RECRUITINGOBSERVATIONAL

Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Locations (20)

Department of Neurology, Sveti Duh University Hospital

Zagreb, Croatia

Copenhagen University Hospital, Bispebjerg Hospital

Copenhagen, Denmark

Neurology Department, Assiut University Hospitals

Asyut, Egypt

Neurology Department, Faculty of Medicine , Ain Shams University

Cairo, Egypt

Neurology Unit, Kobry Elkoba Medical Complex

Cairo, Egypt

Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2

Nice, France

Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB)

Berlin, Germany

Department of Neurology, Martin-Luther-University of Halle-Wittenberg

Halle, Germany

Neurological Clinic, Marche Polytechnic University

Ancona, Italy

SC Neurologia, Stroke Unit, Ospedale di Venere

Bari, Italy

IRCCS Istituto delle Scienze Neurologiche

Bologna, Italy

SCA Neurologia, USL Umbria 1

Città di Castello, Italy

Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna

Ferrara, Italy

SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Stroke Unit, Hospital Fabrizio Spazian

Frosinone, Italy

University of L'Aquila

L’Aquila, Italy

Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Neurology and Stroke Unit, AORN Antonio Cardarelli

Naples, Italy

UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello

Palermo, Italy

Department of Medicine and Surgery, University of Parma

Parma, Italy