Ongoing landmark randomized controlled trials on FXI/FXIa inhibitors in atrial fibrillation.
| Study . | Sample size (estimated) . | Study design . | Intervention . | Control . | Primary endpoint . |
|---|---|---|---|---|---|
| LILAC-TIMI 76 (NCT05712200) | 1900 | Phase 3 | Abelacimab 150 mg monthly subcutaneously | Placebo | Efficacy: time to first ischaemic stroke or SE. Safety: time to first occurrence of bleeding type 3c/5 according to BARC |
| OCEANIC-AFINA (2023-505421-13) | 2000 | Phase 3 | Asundexian 50 mg once a day orally | Placebo | Efficacy: time to first ischaemic stroke or SE. Safety: time to first occurrence of major bleeding according to ISTH |
| LIBREXIA-AF (NCT05757869) | 15 500 | Phase 3 | Milvexian 100 mg twice daily orally | Apixaban 5 mg or 2.5 mg twice daily, according to dose-reduction criteria | Time to first occurrence of composite stroke and SE not involving the central nervous system |
| Study . | Sample size (estimated) . | Study design . | Intervention . | Control . | Primary endpoint . |
|---|---|---|---|---|---|
| LILAC-TIMI 76 (NCT05712200) | 1900 | Phase 3 | Abelacimab 150 mg monthly subcutaneously | Placebo | Efficacy: time to first ischaemic stroke or SE. Safety: time to first occurrence of bleeding type 3c/5 according to BARC |
| OCEANIC-AFINA (2023-505421-13) | 2000 | Phase 3 | Asundexian 50 mg once a day orally | Placebo | Efficacy: time to first ischaemic stroke or SE. Safety: time to first occurrence of major bleeding according to ISTH |
| LIBREXIA-AF (NCT05757869) | 15 500 | Phase 3 | Milvexian 100 mg twice daily orally | Apixaban 5 mg or 2.5 mg twice daily, according to dose-reduction criteria | Time to first occurrence of composite stroke and SE not involving the central nervous system |
BARC, Bleeding Academic Research Consortium; ISTH, International Society on Thrombosis and Haemostasis; SE, systemic embolism; LILAC-TIMI 76, Study to Evaluate the Efficacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation; OCEANIC-AFINA, Oral FXIa Inhibitor Asundexian in Patients with Atrial Fibrillation Ineligible for Oral Anticoagulant Treatment; LIBREXIA-AF, A Study of Milvexian Versus Apixaban in Participants with Atrial Fibrillation.
Ongoing landmark randomized controlled trials on FXI/FXIa inhibitors in atrial fibrillation.
| Study . | Sample size (estimated) . | Study design . | Intervention . | Control . | Primary endpoint . |
|---|---|---|---|---|---|
| LILAC-TIMI 76 (NCT05712200) | 1900 | Phase 3 | Abelacimab 150 mg monthly subcutaneously | Placebo | Efficacy: time to first ischaemic stroke or SE. Safety: time to first occurrence of bleeding type 3c/5 according to BARC |
| OCEANIC-AFINA (2023-505421-13) | 2000 | Phase 3 | Asundexian 50 mg once a day orally | Placebo | Efficacy: time to first ischaemic stroke or SE. Safety: time to first occurrence of major bleeding according to ISTH |
| LIBREXIA-AF (NCT05757869) | 15 500 | Phase 3 | Milvexian 100 mg twice daily orally | Apixaban 5 mg or 2.5 mg twice daily, according to dose-reduction criteria | Time to first occurrence of composite stroke and SE not involving the central nervous system |
| Study . | Sample size (estimated) . | Study design . | Intervention . | Control . | Primary endpoint . |
|---|---|---|---|---|---|
| LILAC-TIMI 76 (NCT05712200) | 1900 | Phase 3 | Abelacimab 150 mg monthly subcutaneously | Placebo | Efficacy: time to first ischaemic stroke or SE. Safety: time to first occurrence of bleeding type 3c/5 according to BARC |
| OCEANIC-AFINA (2023-505421-13) | 2000 | Phase 3 | Asundexian 50 mg once a day orally | Placebo | Efficacy: time to first ischaemic stroke or SE. Safety: time to first occurrence of major bleeding according to ISTH |
| LIBREXIA-AF (NCT05757869) | 15 500 | Phase 3 | Milvexian 100 mg twice daily orally | Apixaban 5 mg or 2.5 mg twice daily, according to dose-reduction criteria | Time to first occurrence of composite stroke and SE not involving the central nervous system |
BARC, Bleeding Academic Research Consortium; ISTH, International Society on Thrombosis and Haemostasis; SE, systemic embolism; LILAC-TIMI 76, Study to Evaluate the Efficacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation; OCEANIC-AFINA, Oral FXIa Inhibitor Asundexian in Patients with Atrial Fibrillation Ineligible for Oral Anticoagulant Treatment; LIBREXIA-AF, A Study of Milvexian Versus Apixaban in Participants with Atrial Fibrillation.
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