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. 2014 Apr 16;19(4):299–302. doi: 10.1111/anec.12164

Table 1.

Efficacy of Intravenous Vernakalant in Randomized Clinical Trials

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.