Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants (ASPERA)

February 17, 2025 updated by: Simona Sacco, University of L'Aquila

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

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • Department of Neurology, Sveti Duh University Hospital
        • Contact:
  • Denmark
  • Egypt
      • Assiut, Egypt, 71526
        • Recruiting
        • Neurology Department, Assiut University Hospitals
        • Contact:
      • Cairo, Egypt, 11566
        • Recruiting
        • Neurology Department, Faculty of Medicine , Ain Shams University
        • Contact:
      • Cairo, Egypt, 11799
        • Recruiting
        • Neurology Unit, Kobry Elkoba Medical Complex
        • Contact:
  • France
      • Nice, France, 06001
        • Recruiting
        • Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2
        • Contact:
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB)
        • Contact:
      • Halle (Saale), Germany, 06112
        • Recruiting
        • Department of Neurology, Martin-Luther-University of Halle-Wittenberg
        • Contact:
  • Italy
      • Ancona, Italy, 60126
      • Bari, Italy, 70131
      • Bologna, Italy, 40139
      • Città di Castello, Italy, 06012
      • Ferrara, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna
        • Contact:
      • Florence, Italy, 50134
      • Frosinone, Italy, 03100
      • L'Aquila, Italy, 67100
      • Milan, Italy, 20162
      • Naples, Italy, 80131
      • Palermo, Italy
        • Recruiting
        • UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello
        • Contact:
      • Parma, Italy, 43126
        • Recruiting
        • Department of Medicine and Surgery, University of Parma
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino
        • Contact:
      • Perugia, Italy, 06132
      • Pescara, Italy, 65124
        • Recruiting
        • Department of Emergency Neurology and Stroke Unit, Pescara Hospital
        • Contact:
      • Ravenna, Italy, 48124
        • Recruiting
        • Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL Romagna
        • Contact:
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
        • Contact:
      • Rome, Italy, 00168
      • Rome, Italy, 00152
      • San Benedetto del Tronto, Italy, 63074
      • Siena, Italy, 53100
        • Recruiting
        • UOC Stroke Unit, Emergency and Urgency Department, AOU Senese
        • Contact:
      • Teramo, Italy, 64100
      • Udine, Italy, 33100
      • Verona, Italy, 37126
        • Recruiting
        • Stroke Unit, Neurologia A, Azienda Ospedaliera Universitaria Integrata di Verona
        • Contact:
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Recruiting
        • University Clinic of Neurology, University "Ss.Cyril and Methodius"-Faculty of Medicine
        • Contact:
  • Poland
      • Krakow, Poland, 30-688
        • Recruiting
        • Department of Neurology, Jagiellonian University Medical College
        • Contact:
  • Portugal
      • Lisbon, Portugal, 1649-028
        • Recruiting
        • Lisbon Central University Hospital - ULS São José and Faculdade de Medicina, Universidade de Lisboa
        • Contact:
      • Lisbon, Portugal, 1649-035
  • Romania
      • Bucharest, Romania, 050474
        • Recruiting
        • Elias University Emergency Hospital, Carol Davila University of Medicine and Pharmacy
        • Contact:
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11426
      • Riyadh, Saudi Arabia, 11525
        • Recruiting
        • Vascular Neurology Division National Neuroscience Institute King Fahad Medical City
        • Contact:
  • Slovakia
      • Kosice, Slovakia, 040 11
        • Recruiting
        • Department of Neurology, Faculty of Medicine, P. J. Safarik University and University Hospital L. Pasteur
        • Contact:
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • La Paz University Hospital, Universidad Autónoma de Madrid, IdiPAZ Research Institute
        • Contact:
      • Valladolid, Spain, 47005
  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Recruiting
        • University Teaching Hospital St. Gallen
        • Contact:
  • United Kingdom
    • UK
      • Bristol, UK, United Kingdom, BS10 5N
      • London, UK, United Kingdom, SW17 0QT
      • London, UK, United Kingdom, W12 0NN
        • Recruiting
        • Department of Brain Sciences, Imperial College London
        • Contact:
      • London, UK, United Kingdom, W6 8RF
        • Recruiting
        • Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ASPERA-R
Retrospectively enrolled schemic stroke patients on oral anticoagulants at the time of the index stroke followed up at hospital discharge and 90 days post-stroke
ASPERA-P
Prospectively enrolled ischemic stroke patients on oral anticoagulants at the time of the index stroke followed up at 90 days, 1 year and 5 years post-stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the baseline (index ischemic stroke onset/hospital admission)
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)
At the baseline (index ischemic stroke onset/hospital admission)
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.
At the baseline (index ischemic stroke onset/hospital admission)
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)
90-day, 1-year and 5-year post-stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Discharge and 90-day post-stroke
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)
Discharge and 90-day post-stroke
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)
Discharge and 90-day post-stroke
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)
Discharge and 90-day post-stroke
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.
Discharge and 90-day post-stroke
ASPERA-R Secondary Outcome Measure: Intracranial hemorrhage
Time Frame: Discharge and 90-day post-stroke
Intracranial hemorrhage (any type of intracranial hemorrhage)
Discharge and 90-day post-stroke
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)
Discharge and 90-day post-stroke
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)
90-day, 1-year and 5-year post-stroke
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)
90-day, 1-year and 5-year post-stroke
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)
90-day, 1-year and 5-year post-stroke
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)
90-day, 1-year and 5-year post-stroke
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.
90-day, 1-year and 5-year post-stroke
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.
90-day, 1-year and 5-year post-stroke
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)
90-day, 1-year and 5-year post-stroke
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)
90-day, 1-year and 5-year post-stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2025

Primary Completion (Estimated)

February 12, 2027

Study Completion (Estimated)

February 12, 2031

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2696 - 22/07/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share individual clinical data collected in the study with other researchers upon reasonable request, in line with ethical guidelines and data protection regulations. Data will be de-identified to protect participant confidentiality.

IPD Sharing Time Frame

From the end of the ASPERA-P study (10/02/2029) up to 10 years (10/02/2039)

IPD Sharing Access Criteria

Access will be granted for purposes of replicating findings, conducting meta-analyses, or pursuing related research questions, subject to approval by the study's data governance committee and appropriate institutional review boards. Researchers will be required to sign data-sharing agreements to ensure proper use and compliance with confidentiality standards.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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