Clinical trials of drugs targeting FXI or FXIa for patients with heart disease
| Clinical trial . | Study drug . | Comparator . | Primary end point . | Patient population . | Incidence of bleeding . |
|---|---|---|---|---|---|
| PACIFIC-AF | Asundexian | Apixaban | Major or CNMR bleeding (ISTH) out to 12 wk | At least 45 y nonvalvular atrial fibrillation, CHAD2DS2-VASc score ≥ 2 if male and ≥ 3 if female. | Asundexian 20 mg (1.2%)∗, Asundexian 50 mg (0.4%)∗ Apixaban 5 mg BID (2.4%) |
| PACIFIC-AMI | Asundexian | Placebo | BARC level 2, 3, or 5 bleeding out to 6 mo | At least 45 y, acute MI by clinical symptoms and elevated myocardial necrosis markers. | Asundexian 10 mg (7.6%)†, Asundexian 20 mg (8.1%)†, Asundexian 50 mg (10.5%)† Placebo (9.0%) |
| AZALEA-TIMI 71 | Abelacimab | Rivaroxaban | Major or CNMR bleeding (ISTH) (average follow-up, 21 mo) | At least 55 y, nonvalvular atrial fibrillation, and a moderate-to-high risk of embolic stroke. | Abelacimab 90 mg (1.9/100 patient years)‡, Abelacimab 150 mg (2.7/100 patient years)‡ Rivaroxaban 20 mg/d (8.1/100 patient years) |
| Clinical trial . | Study drug . | Comparator . | Primary end point . | Patient population . | Incidence of bleeding . |
|---|---|---|---|---|---|
| PACIFIC-AF | Asundexian | Apixaban | Major or CNMR bleeding (ISTH) out to 12 wk | At least 45 y nonvalvular atrial fibrillation, CHAD2DS2-VASc score ≥ 2 if male and ≥ 3 if female. | Asundexian 20 mg (1.2%)∗, Asundexian 50 mg (0.4%)∗ Apixaban 5 mg BID (2.4%) |
| PACIFIC-AMI | Asundexian | Placebo | BARC level 2, 3, or 5 bleeding out to 6 mo | At least 45 y, acute MI by clinical symptoms and elevated myocardial necrosis markers. | Asundexian 10 mg (7.6%)†, Asundexian 20 mg (8.1%)†, Asundexian 50 mg (10.5%)† Placebo (9.0%) |
| AZALEA-TIMI 71 | Abelacimab | Rivaroxaban | Major or CNMR bleeding (ISTH) (average follow-up, 21 mo) | At least 55 y, nonvalvular atrial fibrillation, and a moderate-to-high risk of embolic stroke. | Abelacimab 90 mg (1.9/100 patient years)‡, Abelacimab 150 mg (2.7/100 patient years)‡ Rivaroxaban 20 mg/d (8.1/100 patient years) |
BARC, Bleeding Academic Research Consortium; BID, twice daily; CHAD2DS2-VASc, a scoring system that stratifies patients with stroke risk and atrial fibrillation. The acronym stands for congestive heart failure, hypertension, age ≥75 years (doubled), diabetes, stroke (doubled), vascular disease, age between 65 and 74 years, and sex (female); ISTH, International Society on Thrombosis and Haemostasis.
Significantly lower than apixaban 5 mg twice a day.
Not significantly different from placebo.
Significantly lower than rivaroxaban 20 mg/d (P < .0001).