Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT06823466

Acronym / sponsor ID

ASPERA / 2696 - 22/07/2024

Conditions

Ischemic Stroke, Oral Anticoagulation, Atrial Fibrillation (AF), Outcome Assessment, Clinical Presentations

Keywords

Ischemic stroke, Oral anticoagulation, Atrial fibrillation, Direct oral anticoagulants, Vitamin k antagonists, Outcomes, Prognosis, Clinical characteristics

Study type

Observational

Recruitment status

Recruiting

Enrolment

200 participants (estimated)

Lead sponsor

University of L'AquilaUniversity, hospital or other

Study start

12 Feb 2025 (actual)

Primary completion

12 Feb 2027 (estimated)

Study completion

12 Feb 2031 (estimated)

First posted

12 Feb 2025 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Other

Target follow-up

5 Years

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
• Derived from this study: PubMed 41974022Foschi M, De Santis F, Gabriele F, Ornello R, D'Anna L, Zini A, Paolucci M, Forlivesi S, Migliaccio L, Viola MM, Cascio Rizzo A, Sessa M, Schwarz G, Tortorella R, Banerjee S, Desai G, Ahmed KF, Prandin G, Pantoni L, Mele F, Scopelliti G, Cova I, Valente M, Maisano D, Antonelli L, Bagnato MR, Di Mauro G, Bernocchi F, Di Donna MG, Casolla B, Mazloum P, Campisi C, Caraux A, Gonzalez-Martin L, Rigual R, Fuentes B, Hervas-Testal C, Candelaresi P, Andreone V, De Mase A, Spina E, Aguiar De Sousa D, Souza MA, Fior A, Serodio M, Caliandro P, Zauli A, Reale G, Abdelalim A, Ahmed S, Ismail SA, Zhang L, Latimer T, Elboghdady M, Elbassiouny A, Roushdy T, Shokri H, Ferrari F, Loizzo ND, Mazzacane F, Guarino M, Barone V, Forti P, Rinaldi G, Rossi MV, Laterza V, Frisullo G, Rizzo PA, Broccolini A, Mannino M, Terruso V, Caggiula M, Rizzo A, Fonseca AC, Antunes B, Barbosa AM, Budincevic H, Crnac P, Viticchi G, Silvestrini M, Barba L, Musienko V, Otto M, Lochner P, Landau B, Buddha S, Khalil R, Piscaglia MG, Minguzzi E, Zedde M, Nasreldein A, Vinciguerra L, Costa LR, Elsayed AE, AlBanna M, Tudisco L, Mosconi MG, Polymeris AA, Merlino G, Sacco S. Competing Stroke Etiologies and Outcomes After Breakthrough Ischemic Stroke on Oral Anticoagulants in Patients With Atrial Fibrillation. Neurology. 2026 May 12;106(9):e214758. doi: 10.1212/WNL.0000000000214758. Epub 2026 Apr 13.
• Derived from this study: PubMed 41758563Foschi M, De Santis F, Gabriele F, D'Anna L, Zini A, Paolucci M, Forlivesi S, Migliaccio L, Viola MM, Rizzo AC, Sessa M, Schwarz G, Tortorella R, Banerjee S, Desai G, Jaffar M, Prandin G, Pantoni L, Mele F, Scopelliti G, Cova I, Valente M, Maisano D, Antonelli L, Bagnato MR, Di Mauro G, Bernocchi F, Di Donna MG, Casolla B, Mazloum MP, Kacani K, Djeghlal NA, Gonzalez-Martin L, Rigual R, Fuentes B, Hervas C, Candelaresi P, Andreone V, De Mase A, Spina E, de Sousa DA, Souza MA, Fior A, Serodio M, Caliandro P, Zauli A, Reale G, Abdelalim A, Ahmed S, Soliman NM, Zhang L, Latimer T, Elboghday M, Elbassiouny AA, Roushdy T, Shokri H, Ferrari F, Loizzo ND, Mazzacane F, Guarino M, Barone V, Forti P, Rinaldi G, Rossi MV, Laterza V, Frisullo G, Rizzo PA, Broccolini A, Mannino M, Terruso V, Caggiula M, Rizzo A, Fonseca AC, Antunes B, Barbosa AM, Budincevic H, Crnac P, Viticchi G, Silvestrini M, Barba L, Otto M, Lochner P, Landau B, Buddha S, Khalil R, Piscaglia MG, Minguzzi E, Zedde M, Nasreldein A, Vinciguerra L, Costa L, Elsayed AE, AlBanna M, Tudisco L, Mosconi MG, Merlino G, Polymeris A, Ornello R, Sacco S. Impact of cancer on outcomes following breakthrough ischaemic stroke on oral anticoagulants for atrial fibrillation: insights from the ASPERA-R study. Eur Stroke J. 2026 Feb 9;11(2):aakag015. doi: 10.1093/esj/aakag015.
• Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

47 sites in 15 countries: see every site and its status.