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NCT05643573 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke
A Phase 3 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 14,830
- Enrollment target
NCT05643573 is a Phase 3 study that was terminated before completion, run by Bayer. The registered enrollment target is 14,830 participants.
The verdict
NCT05643573, a Phase 3 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 14,830 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat people with atrial fibrillation (AF) and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel). Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding. 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 with regard to the risk of bleeding. The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke. To see how well the study treatment asundexian works researchers compare: * how long asundexian works well and * how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening: * stroke and/or * systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study. To see how safe asundexian
Interventions
- DRUG Apixaban
- DRUG Asundexian (BAY2433334)
- DRUG Asundexian matching placebo
- DRUG Apixaban matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,830 participants |
| Start Date | 2022-12-05 |
| Est. Completion | 2024-01-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05643573
The ClinicalTrials.gov registry entry for NCT05643573 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 14,830 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Apixaban is the first listed.
NCT05643573 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05643573 about?
NCT05643573 is a clinical study titled "A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke". Researchers are looking for a better way to treat people with atrial fibrillation (AF) and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel). Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to t...
What is the current status of trial NCT05643573?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 14,830 participants. The study started on 2022-12-05. Estimated completion is 2024-01-31.
What interventions are being tested in trial NCT05643573?
The interventions under investigation include: Apixaban (DRUG), Asundexian (BAY2433334) (DRUG), Asundexian matching placebo (DRUG), Apixaban matching placebo (DRUG).
Who is sponsoring clinical trial NCT05643573?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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