institute King Fahad Medical City
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RiyadhSaudi ArabiaRecruiting
Department of Neurology, Faculty of Medicine, P. J. Safarik University and University Hospital L. Pasteur
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KošiceSlovakiaRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.