Clinical trial NCT06823466: Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants
Official title: Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants - The ASPERA International Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Oral Anticoagulation
Atrial Fibrillation (AF)
Outcome Assessment
Clinical Presentations
Keywords: Ischemic stroke
Oral anticoagulation
Atrial fibrillation
Direct oral anticoagulants
Vitamin k antagonists
Outcomes
Prognosis
Clinical characteristics
Secondary prevention
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled from various recruiting sites worldwide. All consecutive ischemic stroke patients receiving oral anticoagulation therapy for atrial fibrillation or other cardioembolic arrhythmias at the time of the index stroke who meet the inclusion criteria will be eligible, regardless of hospitalization status. The decision to enroll a patient will be made by local investigators, who must ensure that each candidate meets the study's eligibility requirements.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: ASPERA-R Primary Outcome Measure: Baseline demographic characteristics
timeFrame: At the baseline (index ischemic stroke onset/hospital admission)
measure: ASPERA-R Primary Outcome Measure: Baseline clinical characteristics
timeFrame: At the baseline (index ischemic stroke onset/hospital admission)
measure: ASPERA-R Primary Outcome Measure: Baseline Neuroimaging characteristics
timeFrame: At the baseline (index ischemic stroke onset/hospital admission)
measure: ASPERA-P Primary Outcome Measure: New ischemic stroke or transient ischemic attack
timeFrame: 90-day, 1-year and 5-year post-stroke
Secondary outcomes:
measure: ASPERA-R Secondary Outcome Measure: All-cause mortality
timeFrame: Discharge and 90-day post-stroke
measure: ASPERA-R Secondary Outcome Measure: Vascular death
timeFrame: Discharge and 90-day post-stroke
measure: ASPERA-R Secondary Outcome Measure: New ischemic stroke or transient ischemic attack
timeFrame: Discharge and 90-day post-stroke
measure: ASPERA-R Secondary Outcome Measure: Myocardial infarction
timeFrame: Discharge and 90-day post-stroke
measure: ASPERA-R Secondary Outcome Measure: Moderate-to-severe bleeding events
timeFrame: Discharge and 90-day post-stroke
measure: ASPERA-R Secondary Outcome Measure: Intracranial hemorrhage
timeFrame: Discharge and 90-day post-stroke
measure: ASPERA-R Secondary Outcome Measure: Ordinal distribution of modified Rankin Scale scores
timeFrame: Discharge and 90-day post-stroke
measure: ASPERA-P Secondary Outcome Measure: All-cause mortality
timeFrame: 90-day, 1-year and 5-year post-stroke
measure: ASPERA-P Secondary Outcome Measure: Vascular death
timeFrame: 90-day, 1-year and 5-year post-stroke
measure: ASPERA-P Secondary Outcome Measure: Myocardial infarction
timeFrame: 90-day, 1-year and 5-year post-stroke
measure: ASPERA-P Secondary Outcome Measure: Intracranial Hemorrhage
timeFrame: 90-day, 1-year and 5-year post-stroke
measure: ASPERA-P Secondary Outcome Measure: Moderate-to-severe bleeding events
timeFrame: 90-day, 1-year and 5-year post-stroke
measure: ASPERA-P Secondary Outcome Measure: Minor bleeding events
timeFrame: 90-day, 1-year and 5-year post-stroke
measure: ASPERA-P Secondary Outcome Measure: Any bleeding events
timeFrame: 90-day, 1-year and 5-year post-stroke
measure: ASPERA-P Secondary Outcome Measure: Ordinal modified Rankin Scale scores distribution
timeFrame: 90-day, 1-year and 5-year post-stroke
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Department of Neurology, Sveti Duh University Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Bispebjerg Hospital
city: Assiut
country: Egypt
facility: Neurology Department, Assiut University Hospitals
city: Cairo
country: Egypt
facility: Neurology Department, Faculty of Medicine , Ain Shams University
city: Cairo
country: Egypt
facility: Neurology Unit, Kobry Elkoba Medical Complex
city: Nice
country: France
facility: Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2
city: Berlin
country: Germany
facility: Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB)
city: Halle (Saale)
country: Germany
facility: Department of Neurology, Martin-Luther-University of Halle-Wittenberg
city: Ancona
country: Italy
facility: Neurological Clinic, Marche Polytechnic University
city: Bari
country: Italy
facility: SC Neurologia, Stroke Unit, Ospedale di Venere
city: Bologna
country: Italy
facility: IRCCS Istituto delle Scienze Neurologiche
city: Città di Castello
country: Italy
facility: SCA Neurologia, USL Umbria 1
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna
city: Florence
country: Italy
facility: SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi
city: Frosinone
country: Italy
facility: Stroke Unit, Hospital Fabrizio Spazian
city: L'Aquila
country: Italy
facility: University of L'Aquila
city: Milan
country: Italy
facility: Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano Niguarda
city: Naples
country: Italy
facility: Neurology and Stroke Unit, AORN Antonio Cardarelli
city: Palermo
country: Italy
facility: UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello
city: Parma
country: Italy
facility: Department of Medicine and Surgery, University of Parma
city: Pavia
country: Italy
facility: Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino
city: Perugia
country: Italy
facility: Medicina Interna e d'Urgenza - Stroke Unit, Azienda Ospedaliera di Perugia
city: Pescara
country: Italy
facility: Department of Emergency Neurology and Stroke Unit, Pescara Hospital
city: Ravenna
country: Italy
facility: Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL Romagna
city: Reggio Emilia
country: Italy
facility: Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
city: Rome
country: Italy
facility: UOSD Stroke Unit, Azienda Ospedaliera San Camillo Forlanini
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: San Benedetto del Tronto
country: Italy
facility: UOC Neurologia, Ospedale Provinciale "Madonna del Soccorso"
city: Siena
country: Italy
facility: UOC Stroke Unit, Emergency and Urgency Department, AOU Senese
city: Teramo
country: Italy
facility: ASL Abruzzo 4, G.Mazzini Hospital
city: Udine
country: Italy
facility: SOSD Stroke Unit, Department of Head, Neck, and Neuroscience, Udine University Hospital
city: Verona
country: Italy
facility: Stroke Unit, Neurologia A, Azienda Ospedaliera Universitaria Integrata di Verona
city: Skopje
country: North Macedonia
facility: University Clinic of Neurology, University "Ss.Cyril and Methodius"-Faculty of Medicine
city: Krakow
country: Poland
facility: Department of Neurology, Jagiellonian University Medical College
city: Lisbon
country: Portugal
facility: Lisbon Central University Hospital - ULS São José and Faculdade de Medicina, Universidade de Lisboa
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
city: Bucharest
country: Romania
facility: Elias University Emergency Hospital, Carol Davila University of Medicine and Pharmacy
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
city: Riyadh
country: Saudi Arabia
facility: Vascular Neurology Division National Neuroscience Institute King Fahad Medical City
city: Kosice
country: Slovakia
facility: Department of Neurology, Faculty of Medicine, P. J. Safarik University and University Hospital L. Pasteur
city: Madrid
country: Spain
facility: La Paz University Hospital, Universidad Autónoma de Madrid, IdiPAZ Research Institute
city: Valladolid
country: Spain
facility: Department of Medicine, University of Valladolid
city: St. Gallen
country: Switzerland
facility: University Teaching Hospital St. Gallen
city: Bristol
country: United Kingdom
facility: Southmead Hospital, North Bristol NHS Trust
state: UK
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
state: UK
city: London
country: United Kingdom
facility: Department of Brain Sciences, Imperial College London
state: UK
city: London
country: United Kingdom
facility: Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College
state: UK
Study officials:
References: