A study to learn how well the study treatment asundexian works and how safe it is compared to apixaban to prevent strokeor systemic embolism in people with irregular and often rapid heartbeat (atrial fibrillation), and at risk for stroke

Phase 3

Conditions: Chronic atrial fibrillation. Ayurveda Condition: Atrial Fibrillation,

Brief Summary: Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with increased rates of death, stroke and other thromboembolic events.

Current treatment guidelines recommend the use of long-term oral anticoagulant therapy such as VKAs, or NOACs in patients with AF at risk for stroke.

This pivotal Phase 3 study will evaluate the efficacy and safety of asundexian compared with apixaban for the prevention of stroke or systemic embolism in participants with atrial fibrillation.

Asundexian, as an oral FXIa inhibitor, is expected to show a benefit in reducing the risk for stroke or systemic embolism in patients with AF in Phase 3.

Asundexian is therefore an attractive candidate to be evaluated as a potential replacement for NOAC therapy in patients with AF.

In conclusion, asundexian is believed to represent a potentially improved new therapeutic option for thrombosis prevention in life-threatening thrombotic diseases with superior bleeding safety compared to oral anticoagulants and without a significant increase in bleeding risk on top of available antiplatelet therapy.

Recruitment & Eligibility

Inclusion Criteria

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 â‰¥ 3 if male or â‰¥ 4 if female, OR CHA2DS2-VASc score of 2 if male or 3 if female and enrichment criteria.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Time to first occurrence of composite of stroke or systemic embolism	Up to 34 months

Secondary Outcome Measures

Name	Time	Method
Time to first occurrence of cardiovascular (CV) death	Up to 34 months
Time to first occurrence of composite of CV death, stroke, or myocardial infarction	Up to 34 months
Time to first occurrence of composite of ischemic stroke or systemic embolism	Up to 34 months
Time to first occurrence of all-cause mortality	Up to 34 months
Time to first occurrence of ischemic stroke	Up to 34 months
Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding	Up to 34 months
Time to first occurrence of clinically relevant non-major bleeding	Up to 34 months
Time to first occurrence of hemorrhagic stroke	Up to 34 months
Time to first occurrence of intracranial hemorrhage	Up to 34 months
Time to first occurrence of fatal bleeding	Up to 34 months
Time to first occurrence of minor bleeding	Up to 34 months
Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortality	Up to 34 months
Time to first occurrence of composite of disabling stroke (modified Rankin Scale (mRS) â‰¥ 3), critical bleeding, or all-cause mortality	Up to 34 months

Locations (6): IPGMER and SSKM Hospital
🇮🇳
Kolkata, WEST BENGAL, India
KEM Hospital and Research Center
🇮🇳
Pune, MAHARASHTRA, India
Lisie Hospital
🇮🇳
Ernakulam, KERALA, India
Shri B D Mahavir Heart Institute
🇮🇳
Surat, GUJARAT, India
Sir Ganga Ram Hospital
🇮🇳
East, DELHI, India
Vijan Hospital and Research Center
🇮🇳
Nashik, MAHARASHTRA, India
IPGMER and SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
Dr Sankar Chandra Mondal
Principal investigator
9433009582
drscmandal5@gmail.com