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Taking people in ItalyNo phase

Studies stroke in people with irregular heartbeat who take blood thinners

Looks at strokes in people with atrial fibrillation who take oral anticoagulants.

Key facts

Who runs it
University of L'Aquila
Where
Ancona, Bari, Bologna, Città di Castello, Ferrara, Florence, Frosinone, L’Aquila, Milan, Naples, Palermo, Parma, Pavia, Perugia, Pescara, Ravenna, Reggio Emilia, Rome, San Benedetto del Tronto, Siena, Teramo, Udine, and Verona, ItalySee the 24 sitesAlso in 14 other countries, 23 sites
Trial code
Registry title
Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants
Status
Recruiting
People taking part
200 people, planned
Started
12 Feb 2025
Expected to end
12 Feb 2031
Type of study
Observational, 2 groups
Record updated
20 February 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had an ischemic stroke while taking blood-thinning tablets for atrial fibrillation or another heart rhythm problem.

Age
18 years or older at the time of the stroke
Sex
All sexes can join
Disease stage
Confirmed ischemic stroke, with a brain scan (CT or MRI) showing one or more ischemic lesions that fit the symptoms
Earlier treatment
Must have been taking oral blood thinners at the time of the stroke (last dose within 48 hours before symptoms for DOACs, or INR of 1.5 or higher for vitamin K antagonists)

Main reasons for not taking part

  • Symptoms not showing an acute stroke (for example fainting, seizure-like activity, dizziness alone, confusion or amnesia alone)
  • Slowly developing weakness or other focal nerve problems
  • Blood thinner given by injection or drip at the time of the stroke, including heparin bridging when starting a vitamin K antagonist

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Italy

Also in 14 other countries, 23 sites

  • Neurological Clinic, Marche Polytechnic UniversityAncona, ItalyContact: Giovanna Viticchi, MDTaking people
  • SC Neurologia, Stroke Unit, Ospedale di VenereBari, ItalyContact: Giuseppe Rinaldi, MDTaking people
  • Irccs - Istituto Delle Scienze NeurologicheBologna, ItalyContact: Maria Guarino, MDTaking people
  • SCA Neurologia, USL Umbria 1Città di Castello, ItalyContact: Silvia CenciarelliTaking people
  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'AnnaFerrara, ItalyContact: Maurizio 44124 Paciaroni, MDTaking people
  • SOD Stroke Unit, Azienda Ospedaliero Universitaria CareggiFlorence, ItalyContact: Patrizia Nencini, MDTaking people
  • Stroke Unit, Hospital Fabrizio SpazianFrosinone, ItalyContact: Maria Rosaria Bagnato, MDTaking people
  • University of L'AquilaL’Aquila, ItalyContact: Simona Sacco, MDTaking people
  • Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyContact: Angelo Cascio Rizzo, MDTaking people
  • Neurology and Stroke Unit, AORN Antonio CardarelliNaples, ItalyContact: Paolo Candelaresi, MDTaking people
  • UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - CervelloPalermo, ItalyContact: Marina Mannino, MDTaking people
  • Department of Medicine and Surgery, University of ParmaParma, ItalyContact: Alessandro Pezzini, MDTaking people
  • Department of Emergency Neurology and Stroke Unit, IRCCS C. MondinoPavia, ItalyContact: Federica Ferrari, MD, PhDTaking people
  • Medicina Interna e d'Urgenza - Stroke Unit, Azienda Ospedaliera di PerugiaPerugia, ItalyContact: Maria Giulia Mosconi, MD, PhDTaking people
  • Department of Emergency Neurology and Stroke Unit, Pescara HospitalPescara, ItalyContact: Maria Vittoria De Angelis, MD, PhDTaking people
  • Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL RomagnaRavenna, ItalyContact: Lucia Pavolucci, MDTaking people
  • Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio EmiliaReggio Emilia, ItalyContact: Maria Luisa Zedde, MDTaking people
  • Fondazione Policlinico Universitario Agostino GemelliRome, ItalyContact: Giovanni Frisullo, MD, PhDTaking people
  • UOSD Stroke Unit, Azienda Ospedaliera San Camillo ForlaniniRome, ItalyContact: Sabrina Anticoli, MDTaking people
  • UOC Neurologia, Ospedale Provinciale "Madonna del Soccorso"San Benedetto del Tronto, ItalyContact: Giulio Papiri, MDTaking people
  • UOC Stroke Unit, Emergency and Urgency Department, AOU SeneseSiena, ItalyContact: Rossana Tassi, MDTaking people
  • ASL Abruzzo 4, G.Mazzini HospitalTeramo, ItalyContact: Chiara Di Felice, MDTaking people
  • SOSD Stroke Unit, Department of Head, Neck, and Neuroscience, Udine University HospitalUdine, ItalyContact: Giovanni Merlino, MD, PhDTaking people
  • Stroke Unit, Neurologia A, Azienda Ospedaliera Universitaria Integrata di VeronaVerona, ItalyContact: Manuel Cappellari, MDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • 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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants - The ASPERA International Registry
Plain-language title
Studies stroke in people with irregular heartbeat who take blood thinnersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
20 February 2025