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NCT Number: NCT06823466

Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants

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.

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Key information

Conditions

Ischemic Stroke Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Clinical Presentations Heart Diseases Nervous System Diseases Oral Anticoagulation Outcome Assessment Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Sveti Duh University Hospital, Zagreb, Croatia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. ASPERA-R Primary Outcome Measure: Baseline demographic characteristics

    Time frame: 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

  2. ASPERA-R Primary Outcome Measure: Baseline clinical characteristics

    Time frame: 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)

  3. ASPERA-R Primary Outcome Measure: Baseline Neuroimaging characteristics

    Time frame: 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.

  4. ASPERA-P Primary Outcome Measure: New ischemic stroke or transient ischemic attack

    Time frame: 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)

Secondary outcomes

  1. ASPERA-R Secondary Outcome Measure: All-cause mortality

    Time frame: Discharge and 90-day post-stroke

    All-cause mortality (proportion of patients who died due to any cause)

  2. ASPERA-R Secondary Outcome Measure: Vascular death

    Time frame: Discharge and 90-day post-stroke

    Vascular death (death due to stroke, myocardial infarction, pulmonary embolism, sudden death or arrhythmias)

  3. ASPERA-R Secondary Outcome Measure: New ischemic stroke or transient ischemic attack

    Time frame: Discharge and 90-day post-stroke

    New ischemic stroke or transient ischemic attack (proportion of patients with new ischemic stroke or transient ischemic attack)

  4. ASPERA-R Secondary Outcome Measure: Myocardial infarction

    Time frame: Discharge and 90-day post-stroke

    Myocardial infarction (proportion of patients with any type of myocardial infarction)

  5. ASPERA-R Secondary Outcome Measure: Moderate-to-severe bleeding events

    Time frame: Discharge and 90-day post-stroke

    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.

  6. ASPERA-R Secondary Outcome Measure: Intracranial hemorrhage

    Time frame: Discharge and 90-day post-stroke

    Intracranial hemorrhage (any type of intracranial hemorrhage)

  7. ASPERA-R Secondary Outcome Measure: Ordinal distribution of modified Rankin Scale scores

    Time frame: Discharge and 90-day post-stroke

    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)

  8. ASPERA-P Secondary Outcome Measure: All-cause mortality

    Time frame: 90-day, 1-year and 5-year post-stroke

    All-cause mortality (proportion of patients who died due to any cause)

  9. ASPERA-P Secondary Outcome Measure: Vascular death

    Time frame: 90-day, 1-year and 5-year post-stroke

    Vascular death (death due to stroke, myocardial infarction, pulmonary embolism, sudden death or arrhythmias)

  10. ASPERA-P Secondary Outcome Measure: Myocardial infarction

    Time frame: 90-day, 1-year and 5-year post-stroke

    Myocardial infarction (proportion of patients with any type of myocardial infarction)

  11. ASPERA-P Secondary Outcome Measure: Intracranial Hemorrhage

    Time frame: 90-day, 1-year and 5-year post-stroke

    Intracranial hemorrhage (any type of intracranial hemorrhage)

  12. ASPERA-P Secondary Outcome Measure: Moderate-to-severe bleeding events

    Time frame: 90-day, 1-year and 5-year post-stroke

    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.

  13. ASPERA-P Secondary Outcome Measure: Minor bleeding events

    Time frame: 90-day, 1-year and 5-year post-stroke

    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.

  14. ASPERA-P Secondary Outcome Measure: Any bleeding events

    Time frame: 90-day, 1-year and 5-year post-stroke

    Any bleeding events (proportion of patients with any bleedings irrespective of their severity)

  15. ASPERA-P Secondary Outcome Measure: Ordinal modified Rankin Scale scores distribution

    Time frame: 90-day, 1-year and 5-year post-stroke

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Matteo Foschi, MD

CONTACT

[email protected]

+39 3478929126

Simona Sacco, MD

CONTACT

[email protected]

+39 0862433561

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Official study title

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

Acronym: ASPERA

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Feb 12, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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