Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants

Recruiting now

Conditions studied: Ischemic Stroke, Oral Anticoagulation, Atrial Fibrillation (AF), Outcome Assessment, Clinical Presentations

In brief

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.

Key facts

Study ID

NCT06823466

Run by

University of L'Aquila

People needed

200

Starts

2025-02-12

Expected to finish

2031-02-12

Last updated by the study team

2025-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Department of Neurology, Sveti Duh University Hospital — Zagreb, Croatia (enrolling)
• Copenhagen University Hospital, Bispebjerg Hospital — Copenhagen, Denmark (enrolling)
• Neurology Department, Assiut University Hospitals — Asyut, Egypt (enrolling)
• Neurology Department, Faculty of Medicine , Ain Shams University — Cairo, Egypt (enrolling)
• Neurology Unit, Kobry Elkoba Medical Complex — Cairo, Egypt (enrolling)
• Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2 — Nice, France (enrolling)
• Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB) — Berlin, Germany (enrolling)
• Department of Neurology, Martin-Luther-University of Halle-Wittenberg — Halle, Germany (enrolling)
• Neurological Clinic, Marche Polytechnic University — Ancona, Italy (enrolling)
• SC Neurologia, Stroke Unit, Ospedale di Venere — Bari, Italy (enrolling)
• IRCCS Istituto delle Scienze Neurologiche — Bologna, Italy (enrolling)
• SCA Neurologia, USL Umbria 1 — Città di Castello, Italy (enrolling)
• Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna — Ferrara, Italy (enrolling)
• SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi — Florence, Italy (enrolling)
• Stroke Unit, Hospital Fabrizio Spazian — Frosinone, Italy (enrolling)
• University of L'Aquila — L’Aquila, Italy (enrolling)
• Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (enrolling)
• Neurology and Stroke Unit, AORN Antonio Cardarelli — Naples, Italy (enrolling)
• UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello — Palermo, Italy (enrolling)
• Department of Medicine and Surgery, University of Parma — Parma, Italy (enrolling)
• Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino — Pavia, Italy (enrolling)
• Medicina Interna e d'Urgenza - Stroke Unit, Azienda Ospedaliera di Perugia — Perugia, Italy (enrolling)
• Department of Emergency Neurology and Stroke Unit, Pescara Hospital — Pescara, Italy (enrolling)
• Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL Romagna — Ravenna, Italy (enrolling)
• Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia — Reggio Emilia, Italy (enrolling)

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