Understanding Ischemic Stroke in Patients Taking Blood Thinners
Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants - The ASPERA International Registry
This study looks at how ischemic strokes affect people taking blood thinners for heart issues to see what helps prevent future strokes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of L'Aquila Academic / other |
| Locations | 47 sites (Zagreb and 46 other locations) |
| Trial ID | NCT06823466 on ClinicalTrials.gov |
What this trial studies
The ASPERA study investigates the characteristics and outcomes of ischemic stroke cases in patients who are on oral anticoagulation for atrial fibrillation or other cardioembolic arrhythmias. This multicenter, observational study collects both retrospective and prospective data from acute ischemic stroke patients worldwide. It aims to assess the short and long-term outcomes associated with various secondary prevention strategies to prevent stroke recurrences. The study is coordinated by the University of L'Aquila and involves multiple emergency services and stroke units.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced an ischemic stroke while on oral anticoagulation.
Not a fit: Patients who have not experienced an ischemic stroke or are not on oral anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing recurrent strokes in patients on anticoagulants.
How similar studies have performed: Other studies have explored similar topics, but the specific focus on ischemic stroke in patients on oral anticoagulation represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Zagreb and 46 other locations
- Department of Neurology, Sveti Duh University Hospital — Zagreb, Croatia (Recruiting)
- Copenhagen University Hospital, Bispebjerg Hospital — Copenhagen, Denmark (Recruiting)
- Neurology Department, Assiut University Hospitals — Asyut, Egypt (Recruiting)
- Neurology Department, Faculty of Medicine , Ain Shams University — Cairo, Egypt (Recruiting)
- Neurology Unit, Kobry Elkoba Medical Complex — Cairo, Egypt (Recruiting)
- Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2 — Nice, France (Recruiting)
- Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB) — Berlin, Germany (Recruiting)
- Department of Neurology, Martin-Luther-University of Halle-Wittenberg — Halle, Germany (Recruiting)
- Neurological Clinic, Marche Polytechnic University — Ancona, Italy (Recruiting)
- SC Neurologia, Stroke Unit, Ospedale di Venere — Bari, Italy (Recruiting)
- IRCCS Istituto delle Scienze Neurologiche — Bologna, Italy (Recruiting)
- SCA Neurologia, USL Umbria 1 — Città di Castello, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna — Ferrara, Italy (Recruiting)
- SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi — Florence, Italy (Recruiting)
- Stroke Unit, Hospital Fabrizio Spazian — Frosinone, Italy (Recruiting)
- University of L'Aquila — L’Aquila, Italy (Recruiting)
- Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (Recruiting)
- Neurology and Stroke Unit, AORN Antonio Cardarelli — Naples, Italy (Recruiting)
- UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello — Palermo, Italy (Recruiting)
- Department of Medicine and Surgery, University of Parma — Parma, Italy (Recruiting)
- Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino — Pavia, Italy (Recruiting)
- Medicina Interna e d'Urgenza - Stroke Unit, Azienda Ospedaliera di Perugia — Perugia, Italy (Recruiting)
- Department of Emergency Neurology and Stroke Unit, Pescara Hospital — Pescara, Italy (Recruiting)
- Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL Romagna — Ravenna, Italy (Recruiting)
- Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia — Reggio Emilia, Italy (Recruiting)
- UOSD Stroke Unit, Azienda Ospedaliera San Camillo Forlanini — Rome, Italy (Recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli — Rome, Italy (Recruiting)
- UOC Neurologia, Ospedale Provinciale "Madonna del Soccorso" — San Benedetto del Tronto, Italy (Recruiting)
- UOC Stroke Unit, Emergency and Urgency Department, AOU Senese — Siena, Italy (Recruiting)
- ASL Abruzzo 4, G.Mazzini Hospital — Teramo, Italy (Recruiting)
- SOSD Stroke Unit, Department of Head, Neck, and Neuroscience, Udine University Hospital — Udine, Italy (Recruiting)
- Stroke Unit, Neurologia A, Azienda Ospedaliera Universitaria Integrata di Verona — Verona, Italy (Recruiting)
- University Clinic of Neurology, University "Ss.Cyril and Methodius"-Faculty of Medicine — Skopje, North Macedonia (Recruiting)
- Department of Neurology, Jagiellonian University Medical College — Krakow, Poland (Recruiting)
- Lisbon Central University Hospital - ULS São José and Faculdade de Medicina, Universidade de Lisboa — Lisbon, Portugal (Recruiting)
- Hospital de Santa Maria — Lisbon, Portugal (Recruiting)
- Elias University Emergency Hospital, Carol Davila University of Medicine and Pharmacy — Bucharest, Romania (Recruiting)
- King Abdulaziz Medical City — Riyadh, Saudi Arabia (Recruiting)
- Vascular Neurology Division National Neuroscience Institute King Fahad Medical City — Riyadh, Saudi Arabia (Recruiting)
- Department of Neurology, Faculty of Medicine, P. J. Safarik University and University Hospital L. Pasteur — Košice, Slovakia (Recruiting)
- La Paz University Hospital, Universidad Autónoma de Madrid, IdiPAZ Research Institute — Madrid, Spain (Recruiting)
- Department of Medicine, University of Valladolid — Valladolid, Spain (Recruiting)
- University Teaching Hospital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
- Southmead Hospital, North Bristol NHS Trust — Bristol, UK, United Kingdom (Recruiting)
- St George's University Hospitals NHS Foundation Trust — London, UK, United Kingdom (Recruiting)
- Department of Brain Sciences, Imperial College London — London, UK, United Kingdom (Recruiting)
- Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College — London, UK, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Simona Sacco, MD
- Email: simona.sacco@univaq.it
- Phone: +39 0862433561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.