Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants

Официальное название

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

Обзор

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.

Первичные конечные точки

• ASPERA-R Primary Outcome Measure: Baseline demographic characteristics [Срок оценки: At the baseline (index ischemic stroke onset/hospital admission)]
• ASPERA-R Primary Outcome Measure: Baseline clinical characteristics [Срок оценки: At the baseline (index ischemic stroke onset/hospital admission)]
• ASPERA-R Primary Outcome Measure: Baseline Neuroimaging characteristics [Срок оценки: At the baseline (index ischemic stroke onset/hospital admission)]
• ASPERA-P Primary Outcome Measure: New ischemic stroke or transient ischemic attack [Срок оценки: 90-day, 1-year and 5-year post-stroke]

Вторичные конечные точки (12)

• ASPERA-R Secondary Outcome Measure: All-cause mortality [Срок оценки: Discharge and 90-day post-stroke]
• ASPERA-R Secondary Outcome Measure: Vascular death [Срок оценки: Discharge and 90-day post-stroke]
• ASPERA-R Secondary Outcome Measure: New ischemic stroke or transient ischemic attack [Срок оценки: Discharge and 90-day post-stroke]
• ASPERA-R Secondary Outcome Measure: Myocardial infarction [Срок оценки: Discharge and 90-day post-stroke]
• ASPERA-R Secondary Outcome Measure: Moderate-to-severe bleeding events [Срок оценки: Discharge and 90-day post-stroke]
• ASPERA-R Secondary Outcome Measure: Intracranial hemorrhage [Срок оценки: Discharge and 90-day post-stroke]
• ASPERA-R Secondary Outcome Measure: Ordinal distribution of modified Rankin Scale scores [Срок оценки: Discharge and 90-day post-stroke]
• ASPERA-P Secondary Outcome Measure: All-cause mortality [Срок оценки: 90-day, 1-year and 5-year post-stroke]
• ASPERA-P Secondary Outcome Measure: Vascular death [Срок оценки: 90-day, 1-year and 5-year post-stroke]
• ASPERA-P Secondary Outcome Measure: Myocardial infarction [Срок оценки: 90-day, 1-year and 5-year post-stroke]
• ASPERA-P Secondary Outcome Measure: Intracranial Hemorrhage [Срок оценки: 90-day, 1-year and 5-year post-stroke]
• ASPERA-P Secondary Outcome Measure: Moderate-to-severe bleeding events [Срок оценки: 90-day, 1-year and 5-year post-stroke]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 24 центра

• Neurological Clinic, Marche Polytechnic University — Ancona
• SC Neurologia, Stroke Unit, Ospedale di Venere — Bari
• IRCCS Istituto delle Scienze Neurologiche — Bologna
• SCA Neurologia, USL Umbria 1 — Città di Castello
• Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna — Ferrara
• SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi — Florence
• Stroke Unit, Hospital Fabrizio Spazian — Frosinone
• University of L'Aquila — L’Aquila
• … и ещё 16 центров

Великобритания · 4 центра

• Southmead Hospital, North Bristol NHS Trust — Bristol
• St George's University Hospitals NHS Foundation Trust — London
• Department of Brain Sciences, Imperial College London — London
• Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College — London

Египет · 3 центра

• Neurology Department, Assiut University Hospitals — Asyut
• Neurology Department, Faculty of Medicine , Ain Shams University — Cairo
• Neurology Unit, Kobry Elkoba Medical Complex — Cairo

Германия · 2 центра

• Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB) — Berlin
• Department of Neurology, Martin-Luther-University of Halle-Wittenberg — Halle

Португалия · 2 центра

• Lisbon Central University Hospital - ULS São José and Faculdade de Medicina, Universidade — Lisbon
• Hospital de Santa Maria — Lisbon

Саудовская Аравия · 2 центра

• King Abdulaziz Medical City — Riyadh
• Vascular Neurology Division National Neuroscience Institute King Fahad Medical City — Riyadh

Испания · 2 центра

• La Paz University Hospital, Universidad Autónoma de Madrid, IdiPAZ Research Institute — Madrid
• Department of Medicine, University of Valladolid — Valladolid

Хорватия · 1 центр

• Department of Neurology, Sveti Duh University Hospital — Zagreb

Дания · 1 центр

• Copenhagen University Hospital, Bispebjerg Hospital — Copenhagen

Франция · 1 центр

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

North Macedonia · 1 центр

• University Clinic of Neurology, University "Ss.Cyril and Methodius"-Faculty of Medicine — Skopje

Польша · 1 центр

• Department of Neurology, Jagiellonian University Medical College — Krakow

Румыния · 1 центр

• Elias University Emergency Hospital, Carol Davila University of Medicine and Pharmacy — Bucharest

Словакия · 1 центр

• Department of Neurology, Faculty of Medicine, P. J. Safarik University and University Hosp — Košice

Швейцария · 1 центр

• University Teaching Hospital St. Gallen — Sankt Gallen

Публикации

• Foschi M, De Santis F, Gabriele F, Ornello R, D'Anna L, Zini A, Paolucci M, Forlivesi S, Migliaccio L, Viola MM, Cascio Rizzo A, Sessa M, Schwarz G, Tortorella R, Banerjee S, Desai G, Ahmed KF, Prandin G, Pantoni L, Mele F, Scopelliti G, Cova I, Valente M, Maisano D, Antonelli L, Bagnato MR, Di Mauro G, Bernocchi F, Di Donna MG, Casolla B, Mazloum P, Campisi C, Caraux A, Gonzalez-Martin L, Rigual PMID 41974022
• Foschi M, De Santis F, Gabriele F, D'Anna L, Zini A, Paolucci M, Forlivesi S, Migliaccio L, Viola MM, Rizzo AC, Sessa M, Schwarz G, Tortorella R, Banerjee S, Desai G, Jaffar M, Prandin G, Pantoni L, Mele F, Scopelliti G, Cova I, Valente M, Maisano D, Antonelli L, Bagnato MR, Di Mauro G, Bernocchi F, Di Donna MG, Casolla B, Mazloum MP, Kacani K, Djeghlal NA, Gonzalez-Martin L, Rigual R, Fuentes B, PMID 41758563

Идентификаторы

NCT: NCT06823466 · 2696 - 22/07/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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