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

Phase 1

• Conditions: Prevention of stroke or systemic embolism in atrial fibrillation; MedDRA version: 20.0Level: PTClassification code 10049165Term: Cerebrovascular accident prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: LLTClassification code 10049910Term: Thromboembolism prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2022-000758-28-CZ
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-01
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18000

Inclusion Criteria

1. 18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent
2. Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant
3. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12000

Exclusion Criteria

1. Mechanical heart valve prosthesis
2. Moderate-to-severe mitral stenosis at the time of inclusion into the study
3. Atrial fibrillation only due to reversible cause
4. Requirement for chronic anticoagulation for a different indication than atrial fibrillation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified