Phase III study to investigate the efficacy and safety of the oral FXIa inhibitor Asundexian (BAY 2433334) compared to placebo in participants after an acute non-cardioembolic ischemic stroke or a high-risk TIA (Transient Ischemic Attack)
Descrizione riassuntiva dello studio
The study drug Asundexian is a new anticoagulant. The drug is currently still in development to open up new treatment options. Its mechanism of action aims to improve the standard of care regarding bleeding risk. The main objective of this study is to investigate whether Asundexian, compared to placebo, in combination with standard therapy (here, so-called "antiplatelet agents"), can better prevent recurrent strokes than placebo. By "placebo," we mean a dummy drug that looks the same as the drug but contains no active ingredient. Another objective of the study is to investigate how many bleeding events occur with Asundexian compared to placebo. Major bleeding can seriously threaten health or even be life-threatening. The approximately 12,300 patients planned for treatment will be randomly assigned to either the Asundexian group or the placebo group. The therapy lasts a minimum of 3 months and a maximum of 31 months. Visits to the center or phone calls with the center are planned every 3 months during therapy. Throughout the study, all medical problems occurring in study participants will be recorded. All study participants will be asked to complete quality of life questionnaires several times during the study. After the end of therapy, one or two final visits to the center are still planned. This is for the safety of the study participants.
(BASEC)
Intervento studiato
In each case in addition to the standard therapy of a stroke with platelet inhibitors:
• Asundexian 50 mg tablet once daily.
• Placebo tablet 1 x daily.
(BASEC)
Malattie studiate
Prevention of strokes in patients who have had a stroke caused by a blood clot that has spread and formed outside the heart OR Prevention of stroke after transient stroke-like symptoms with high risk of developing into stroke
(BASEC)
- Study participants must be ≥ 18 years old - Acute stroke that is not due to one washed ashore by the heart blood clots or a so-called "high-risk TIA", i.e. temporary Stroke-like symptoms are at high risk of developing into a stroke to develop. - Systemic or cerebrovascular atherosclerosis or a so-called cerebral infarction of the large blood vessels - For the study participants, standard stroke therapy must be used be planned (BASEC)
Criteri di esclusione
- A stroke that occurred less than 7 days before the stroke that led to inclusion in the study - Stroke as a result of medical interventions or stroke due to others, rare causes - History of atrial fibrillation, blood clots in the left ventricle, mechanical heart valves, or other source of stroke initiating Clots, each requiring anticoagulant therapy. (BASEC)
Luogo dello studio
Basilea, Berna, Friburgo, Ginevra, Losanna, Lugano, San Gallo, Zurigo, Altro
(BASEC)
Baden (AG)
(BASEC)
Sponsor
Bayer AG, 51368 Leverkusen, Germany. Sponsor's representative in CH: Bayer (Schweiz) AG.
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Sophia Birnbaum
+41 44 465 81 11
clinical.operations.switzerland@clutterbayer.comBayer (Schweiz) AG Medical Departement Bayer Schweiz, Pharmaceuticals Clinical Research Grubenstrasse 8 CH-8045 Zurich
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Ethikkommission Ostschweiz EKOS
(BASEC)
Data di approvazione del comitato etico
02.02.2023
(BASEC)
ID di studio ICTRP
NCT05686070 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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. (BASEC)
Titolo accademico
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 (ICTRP)
Titolo pubblico
A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke (ICTRP)
Malattie studiate
Prevention of Ischemic StrokeAcute Non-cardioembolic Ischemic StrokeHigh-risk Transient Ischemic Attack (ICTRP)
Intervento studiato
Drug: Asundexian (BAY2433334)Drug: Placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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
Exclusion Criteria:
- 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 (ICTRP)
non disponibile
Endpoint primari e secondari
Time to first occurrence of ischemic stroke;Time to first occurrence of ISTH major bleeding (ICTRP)
Time to first occurrence of all strokes (ischemic and hemorrhagic);Time to first occurrence of composite of CV death, MI or stroke;Time to first occurrence of composite of all-cause mortality, MI or stroke;Time to first occurrence of disabling stroke (mRS =3 at 90 days);Time to first occurrence of all-cause mortality;Time to first occurrence of transient ischemic attack (TIA);Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding;Time to first occurrence of ISTH clinically relevant non-major bleeding;Time to first occurrence of symptomatic intracranial hemorrhage;Time to first occurrence of hemorrhagic stroke;Time to first occurrence of fatal bleeding;Time to first occurrence of minor bleeding;Time to first occurrence of composite of ischemic stroke or ISTH major bleeding;Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding;Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage;Time to first occurrence of ischemic stroke in the first 90 days (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Bayer Clinical Trials Contact, clinical-trials-contact@bayer.com, (+)1-888-84 22937 (ICTRP)
ID secondari
2023-503793-20-00, 2022-001067-27, 20604 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT05686070 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile