Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants - The ASPERA International Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 47
- 主要终点
- ASPERA-R Primary Outcome Measure: Baseline demographic characteristics
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
ASPERA-R Primary Outcome Measure: Baseline demographic characteristics
时间窗: At the baseline (index ischemic stroke onset/hospital admission)
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
ASPERA-R Primary Outcome Measure: Baseline clinical characteristics
时间窗: At the baseline (index ischemic stroke onset/hospital admission)
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)
ASPERA-R Primary Outcome Measure: Baseline Neuroimaging characteristics
时间窗: At the baseline (index ischemic stroke onset/hospital admission)
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.
ASPERA-P Primary Outcome Measure: New ischemic stroke or transient ischemic attack
时间窗: 90-day, 1-year and 5-year post-stroke
New ischemic stroke or transient ischemic attack (proportion of patients with new ischemic stroke or transient ischemic attack)
次要结局
- ASPERA-R Secondary Outcome Measure: All-cause mortality(Discharge and 90-day post-stroke)
- ASPERA-R Secondary Outcome Measure: Vascular death(Discharge and 90-day post-stroke)
- ASPERA-R Secondary Outcome Measure: New ischemic stroke or transient ischemic attack(Discharge and 90-day post-stroke)
- ASPERA-R Secondary Outcome Measure: Myocardial infarction(Discharge and 90-day post-stroke)
- ASPERA-R Secondary Outcome Measure: Moderate-to-severe bleeding events(Discharge and 90-day post-stroke)
- ASPERA-R Secondary Outcome Measure: Intracranial hemorrhage(Discharge and 90-day post-stroke)
- ASPERA-R Secondary Outcome Measure: Ordinal distribution of modified Rankin Scale scores(Discharge and 90-day post-stroke)
- ASPERA-P Secondary Outcome Measure: All-cause mortality(90-day, 1-year and 5-year post-stroke)
- ASPERA-P Secondary Outcome Measure: Vascular death(90-day, 1-year and 5-year post-stroke)
- ASPERA-P Secondary Outcome Measure: Myocardial infarction(90-day, 1-year and 5-year post-stroke)
- ASPERA-P Secondary Outcome Measure: Intracranial Hemorrhage(90-day, 1-year and 5-year post-stroke)
- ASPERA-P Secondary Outcome Measure: Moderate-to-severe bleeding events(90-day, 1-year and 5-year post-stroke)
- ASPERA-P Secondary Outcome Measure: Minor bleeding events(90-day, 1-year and 5-year post-stroke)
- ASPERA-P Secondary Outcome Measure: Any bleeding events(90-day, 1-year and 5-year post-stroke)
- ASPERA-P Secondary Outcome Measure: Ordinal modified Rankin Scale scores distribution(90-day, 1-year and 5-year post-stroke)
研究者
Simona Sacco
Professor
University of L'Aquila