Informations générales (source: ClinicalTrials.gov)
A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA (OCEANIC-STROKE)
Interventional
Phase 3
Bayer (Voir sur ClinicalTrials)
janvier 2023
octobre 2025
14 décembre 2024
Researchers are looking for a better way to prevent an ischemic stroke which occurs when
a blood clot travelled to the brain in people who within the last 72 hours had:
- an acute stroke due to a blood clot that formed outside the heart (acute
non-cardioembolic ischemic stroke), or
- TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient
ischemic attack), and who are planned to receive standard of care therapy. Acute
ischemic strokes or TIA/mini-stroke result from a blocked or reduced blood flow to a
part of the brain. They are caused by blood clots that travel to the brain and block
the vessels that supply it. If these blood clots form elsewhere than in the heart,
the stroke is called non-cardioembolic. People who already had a non-cardioembolic
stroke are more likely to have another stroke. This is why they are treated
preventively with an antiplatelet therapy, the current standard of care.
Antiplatelet medicines prevent platelets, components of blood clotting, from
clumping together.
Anticoagulants are another type of medicine that prevents blood clots from forming by
interfering with a process known as coagulation (or blood clotting).
The study treatment asundexian is a new type of anticoagulant currently under development
to provide further treatment options. Asundexian aims to further improve the standard of
care without increasing the risk of bleeding.
The main purpose of this study is to learn whether asundexian works better than placebo
at reducing ischemic strokes in participants who recently had a non-cardioembolic
ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet
therapy. A placebo is a treatment that looks like a medicine but does not have any
medicine in it.
Another aim is to compare the occurrence of major bleeding events during the study
between the asundexian and the placebo group. Major bleedings have a serious or even
life-threatening impact on a person's health.
Dependent on the treatment group, the participants will either take asundexian or placebo
once a day for at least 3 months up to 31 months.
Approximately every 3 months during the treatment period, either a phone call or a visit
to the study site is scheduled on an alternating basis. In addition, one visit before and
up to two visits after the treatment period are planned.
During the study, the study team will:
- Check vital signs such as blood pressure and heart rate
- Examine the participants' heart health using an electrocardiogram (ECG)
- Take blood samples
- Ask the participants questions about how they are feeling and what adverse events
they are having.
An adverse event is any medical problem that a participant has during a study. Doctors
keep track of all adverse events that happen in studies, even if they do not think the
adverse events might be related to the study treatments. In addition, the participants
will be asked to complete a questionnaire on quality of life at certain time points
during the study.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GHU PARIS PSY ET NEUROSCIENCES | Michaël OBADIA | 12/06/2024 04:28:25 | Contacter | ||
| HOPITAL FOCH | David Weisenburger-lile | 23/12/2024 08:04:35 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Michaël OBADIA | 21/06/2024 13:35:01 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Bicêtre | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Raymond Poincaré | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier - Le Mans - 72037 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| CH Boulogne-Sur-Mer - Neurologie - 62321 - Boulogne-sur-mer - France | Contact (sur clinicalTrials) | ||||
| CH Sud Francilien, Neurologie - 91100 - Corbeil-essonnes - France | Contact (sur clinicalTrials) | ||||
| CHU Dijon, Neurologie - 21079 - DIJON Cedex - France | Contact (sur clinicalTrials) | ||||
| CHU STRASBOURG - Hôpital de Hautepierre - 67200 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| H bretonneau, neurologie, Tours - 37044 - TOURS cedex 9 - France | Contact (sur clinicalTrials) | ||||
| H Maison Blanche, Neurologie, REIMS - 51092 - Reims - France | Contact (sur clinicalTrials) | ||||
| Hôpital B - Lille - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hopital Carémeau - Nîmes - 30029 - Nîmes - France | Contact (sur clinicalTrials) | ||||
| Hopital Central - Nancy - 54037 - Nancy - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Pitié-Salpétrière - 75634 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hopital des Armees Sainte-Anne, Neurologie, Toulon - 83800 - Toulon cedex 09 - France | Contact (sur clinicalTrials) | ||||
| Hôpital Guillaume et René Laennec - Nantes - 44035 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hopital Jean Minjoz - 25030 - Besancon - France | Contact (sur clinicalTrials) | ||||
| Hôpital La Cavale Blanche - CHU de Brest - 29609 - Brest Cedex - France | Contact (sur clinicalTrials) | ||||
| Hôpital Lariboisière - Paris - 75475 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pasteur - Nice - 6200 - Nice - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pellegrin - Bordeaux - 33076 - BORDEAUX cedex - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pontchaillou - 35033 - Rennes Cedex - France | Contact (sur clinicalTrials) | ||||
| Hôpital Purpan - Toulouse - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Hôpital Rothschild - Paris - 75019 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Philibert - Service de Neurologie - 59462 - LOMME cedex - France | Contact (sur clinicalTrials) | ||||
| Hôpital Wertheimer - Lyon - 69003 - Lyon - France | Contact (sur clinicalTrials) | ||||
| La Timone, Neurologie, MARSEILLE - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Participants must be ≥ 18 years of age
- Acute non-cardioembolic stroke or high-risk TIA
- Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
- Participants must be ≥ 18 years of age
- Acute non-cardioembolic stroke or high-risk TIA
- Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
- Ischemic stroke ≤ 7 days before the index event
- Index stroke following procedures or strokes due to other rare causes
- History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or
other cardioembolic source of stroke requiring anticoagulation