1. Inici
  2. Projectes i Estudis Clínics
  3. Ensayo fase III multicéntrico, internacional, aleatorizado, controlado con placebo, doble ciego, de grupos paralelos y determinado por eventos, del inhibidor oral del FXIa -Asundexian (BAY 2433334), para la prevención de ictus isquémicos en pacientes de ambos sexos mayores de edad, tras un ictus isquémico no cardioembólico agudo o AIT de alto riesgo.

Ensayo fase III multicéntrico, internacional, aleatorizado, controlado con placebo, doble ciego, de grupos paralelos y determinado por eventos, del inhibidor oral del FXIa -Asundexian (BAY 2433334), para la prevención de ictus isquémicos en pacientes de ambos sexos mayores de edad, tras un ictus isquémico no cardioembólico agudo o AIT de alto riesgo.

Dades bàsiques

Protocol:
20604
EURDRACT:
2022-001067-27
NCT:
Centre:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Any inici:
2023
Any de finalització:
ENSAYO CLÍNICO

Objectius del projecte

Objetivo Principal: Eficacia Evaluar si el inhibidor oral del FXIa asundexian es superior al placebo en la reducción de ictus isquémico en pacientes tratados con antiagregantes plaquetarios de base, tras un ictus isquémico no cardioembólico agudo o un ataque isquémico transitorio de alto riesgo (AIT) Seguridad Comparar la incidencia de hemorragia mayor según la Sociedad Internacional de Trombosis y Hemostasia (ISTH) entre asundexian y placebo cuando se administra junto a antiagregantes plaquetarios de base en pacientes tras un ictus isquémico no cardioembólico agudo o un ataque isquémico transitorio de alto riesgo. Objetivos Secundarios: Eficacia Evaluar si asundexian es superior a placebo, añadido al tratamiento antiagregante plaquetario de base, en la reducción de aparición de criterios de valoración de la eficacia combinados o individuales. Seguridad Comparar asundexian con placebo ,añadido al tratamiento antiagregante plaquetario de base, respecto a los criterios de valoración individuales de sangrado. Beneficio clínico neto Seguir comparando el beneficio y riesgo de asundexian y placebo respecto a la combinación de los objetivos de eficacia y seguridad

Documents

  • No hi ha documents

Participants

Veure tots els Investigadors

Grups d'Investigació

Finançadors - Promotors

BAYER AG

Resultats de l'Assaig Clínic

[Translated article] Knowledge of biological therapy in patients with immune-mediated diseases. BIOINFO study.

Segui-Solanes, Carlos; (...); Borras-Blasco, Joaquin

Article. 10.1016/j.farma.2024.08.002. 2024

  • Open Access.

[Translated article] New challenges in advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2024.05.001. 2024

  • Open Access.

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025


A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.

Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose

Article. 10.3390/ijms25042112. 2024

  • Open Access.

Association of cholesterol levels with hemorrhagic transformation and cerebral edema after reperfusion therapies.

Escudero-Martinez, Irene; (...); Ahmed, Niaz

Article. 10.1177/23969873221148229. 2023

  • Open Access.

Automatic etiological classification of stroke thrombus digital photographs using a deep learning model

Lucero-Garofano, Alvaro; (...); Manjon, Jose V.

Article. 10.3389/fneur.2025.1534845. 2025

  • Open Access.

Benefits of physical activity self-monitoring in patients with haemophilia: a prospective study with one-year follow-up.

Pérez-Alenda S; (...); Núñez-Cortés R

Article. 10.1111/hae.14988. 2024

  • Open Access.

Common and specific proteins and pathways in heart and cerebral ischemia

Pala, Elena; (...); Montaner, Joan

Article. 10.1016/j.jstrokecerebrovasdis.2023.107467. 2024


Cost-effectiveness and cost-utility analysis of haemate-P versus other von willebrand disease treatments in Spain.

Megias-Vericat, Juan E; (...); Yan, Songkai

Article. 10.1080/13696998.2025.2474886. 2025


Development and testing of a mobile app for systematic collection of patient-reported outcomes (PROs) in patients with hemophilia.

Megias-Vericat, J E; (...); Poveda Andres, J L

Letter. 10.1016/j.thromres.2024.109122. 2024


Distal Access Catheter Improves Balloon Guide and Stent Retriever Thrombectomy Outcomes in Nonagenarians.

Puig, Josep; (...); Blasco, Jordi

Article. 10.1111/jon.70012. 2025


Drug-drug interactions associated with FLT3 inhibitors for acute myeloblastic leukemia: current landscape.

Solana-Altabella, Antonio; (...); Montesinos, Pau

Article. 10.1080/17512433.2023.2174523. 2023


Enhancing the First-Pass Effect in Acute Stroke: The Impact of Stent Retriever Characteristics

Murias, Eduardo; (...); Vega, Pedro

Article. 10.3390/jcm13113123. 2024

  • Open Access.

Expanding the Clinical Spectrum of DRP2-Associated Charcot-Marie-Tooth Disease.

Sivera R; (...); Sevilla T

Article. 10.1212/WNL.0000000000209174. 2024


HIGH CELL-FREE HEMOGLOBIN AND IRON LEVELS IN CLOTS OF COVID-19 STROKE PATIENTS: A NOVEL MECHANISM LINKED TO SARS-COV-2 INDUCED PROTHROMBOTIC STATE

Paya, M.; (...); Segura, T.

Meeting Abstract. 2024


Incidence and Risk Factors for Development of Cardiac Toxicity in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia

Boluda, Blanca; (...); Montesinos, Pau

Article. 10.3390/cancers15082267. 2023

  • Open Access.

Mental, emotional and social dimensions of quality of life and their relationship with physical and functional status in adults with haemophilia.

Rodríguez MA; (...); Chimeno-Hernández A

Article. 10.1016/j.thromres.2024.109181. 2024

  • Open Access.

New challenges of advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2023.11.008. 2024

  • Open Access.

Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

  • Open Access.

Reperfusion By Endovascular Thrombectomy And Early Cerebral Edema In Anterior Circulation Stroke: Results From The Sits- International Stroke Thrombectomy Registry.

Thoren, Magnus; (...); Ahmed, Niaz

Article. 10.1177/17474930231180451. 2023

  • Open Access.

Safety and Efficacy of ApTOLL in Patients With Ischemic Stroke Undergoing Endovascular Treatment: A Phase 1/2 Randomized Clinical Trial.

Hernandez-Jimenez, Macarena; (...); Ribo, Marc

Article. 10.1001/jamaneurol.2023.1660. 2023

  • Open Access.

Safety and efficacy of tirofiban in acute ischemic stroke due to tandem lesions undergoing mechanical thrombectomy: A multicenter randomized clinical trial (ATILA) protocol.

Medina-Rodriguez, Manuel; (...); Zapata-Arriaza, Elena

Article. 10.1177/23969873221146383. 2023

  • Open Access.

Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial)

Zapata-Arriaza, Elena; (...); Gonzalez Garcia, Alejandro

Article. 10.1186/s13063-023-07817-9. 2024

  • Open Access.

The cross-sectional area of the median nerve: An independent prognostic biomarker in amyotrophic lateral sclerosis.

Martinez-Paya, J J; (...); Vazquez-Costa, J F

Article. 10.1016/j.nrleng.2024.07.003. 2024

  • Open Access.

Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.

Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis

Article. 10.1136/ejhpharm-2024-004184. 2024


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