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.
Study Type
OBSERVATIONAL
Enrollment
200
Department of Neurology, Sveti Duh University Hospital
Zagreb, Croatia
RECRUITINGCopenhagen University Hospital, Bispebjerg Hospital
Copenhagen, Denmark
RECRUITINGNeurology Department, Assiut University Hospitals
Asyut, Egypt
RECRUITINGNeurology Department, Faculty of Medicine , Ain Shams University
Cairo, Egypt
ASPERA-R Primary Outcome Measure: Baseline demographic characteristics
Baseline demographic characteristics of ischemic stroke cases occurring on oral anticoagulants: mean age (years), sex (proportion of males and females), ethnicity (proportion of non-Hispanic White, Hispanic White, Black, Asian, other ethnicities), mean weight (Kg), mean height (cm), median BMI
Time frame: At the baseline (index ischemic stroke onset/hospital admission)
ASPERA-R Primary Outcome Measure: Baseline clinical characteristics
Baseline clinical characteristics: type of oral anticoagulation at the time of index ischemic stroke (proportion of patients on DOAC or VKA), ischemic stroke clinical severity (median National Insititue of Health Stroke Scale - NIHSS), type of clinical presentation (proportion of patients with anterior or posterior circulation stroke), competing stroke etiology (proportion of patients with large-artery-atherosclerosis or lacunar or other determined or undetermined etiology), risk factors (proportion of patients with hypertension, dyslipidemia, diabetes, history of prior stroke/transient ischemic attack, ischemic cardiopaty, peripheral artery disease, chronic kidney or liver failure), acute ischemic stroke treatment (proportion of patients who undergo intravenous thrombolysis or endovascular thrombectomy)
Time frame: At the baseline (index ischemic stroke onset/hospital admission)
ASPERA-R Primary Outcome Measure: Baseline Neuroimaging characteristics
Baseline Neuroimaging characteristics: large vessel occlusion (proportion of patients with large vessel occlusion), site of large vessel occlusion (proportion of patients with anterior or middle or posterior cerebral arteries occlusion), degree of large vessel occlusion (according to the modified treatment in cerebral infarction - mTICI - score: from 0 - no perfusion - to 3 - complete perfusion), median number of new ischemic lesion(s) at neuroimaging, site of new ischemic lesion(s) at neuroimaging (anterior or posterior circulation, right or left hemisphere or bilateral), presence of hemorrhagic infarction at neuroimaging, degree of hemorrhagic infarction at neuroimaging (according to the Heidelberg classification system: Hemorrhagic Infarction - Small petechiae along the margins of the infarcted area or more confluent petechiae without space-occupying effect (HI2). Parenchymal Hematoma - A hematoma covering less (PH1) or more (PH2) than 30% of the infarcted area.
Time frame: At the baseline (index ischemic stroke onset/hospital admission)
ASPERA-P Primary Outcome Measure: New ischemic stroke or transient ischemic attack
New ischemic stroke or transient ischemic attack (proportion of patients with new ischemic stroke or transient ischemic attack)
Time frame: 90-day, 1-year and 5-year post-stroke
ASPERA-R Secondary Outcome Measure: All-cause mortality
All-cause mortality (proportion of patients who died due to any cause)
Time frame: Discharge and 90-day post-stroke
ASPERA-R Secondary Outcome Measure: Vascular death
Vascular death (death due to stroke, myocardial infarction, pulmonary embolism, sudden death or arrhythmias)
Time frame: Discharge and 90-day post-stroke
ASPERA-R Secondary Outcome Measure: New ischemic stroke or transient ischemic attack
New ischemic stroke or transient ischemic attack (proportion of patients with new ischemic stroke or transient ischemic attack)
Time frame: Discharge and 90-day post-stroke
ASPERA-R Secondary Outcome Measure: Myocardial infarction
Myocardial infarction (proportion of patients with any type of myocardial infarction)
Time frame: Discharge and 90-day post-stroke
ASPERA-R Secondary Outcome Measure: Moderate-to-severe bleeding events
Moderate-to-severe bleeding events (proportion of patients with moderate-to-severe bleedings as defined according to the GUSTO bleeding classification): GUSTO severe or life-threatening bleeding is defined as either intracranial haemorrhage or bleeding resulting in haemodynamic compromise necessitating intervention. GUSTO moderate bleeding is defined as bleeding requiring transfusion, but not resulting in haemodynamic compromise.
Time frame: Discharge and 90-day post-stroke
ASPERA-R Secondary Outcome Measure: Intracranial hemorrhage
Intracranial hemorrhage (any type of intracranial hemorrhage)
Time frame: Discharge and 90-day post-stroke
ASPERA-R Secondary Outcome Measure: Ordinal distribution of modified Rankin Scale scores
Ordinal distribution of modified Rankin Scale scores (proportion of patients within each category of the modified Rankin Scale): Symptoms without any disability (score of 1), Symptoms with mild disability (score of 2), Symptoms with mild-to-moderate disability (score of 3), Symptoms with moderate-to-severe disability (score of 4), Symptoms with severe disability (score of 5), Death (score of 6)
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Neurology Unit, Kobry Elkoba Medical Complex
Cairo, Egypt
RECRUITINGUniversité Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2
Nice, France
RECRUITINGDepartment of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB)
Berlin, Germany
RECRUITINGDepartment of Neurology, Martin-Luther-University of Halle-Wittenberg
Halle, Germany
RECRUITINGNeurological Clinic, Marche Polytechnic University
Ancona, Italy
RECRUITINGSC Neurologia, Stroke Unit, Ospedale di Venere
Bari, Italy
RECRUITING...and 37 more locations
Time frame: Discharge and 90-day post-stroke
ASPERA-P Secondary Outcome Measure: All-cause mortality
All-cause mortality (proportion of patients who died due to any cause)
Time frame: 90-day, 1-year and 5-year post-stroke
ASPERA-P Secondary Outcome Measure: Vascular death
Vascular death (death due to stroke, myocardial infarction, pulmonary embolism, sudden death or arrhythmias)
Time frame: 90-day, 1-year and 5-year post-stroke
ASPERA-P Secondary Outcome Measure: Myocardial infarction
Myocardial infarction (proportion of patients with any type of myocardial infarction)
Time frame: 90-day, 1-year and 5-year post-stroke
ASPERA-P Secondary Outcome Measure: Intracranial Hemorrhage
Intracranial hemorrhage (any type of intracranial hemorrhage)
Time frame: 90-day, 1-year and 5-year post-stroke
ASPERA-P Secondary Outcome Measure: Moderate-to-severe bleeding events
Moderate-to-severe bleeding events (proportion of patients with moderate-to-severe bleedings as defined according to the GUSTO bleeding classification): GUSTO severe or life-threatening bleeding is defined as either intracranial haemorrhage or bleeding resulting in haemodynamic compromise necessitating intervention. GUSTO moderate bleeding is defined as bleeding requiring transfusion, but not resulting in haemodynamic compromise.
Time frame: 90-day, 1-year and 5-year post-stroke
ASPERA-P Secondary Outcome Measure: Minor bleeding events
Minor bleeding events (proportion of patients with minor bleedings as defined according to the GUSTO bleeding classification): Any bleedings that is not intracranial haemorrhage or bleeding resulting in haemodynamic compromise necessitating intervention, or bleeding requiring transfusion.
Time frame: 90-day, 1-year and 5-year post-stroke
ASPERA-P Secondary Outcome Measure: Any bleeding events
Any bleeding events (proportion of patients with any bleedings irrespective of their severity)
Time frame: 90-day, 1-year and 5-year post-stroke
ASPERA-P Secondary Outcome Measure: Ordinal modified Rankin Scale scores distribution
Ordinal distribution of modified Rankin Scale scores (proportion of patients within each category of the modified Rankin Scale): Symptoms without any disability (score of 1), Symptoms with mild disability (score of 2), Symptoms with mild-to-moderate disability (score of 3), Symptoms with moderate-to-severe disability (score of 4), Symptoms with severe disability (score of 5), Death (score of 6)
Time frame: 90-day, 1-year and 5-year post-stroke