Table 1.
CRAFT | ACT I | ACT II | ACT III | ACT IV | AVRO | Scene 2 | |
---|---|---|---|---|---|---|---|
Type | RCT/phase II | RCT/phase III | RCT/phase III | RCT/phase III | Open label | RCT | RCT/phase II/III |
Inclusion criteria | AF for 3–72 h | AF for 3 h to 45 d | Postoperative AF/AFL for 3 h to 3 d | AF for 3 h to 45 d | AF for 3 h to 45 d | AF for 3 to 48 h | AFL for 3 h to 45 d |
Follow‐up | 24 h | 24 h | 7 d | 24 h | 7 d | 24 h | 30 d |
Patients, n | 56 | 336 | 161 | 276 | 236 | 254 | 54 |
Primary efficacy endpoint | AF termination within 30 min: 61% (V) vs 5% (P) (P < 0.0005) | AF (3 h to 7 d) termination within 90 min: 51.7% (V) vs 4.0% (P) (P < 0.001); median time to conversion to SR: 11 min; patients in SR at 24 h: 98% | AF/AFL termination within 90 min: 45% (V) vs 15% (P) (P < 0.001); AF termination within 90 min: 47% (V) vs 14% (P) (P < 0.001); no conversion of AFL to SR: 0/6 patients given V | AF (3 h to 7 d) termination within 90 min: 51.2% (V) vs 3.6% (P) (P < 0.001). AF (8–45 d) termination within 90 min: 9.4% (V) vs 2.7% (P) (P = NS). Patients in SR at 24 h: 98% (V) | AF (3 h to 7 d) termination within 90 min by V: 50.9%; median time to conversion to SR: 14 min; patients in SR at 24 h and 7 days: 98% and 89% of responders | AF termination within 90 min: 51.7% (V) vs 5.2% (A) (P < 0.0001) | AFL conversion within 90 min: 3% (V) vs 0% (P) (P = NS) |
A, amiodarone; ACT, atrial arrhythmia conversion trial; AVRO, a phase III superiority study of vernakalant vs amiodarone in subjects with recent onset atrial fibrillation; CRAFT, conversion of rapid atrial fibrillation trial; d, days; h, hours; min, minutes; NS, not significant; RCT, randomized controlled trial; P, placebo; SR, sinus rhythm; V, vernakalant.