WHO ICTRP trial
A multicenter, international, randomized, active comparator-controlled…
NL-OMON53820 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting
Key facts
| Trial ID | NL-OMON53820 |
|---|---|
| Public title | A multicenter, international, randomized, active comparator-controlled, double-blind, doubledummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor Asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke |
| Scientific title | A multicenter, international, randomized, active comparator-controlled, double-blind, doubledummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor Asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and… |
| Primary sponsor | Bayer |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Austria;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea (the Republic… |
| Conditions | atrial fibrillation heart arrhythmia;10007521 |
| Interventions | Asundexian is the sponsor*s study intervention under investigation. Apixaban is the intervention used as comparator. The following intervention groups are included in the study: · Asundexian · Apixaban |
| Registration date | Nov 7, 2022 |
| Target size | 400 |
| Secondary IDs | 2022-000758-28;NL82345.056.22 |
| Registry page | onderzoekmetmensen.nl |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: