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)
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
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)
Exclusion criteria
- 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)
Trial sites
Basel, Bern, Freiburg, Geneva, Lausanne, Lugano, St. Gallen, Zurich, Other
(BASEC)
Baden (AG)
(BASEC)
Sponsor
Bayer AG, 51368 Leverkusen, Germany. Sponsor's representative in CH: Bayer (Schweiz) AG.
(BASEC)
Contact
Contact Person Switzerland
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)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
02.02.2023
(BASEC)
ICTRP Trial ID
NCT05686070 (ICTRP)
Official title (approved by ethics committee)
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)
Academic title
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)
Public title
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)
Disease under investigation
Prevention of Ischemic StrokeAcute Non-cardioembolic Ischemic StrokeHigh-risk Transient Ischemic Attack (ICTRP)
Intervention under investigation
Drug: Asundexian (BAY2433334)Drug: Placebo (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Bayer Clinical Trials Contact, clinical-trials-contact@bayer.com, (+)1-888-84 22937 (ICTRP)
Secondary trial IDs
2023-503793-20-00, 2022-001067-27, 20604 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT05686070 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available