Trial Outcomes & Findings for Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm (NCT NCT02454283)
NCT ID: NCT02454283
Last Updated: 2016-10-17
Results Overview
Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
41 participants
Primary outcome timeframe
24 hours
Results posted on
2016-10-17
Participant Flow
Participant milestones
| Measure |
Vanoxerine HCl
Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Vanoxerine HCl
|
Placebo
identically matching placebo capsules, orally, single-dose
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
15
|
|
Overall Study
COMPLETED
|
26
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
Baseline characteristics by cohort
| Measure |
Vanoxerine HCl
n=26 Participants
Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Vanoxerine HCl
|
Placebo
n=15 Participants
identically matching placebo capsules, orally, single-dose
Placebo
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
66.9 years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
67.7 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Prior AF/AFL
|
16 participants
n=99 Participants
|
7 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Hypertension
|
16 participants
n=99 Participants
|
11 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Diabetes mellitus
|
4 participants
n=99 Participants
|
0 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Hyperlipidemia
|
8 participants
n=99 Participants
|
6 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
COPD
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Hyperthyroidism
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Hypothyroidism
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Prior stroke
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Pacemaker
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Heart failure
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
LVEF, mean
|
54.3 %
STANDARD_DEVIATION 8.4 • n=99 Participants
|
55.1 %
STANDARD_DEVIATION 12.4 • n=107 Participants
|
54.6 %
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
Mitral stenosis
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Mitral regurgitation
|
10 participants
n=99 Participants
|
4 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Aortic stenosis
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Aortic regurgitation
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Ischemic heart disease
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Prior revascularization (PCI or CABG)
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Prior antiarrhythmic drug therapy
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Prior catheter ablation of AF
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Aspirin
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Warfarin
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Non vitamin K antagonist
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Other anticoagulant
|
11 participants
n=99 Participants
|
3 participants
n=107 Participants
|
14 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hoursConversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.
Outcome measures
| Measure |
Vanoxerine HCl
n=26 Participants
Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Vanoxerine HCl
|
Placebo
n=15 Participants
identically matching placebo capsules, orally, single-dose
Placebo
|
|---|---|---|
|
Conversion to Sinus Rhythm
|
18 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 8 daysOutcome measures
| Measure |
Vanoxerine HCl
n=20 Participants
Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Vanoxerine HCl
|
Placebo
n=12 Participants
identically matching placebo capsules, orally, single-dose
Placebo
|
|---|---|---|
|
Length of Stay (From Time of Study Drug Administration)
|
4.7 days
Standard Deviation 3.2
|
4.2 days
Standard Deviation 2.9
|
Adverse Events
Vanoxerine HCl
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vanoxerine HCl
n=26 participants at risk
Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Vanoxerine HCl
|
Placebo
n=15 participants at risk
identically matching placebo capsules, orally, single-dose
Placebo
|
|---|---|---|
|
Cardiac disorders
polymorphic ventricular tachycardia
|
11.5%
3/26 • Number of events 3
|
0.00%
0/15
|
|
Cardiac disorders
torsades de pointes
|
3.8%
1/26 • Number of events 1
|
0.00%
0/15
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place