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
- Diseases
- Stroke, Atrial fibrillation
- 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
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Teaching Hospital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB) Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Department of Neurology, Martin-Luther-University of Halle-Wittenberg Coordinator of this site? Confirm its status | Halle | Germany | Recruiting |
| Copenhagen University Hospital, Bispebjerg Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Neurology Department, Assiut University Hospitals Coordinator of this site? Confirm its status | Asyut | Egypt | Recruiting |
| Neurology Department, Faculty of Medicine , Ain Shams University Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
| Neurology Unit, Kobry Elkoba Medical Complex Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
| La Paz University Hospital, Universidad Autónoma de Madrid, IdiPAZ Research Institute Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Department of Medicine, University of Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
| Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2 Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Southmead Hospital -North Bristol NHS Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| St. George's University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Department of Brain Sciences, Imperial College London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Department of Neurology, Sveti Duh University Hospital Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| Neurological Clinic, Marche Polytechnic University Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| SC Neurologia, Stroke Unit, Ospedale di Venere Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Irccs - Istituto Delle Scienze Neurologiche Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| SCA Neurologia, USL Umbria 1 Coordinator of this site? Confirm its status | Città di Castello | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
| SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Stroke Unit, Hospital Fabrizio Spazian Coordinator of this site? Confirm its status | Frosinone | Italy | Recruiting |
| University of L'Aquila Coordinator of this site? Confirm its status | L’Aquila | Italy | Recruiting |
| Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Neurology and Stroke Unit, AORN Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Department of Medicine and Surgery, University of Parma Coordinator of this site? Confirm its status | Parma | Italy | Recruiting |
| Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Medicina Interna e d'Urgenza - Stroke Unit, Azienda Ospedaliera di Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| Department of Emergency Neurology and Stroke Unit, Pescara Hospital Coordinator of this site? Confirm its status | Pescara | Italy | Recruiting |
| Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Recruiting |
| Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| UOSD Stroke Unit, Azienda Ospedaliera San Camillo Forlanini Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| UOC Neurologia, Ospedale Provinciale "Madonna del Soccorso" Coordinator of this site? Confirm its status | San Benedetto del Tronto | Italy | Recruiting |
| UOC Stroke Unit, Emergency and Urgency Department, AOU Senese Coordinator of this site? Confirm its status | Siena | Italy | Recruiting |
| ASL Abruzzo 4, G.Mazzini Hospital Coordinator of this site? Confirm its status | Teramo | Italy | Recruiting |
| SOSD Stroke Unit, Department of Head, Neck, and Neuroscience, Udine University Hospital Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| Stroke Unit, Neurologia A, Azienda Ospedaliera Universitaria Integrata di Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| University Clinic of Neurology, University "Ss.Cyril and Methodius"-Faculty of Medicine Coordinator of this site? Confirm its status | Skopje | North Macedonia | Recruiting |
| Department of Neurology, Jagiellonian University Medical College Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Lisbon Central University Hospital - ULS São José and Faculdade de Medicina, Universidade de Lisboa Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Hospital De Santa Maria Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Elias University Emergency Hospital, Carol Davila University of Medicine and Pharmacy Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| King Abdulaziz Medical City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Recruiting |
| Vascular Neurology Division National Neuroscience Institute King Fahad Medical City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Recruiting |
| Department of Neurology, Faculty of Medicine, P. J. Safarik University and University Hospital L. Pasteur Coordinator of this site? Confirm its status | Košice | Slovakia | Recruiting |
Related publications
- Competing Stroke Etiologies and Outcomes After Breakthrough Ischemic Stroke on Oral Anticoagulants in Patients With Atrial Fibrillation.Neurology · 2026 · PMID 41974022
- Impact of cancer on outcomes following breakthrough ischaemic stroke on oral anticoagulants for atrial fibrillation: insights from the ASPERA-R study.Eur Stroke J · 2026 · PMID 41758563
This page is information, not medical advice. Discuss any trial with your doctor.