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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
EU CTIS ID: 2023-503794-38-00
What this study is testing
To demonstrate that asundexian is superior (at least non-inferior) when compared with apixaban for prevention of stroke and systemic embolism in participants with atrial fibrillation at risk for stroke. To demonstrate that asundexian is superior to apixaban as assessed by International Society on Thrombosis and Hemostasis (ISTH) major bleeding in participants with atrial fibrillation at risk for stroke. To demonstrate that asundexian is superior to apixaban with respect to benefit and risk.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent
- Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant
- CHA2DS2-VASc score >=3 if male or >= 4 if female, OR CHA2DS2-VASc score of 2 if male or 3 if female and enrichment criteria.
You likely can't join if
- Mechanical heart valve prosthesis
- Moderate-to-severe mitral stenosis at the time of inclusion into the study
- Atrial fibrillation only due to reversible cause
- Requirement for chronic anticoagulation for a different indication than atrial fibrillation
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Turkey
- Argentina
- United States
- Japan
- Korea, Republic of
- Israel
- Hong Kong
- New Zealand
- Colombia
- China
- Australia
- United Kingdom
- Brazil
- Malaysia
- Taiwan
- Switzerland
- Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Turkey; Argentina; United States; Japan; Korea, Republic of and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.