[Translation] A phase III, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of the oral factor XIa inhibitor Milvexian compared with apixaban in subjects with atrial fibrillation
1.根据“卒中和非中枢神经系统(CNS)系统性体循环栓塞” 复合终点,评估Milvexian是否非劣效于阿哌沙班。 2. 评价Milvexian在降低系列主要安全性终点风险方面是否优于阿哌沙班:
·ISTH大出血
·“ISTH大出血和CRNM出血”复合终点
3. 根据“CV死亡、MI、卒中和非CNS系统性栓塞”复合终点,评价Milvexian是否优于阿哌沙班。
4. 根据CV死亡,评价Milvexian是否优于阿哌沙班。
5. 根据“全因死亡、MI、卒中和非CNS系统性栓塞”复合终点,评价Milvexian是否优于阿哌沙班。
6.根据由以下各项构成的复合终点,评价Milvexian是否优于阿哌沙班:CV死亡、MI、卒中、任何非预期的血运重建术(包括缺血性肢体截肢)和因缺血性血管原因而紧急住院(包括血栓形成事件:深静脉血栓形成[DVT]和肺栓塞[PE])。
[Translation] 1. To evaluate whether Milvexian is non-inferior to apixaban based on the composite endpoint of "stroke and non-central nervous system (CNS) systemic systemic embolism". 2. Evaluate whether Milvexian is superior to apixaban in reducing the risk of a series of primary safety endpoints:
·ISTH massive bleeding
·Composite endpoint of "ISTH major bleeding and CRNM bleeding"
3. Evaluate whether Milvexian is better than apixaban based on the composite endpoint of "CV death, MI, stroke and non-CNS systemic embolism".
4. Evaluate whether Milvexian is superior to apixaban based on CV mortality.
5. Evaluate whether Milvexian is better than apixaban based on the composite endpoint of "all-cause death, MI, stroke and non-CNS systemic embolism".
6. Evaluate whether Milvexian is superior to apixaban based on a composite endpoint of CV death, MI, stroke, any unanticipated revascularization (including ischemic limb amputation), and Emergency hospitalization for vascular reasons (including thrombotic events: deep vein thrombosis [DVT] and pulmonary embolism [PE]).