Fiche traitement
DOAC
Insel Gruppe AG, University Hospital Bern • Accident vasculaire cérébral
Suivi actif
Non applicable
Résumé
DOAC est développé par Insel Gruppe AG, University Hospital Bern. Le traitement est actuellement en Non applicable. Il est associé à Accident vasculaire cérébral. Son objectif thérapeutique principal est Traitement symptomatique. Le statut actuel est : suivi actif.
À vérifier
Traitement symptomatique
Non applicable
Insel Gruppe AG, University Hospital Bern
Belgium, Germany, New Zealand, Spain, Switzerland, United Kingdom
Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF. Despite DOAC therapy, there is a significant residual stroke risk of 1-2%/year. Recent data from the Swiss Stroke Registry found 38% of patients with AF and ischemic stroke were on prior anticoagulant therapy (approximately 400 patients per year in Switzerland). The investigators found in a prior observational study, that patients with AF who have ischemic stroke despite anticoagulation are at increased risk of having another ischemic stroke (HR 1.6; 95% confidence interval, CI 1.1-2.1). Combining observational data from 11 international stroke centres, the investigators found that the majority of ischemic strokes despite anticoagulation in patients with AF is "breakthrough" cardioembolism (76% of patients) and only a minority of 24% is related to other causes unrelated to AF. Optimal secondary prevention strategy is unknown. The investigators have conducted two independent observational studies including together \>4000 patients but did not identify any strategy (e.g. switch to different DOAC, additional antiplatelet therapy) that seems superior. A recent randomized controlled trial on surgical occlusion of the left atrial appendage (LAAO) found that LAAO may provide additional protection from ischaemic stroke in addition to oral anticoagulation. Triggered by this finding, the investigators performed a matched retrospective observational study and found that patients with AF and stroke despite anticoagulation who received a combined mechanical-pharmacological therapy (DOAC therapy + LAAO) had lower rates of adverse outcomes compared to those with DOAC therapy alone. Therefore, the investigators hypothesize that in patients with AF and ischemic stroke despite anticoagulant therapy, LAAO in addition to anticoagulation with a DOAC is superior to DOAC therapy alone. The investigators propose an international, multi-center randomized controlled two-arm trial to assess the effect of LAAO in patients with AF suffering from strokes despite anticoagulation therapy and without competing stroke etiology. The investigators will use the PROBE design with blinded endpoint assessment. The investigators will enrol patients with non-valvular AF and a recent ischemic stroke despite anticoagulation therapy at stroke onset. Patients will be randomized 1:1 to receive LAAO + DOAC therapy (experimental arm) or DOAC therapy alone (standard treatment arm). The primary endpoint is the first occurrence of a composite outcome of recurrent ischemic stroke, systemic embolism and cardiovascular death during follow-up. Secondary outcomes include individual components of the primary composite outcome, safety outcomes (i.e. symptomatic intracranial haemorrhage, major extracranial bleeding, serious device- or procedure-related complication), functional outcome (modified Rankin Scale) and patient-oriented outcomes. The minimum follow-up is 6 months and all patients will receive follow-ups every 6 months until end of study, the maximal follow-up will be 48 months. Based on prior observational data from the investigators' group and others (5 observational studies, \>5000 patients), the investigators estimate the proportion of patients with the primary outcome in the standard treatment arm to be 18% in the first year and 9% in the second year (=cumulative 27% after 2 years). A relative risk reduction of 40% at 2 years would be clinically relevant. Based on these assumptions and a log-rank test, the investigators would need 98 events for a power of 80% at an alpha-level of 5%. Assuming a recruitment rate of 52, 118, 156 and 156 patients in years 1 to 4, an additional 6 months of follow-up (mean follow-up time of 2.1 years) and a uniform drop-out rate of 7.5% per year, 482 patients would need to be enrolled. How to treat patients with an ischemic stroke despite anticoagulation is a major yet unresolved clinical dilemma. This trial has the potential to answer the question whether LAAO plus DOAC therapy is superior to current standard of care for patients with AF who have ischemic stroke despite anticoagulation.
2026-11-05
Début phase actuelle
Non disponible dans les sources synchronisées
Timeline clinique
Non applicable
Début phase actuelle
Non disponible dans les sources synchronisées
Préclinique
Phase 1
Phase 2
Phase 3
Approuvé
Objectif scientifique de l’étude
classification automatique vérifiable
Traitement symptomatique
Confiance automatique : 66%
Ce pourcentage n’est pas une probabilité de succès clinique.
Il mesure uniquement la force de la classification automatique de l’objectif scientifique. Le calcul part de 45 points, ajoute 7 points par unité de poids du mot-clé le plus fortement détecté, puis est plafonné à 95 %. Exemple : un score maximal de 2 donne 45 + (2 × 7) = 59 %.
Indices détectés : symptom → Traitement symptomatique
Ce score est heuristique et doit être vérifié dans le protocole ou une publication.
Description affichée depuis l’essai compatible NCT05976685, afin d’éviter le mélange entre plusieurs indications d’une même molécule.
Aucune incohérence majeure détectée entre la maladie, l’objectif et la description.
Transparence et qualité de la fiche
données vérifiablesClassificationCohérente automatiquement
Confiance de la fiche100 %
Source principaleSource officielle ou publication indexée
Dernière vérification2026-11-05
Anomalies détectées0
Validation humaineValidation humaine non effectuée
Donnée issue d’une source
Donnée normalisée automatiquement
Interprétation algorithmique
Classification scientifique multi-axes
ne pas confondre statut et résultatÉtat de l’étudeRecrutement en cours
Disponibilité des résultatsRésultats à vérifier
InterprétationImpossible à déterminer
Niveau de preuveNon évaluable
Un essai terminé n’est pas nécessairement positif. Un essai arrêté n’est classé comme échec scientifique que lorsqu’un résultat ou une raison explicite le confirme.
Indicateurs factuels
sans score subjectifPhase enregistréeNon applicable
Études associées5
Publications associées6
Statut consolidéSuivi actif
Aucune chance de succès, note d’innovation, potentiel thérapeutique ou probabilité de commercialisation n’est calculé tant qu’un modèle validé et des données suffisantes ne sont pas disponibles.
Historique factuel de la molécule
22 événement(s) daté(s)Cette liste reprend uniquement les dates trouvées dans les registres et publications liés. Elle ne constitue pas une prévision.
| Date | Événement | Source |
|---|---|---|
| 2023-07-13 | Début de l’étudeNCT05836987 | Registre d’essai clinique |
| 2024-05-01 | Début de l’étudeNCT05976685 | Registre d’essai clinique |
| 2024-09-26 | Début de l’étudeNCT06320431 | Registre d’essai clinique |
| 2025-09-24 | Début de l’étudeNCT07139314 | Registre d’essai clinique |
| 2026-07-14 | PublicationPharmacovigilance Analysis of Bleeding Events Associated With Selective Serotonin Reuptake Inhibitors (SSRIs) Using the US Food and Drug Administration Adverse Event Reporting System (FAERS). | Cureus |
| 2026-07-18 | PublicationRisk of immediate and delayed intracranial hemorrhage after minor head trauma: DOACs vs warfarin vs no anticoagulation. | The American journal of emergency medicine |
| 2026-07-23 | PublicationAntithrombotic Drug Eruptions in Dermatology Practice: Selection Bias, Clinical Phenotypes, and Diagnostic Approaches. | Cureus |
| 2026-08-08 | PublicationAspirin for Venous Thromboembolism Prevention in Orthopaedic Surgery with Focus on Trauma and Arthroplasty: A Structured Evidence-Based Review of Randomised Trials, Guidelines, and Contemporary Practice Considerations. | Journal of clinical medicine |
| 2026-08-08 | PublicationTelmisartan, P-glycoprotein inhibition, and bleeding risk in DOAC-treated patients with atrial fibrillation. | Hypertension research : official journal of the Japanese Society of Hypertension |
| 2026-08-13 | PublicationAnticoagulation Stewardship in the Era of Practice-Changing Evidence: A Narrative Review of Recent Trials and Their Bedside Translation. | Journal of clinical medicine |
| 2026-10-01 | Début de l’étudeNCT07899788 | Registre d’essai clinique |
| 2026-10-18 | Création de l’enregistrementNCT07139314 | Registre d’essai clinique |
| 2026-10-18 | Création de l’enregistrementNCT05836987 | Registre d’essai clinique |
| 2026-10-25 | Création de l’enregistrementNCT06320431 | Registre d’essai clinique |
| 2026-11-01 | Création de l’enregistrementNCT07899788 | Registre d’essai clinique |
| 2026-11-05 | Dernière mise à jour des donnéesDOAC | Biomedical Watch |
| 2026-11-08 | Création de l’enregistrementNCT05976685 | Registre d’essai clinique |
| 2026-11-30 | Fin de l’étude prévue / enregistréeNCT07139314 | Registre d’essai clinique |
| 2028-06-01 | Fin de l’étude prévue / enregistréeNCT05976685 | Registre d’essai clinique |
| 2029-07-31 | Fin de l’étude prévue / enregistréeNCT05836987 | Registre d’essai clinique |
| 2030-08-31 | Fin de l’étude prévue / enregistréeNCT07899788 | Registre d’essai clinique |
| 2030-12-31 | Fin de l’étude prévue / enregistréeNCT06320431 | Registre d’essai clinique |
Début phase actuelle
Non disponible dans les sources synchronisées
Essais cliniques liés
5 essai(s)
Début phase actuelle
Non disponible dans les sources synchronisées
| NCT | Titre | Phase | Statut administratif | Pays | Sponsor |
|---|---|---|---|---|---|
| NCT05976685 | ELAPSE — Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy | Non applicable | RECRUITING | Belgium, Germany, New Zealand, Spain, Switzerland, United Kingdom | Insel Gruppe AG, University Hospital Bern |
| NCT07899788 | CATCH-AF — CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke | Non applicable | NOT_YET_RECRUITING | Austria | Medical University of Graz |
| NCT06320431 | ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632 | Phase 3 | RECRUITING | Australia, Canada | University of Calgary |
| NCT07139314 | TIMERS-2 — Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation 2 | Non applicable | RECRUITING | China | Capital Medical University |
| NCT05836987 | REACT-AF — The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation | Phase 3 | RECRUITING | United States | Johns Hopkins University |
Publications liées
6 publication(s)Publications liées
6 publication(s)| Titre | PMID | DOI | Journal | Date |
|---|---|---|---|---|
| Anticoagulation Stewardship in the Era of Practice-Changing Evidence: A Narrative Review of Recent Trials and Their Bedside Translation. Voir source | 42590048 | 10.3390/jcm15155946 | Journal of clinical medicine | |
| Aspirin for Venous Thromboembolism Prevention in Orthopaedic Surgery with Focus on Trauma and Arthroplasty: A Structured Evidence-Based Review of Randomised Trials, Guidelines, and Contemporary Practice Considerations. Voir source | 42355718 | 10.3390/jcm15124550 | Journal of clinical medicine | |
| Telmisartan, P-glycoprotein inhibition, and bleeding risk in DOAC-treated patients with atrial fibrillation. Voir source | 42557440 | 10.1038/s41440-026-02758-7 | Hypertension research : official journal of the Japanese Society of Hypertension | |
| Antithrombotic Drug Eruptions in Dermatology Practice: Selection Bias, Clinical Phenotypes, and Diagnostic Approaches. Voir source | 42465709 | 10.7759/cureus.112751 | Cureus | |
| Risk of immediate and delayed intracranial hemorrhage after minor head trauma: DOACs vs warfarin vs no anticoagulation. Voir source | 42468197 | 10.1016/j.ajem.2026.07.006 | The American journal of emergency medicine | |
| Pharmacovigilance Analysis of Bleeding Events Associated With Selective Serotonin Reuptake Inhibitors (SSRIs) Using the US Food and Drug Administration Adverse Event Reporting System (FAERS). Voir source | 42403772 | 10.7759/cureus.110163 | Cureus |
Sources officielles
liens de rechercheDernière mise à jour des données : 2026-11-05
Ces sources sont proposées pour vérification. Les informations de la fiche doivent être confirmées dans les registres officiels ou les publications originales.