Trials of drugs targeting FXIa for secondary prevention of ischemic stroke
| Clinical trial . | Study drug . | Patients . | Primary end point . | Patient population . | Incidence of bleeding . |
|---|---|---|---|---|---|
| PACIFIC-STROKE | Asundexian (10, 20, or 50 mg/d) compared with placebo | More than 45 y with acute noncardioembolic stroke | Symptomatic ischemic stroke or MRI-detected covert Infarct at 26 wks | Asundexian 10 mg (19%)∗, Asundexian 20 mg (22%)∗, Asundexian 50 mg (20%)∗ Placebo (19%) | Major or CRNM bleeding (ISTH) Asundexian 10 mg (4%) Asundexian 20 mg (3%) Asundexian 50 mg (4%) Placebo (2%) |
| AXIOMATIC-SSP | Milvexian (25 to 200 mg once or twice daily) compared with placebo | More than 40 y with acute ischemic stroke (<48 h) or high-risk TIA | Symptomatic ischemic stroke or MRI-detected covert Infarct at 90 weeks | Twice daily dosing: Milvexian 25 mg (18.5%)∗, Milvexian 50 mg (14.1%)∗, Milvexian 100 mg (14.8%)∗, Milvexian 200 mg (16.4%)∗ Placebo (16.1%) | BARC-modified 3 or 5 bleeding Milvexian 25 mg (0.6%) Milvexian 50 mg (1.5%) Milvexian 100 mg (1.6%) Milvexian 200 mg (1.5%) Placebo (1%) |
| Clinical trial . | Study drug . | Patients . | Primary end point . | Patient population . | Incidence of bleeding . |
|---|---|---|---|---|---|
| PACIFIC-STROKE | Asundexian (10, 20, or 50 mg/d) compared with placebo | More than 45 y with acute noncardioembolic stroke | Symptomatic ischemic stroke or MRI-detected covert Infarct at 26 wks | Asundexian 10 mg (19%)∗, Asundexian 20 mg (22%)∗, Asundexian 50 mg (20%)∗ Placebo (19%) | Major or CRNM bleeding (ISTH) Asundexian 10 mg (4%) Asundexian 20 mg (3%) Asundexian 50 mg (4%) Placebo (2%) |
| AXIOMATIC-SSP | Milvexian (25 to 200 mg once or twice daily) compared with placebo | More than 40 y with acute ischemic stroke (<48 h) or high-risk TIA | Symptomatic ischemic stroke or MRI-detected covert Infarct at 90 weeks | Twice daily dosing: Milvexian 25 mg (18.5%)∗, Milvexian 50 mg (14.1%)∗, Milvexian 100 mg (14.8%)∗, Milvexian 200 mg (16.4%)∗ Placebo (16.1%) | BARC-modified 3 or 5 bleeding Milvexian 25 mg (0.6%) Milvexian 50 mg (1.5%) Milvexian 100 mg (1.6%) Milvexian 200 mg (1.5%) Placebo (1%) |
BARC, Bleeding Academic Research Consortium; CRNM, clinically relevant nonmajor bleeding; TIA, transient ischemic attack
Not significantly different from results with placebo.