NCT06823466: ASPERA

Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants

Recruiting now Last updated 20 February 2025

What this trial tests

trial in Ischemic Stroke in 200 participants. Currently enrolling.

Timeline

12 February 2025

Primary endpoint
12 February 2027

12 February 2031

Quick facts

Lead sponsor	University of L'Aquila
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	200
Start date	12 February 2025
Primary completion	12 February 2027
Estimated completion	12 February 2031
Sites	47 locations across Denmark, France, Italy, North Macedonia, Slovakia, Saudi Arabia, United Kingdom, Germany

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →
• Oral Anticoagulation — all drugs for Oral Anticoagulation →
• Atrial Fibrillation (AF) — all drugs for Atrial Fibrillation (AF) →
• Outcome Assessment — all drugs for Outcome Assessment →

Sponsor

University of L'Aquila

Who can join

18 and older, any sex, with Ischemic Stroke or Oral Anticoagulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sex Differences in Outcomes After Breakthrough Ischemic Stroke on Oral Anticoagulants for Atrial Fibrillation: An ASPERA-R Inverse Probability Weighted Analysis.
   Foschi M, D'Anna L, Gabriele F, Ornello R, et al · · 2026 · cited 1× · PMID 41914366 · DOI 10.1161/jaha.125.047064
2. ABSTRACT NUMBER: ESOC2026A681 CHARACTERISTICS AND CAUSAL FACTORS OF BREAKTHROUGH ISCHEMIC STROKE DESPITE ONGOING ORAL ANTICOAGULATION IN PATIENTS WITH ATRIAL FIBRILLATION: THE ASPERA-R STUDY
   · 2026
3. Competing Stroke Etiologies and Outcomes After Breakthrough Ischemic Stroke on Oral Anticoagulants in Patients With Atrial Fibrillation.
   Foschi M, De Santis F, Gabriele F, Ornello R, et al · · 2026 · PMID 41974022 · DOI 10.1212/wnl.0000000000214758
4. Impact of cancer on outcomes following breakthrough ischaemic stroke on oral anticoagulants for atrial fibrillation: insights from the ASPERA-R study.
   Foschi M, De Santis F, Gabriele F, D'Anna L, et al · · 2026 · PMID 41758563 · DOI 10.1093/esj/aakag015