Trial Outcomes & Findings for New Formulations of Propafenone to Treat Atrial Fibrillation (NCT NCT02710669)
NCT ID: NCT02710669
Last Updated: 2022-06-03
Results Overview
A rapid atrial pacing protocol was used to attempt to induce atrial fibrillation/atrial flutter. Twenty minutes after start of the study drug, participants underwent placement of a decapolar coronary sinus catheter. Pacing was performed from the proximal electrode at 20 milliamps and a pulse width of 2 ms. Bursts from the CS proximal electrode were induced to attempt atrial fibrillation.
TERMINATED
PHASE1/PHASE2
193 participants
Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)
2022-06-03
Participant Flow
193 participants were enrolled. 1 participant withdrew consent prior to randomization.
Participant milestones
| Measure |
(R)-Propafenone
Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes
(R)-propafenone
|
(S)-Propafenone
Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes
(S)-Propafenone
|
Placebo
Placebo (normal saline) is infused over 10 minutes
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
86
|
21
|
|
Overall Study
COMPLETED
|
71
|
75
|
19
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
2
|
Reasons for withdrawal
| Measure |
(R)-Propafenone
Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes
(R)-propafenone
|
(S)-Propafenone
Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes
(S)-Propafenone
|
Placebo
Placebo (normal saline) is infused over 10 minutes
Placebo
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
|
Overall Study
Institutional delays (including COVID)
|
2
|
2
|
0
|
|
Overall Study
arrived in afib/aflutter
|
10
|
8
|
2
|
Baseline Characteristics
New Formulations of Propafenone to Treat Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
(R)-Propafenone
n=85 Participants
Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes
(R)-propafenone
|
(S)-Propafenone
n=86 Participants
Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes
(S)-Propafenone
|
Placebo
n=21 Participants
Placebo (normal saline) is infused over 10 minutes
Placebo
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=99 Participants
|
64 years
n=107 Participants
|
59 years
n=206 Participants
|
63 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
81 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
111 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
192 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
187 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=99 Participants
|
86 participants
n=107 Participants
|
21 participants
n=206 Participants
|
192 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)Population: 27 Participants not analyzed as follows: R GROUP: (1) prolonged pharmacy time compounding the study med; (8) arrived in atrial fib/flutter; (1) physician withdrew due to PAC's; (1) took antiarrhythmic prior to ablation; (1) difficult anatomy (1) ischemia on MRI; (1) Due to COVID the lab halted elective research. S GROUP: (7) arrived in afib; (1) clot on TEE; (1) elevated anxiety in patient; (1) procedure scheduled late in day; (1) cardiac cath work-up needed. PLACEBO GROUP: (2) arrived in afib
A rapid atrial pacing protocol was used to attempt to induce atrial fibrillation/atrial flutter. Twenty minutes after start of the study drug, participants underwent placement of a decapolar coronary sinus catheter. Pacing was performed from the proximal electrode at 20 milliamps and a pulse width of 2 ms. Bursts from the CS proximal electrode were induced to attempt atrial fibrillation.
Outcome measures
| Measure |
(R)-Propafenone
n=71 Participants
Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes
(R)-propafenone
|
(S)-Propafenone
n=75 Participants
Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes
(S)-Propafenone
|
Placebo
n=19 Participants
Placebo (normal saline) is infused over 10 minutes
Placebo
|
|---|---|---|---|
|
Number of Participants With Successful Induction of 30 Seconds of Atrial Fibrillation/Atrial Flutter
Sustained AF and/or AFL induced
|
60 Participants
|
60 Participants
|
12 Participants
|
|
Number of Participants With Successful Induction of 30 Seconds of Atrial Fibrillation/Atrial Flutter
Non-sustained AF and/or AFL induced
|
11 Participants
|
15 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)Population: 27 Participants not analyzed as follows: R GROUP: (1) prolonged pharmacy time compounding the study med; (8) arrived in atrial fib/flutter; (1) physician withdrew due to PAC's; (1) took antiarrhythmic prior to ablation; (1) difficult anatomy (1) ischemia on MRI; (1) Due to COVID the lab halted elective research. S GROUP: (7) arrived in afib; (1) clot on TEE; (1) elevated anxiety in patient; (1) procedure scheduled late in day; (1) cardiac cath work-up needed. PLACEBO GROUP: (2) arrived in afib
Inducibility of atrial fibrillation (AF) or atrial flutter (AFL) expressed as an ordinal variable based on stage of the induction protocol. * Stage 1 measured the AV block (Wenckebach) cycle length (AVBCL), AV node effective refractory period (AVN ERP) and atrial ERP (AERP). AVN ERP and AERP were measured at drive trains (S1) of 600 ms and 450 ms. Extrastimuli (S2) were introduced starting at a coupling interval of 500ms and decremented by 10ms with each pacing train. * Stage 2 consisted of 15-beat bursts from the CS proximal electrode. The starting cycle length was 250ms, which was decremented by 10ms with each burst. A 10-second rest period was used between bursts. Step 2 was complete when 1:1 atrial capture was lost or a minimum cycle length of 180ms was reached. Stage 3 consisted of 15-second bursts. The cycle length used for the bursts was the fastest cycle length achieved during Step 2 that maintained 1:1 atrial conduction.
Outcome measures
| Measure |
(R)-Propafenone
n=71 Participants
Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes
(R)-propafenone
|
(S)-Propafenone
n=75 Participants
Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes
(S)-Propafenone
|
Placebo
n=19 Participants
Placebo (normal saline) is infused over 10 minutes
Placebo
|
|---|---|---|---|
|
Number of Participants With Successful Inducibility of Atrial Fibrillation/Atrial Flutter Expressed as an Ordinal Variable Based on Stage of the Induction Protocol
Stage 1
|
5 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Successful Inducibility of Atrial Fibrillation/Atrial Flutter Expressed as an Ordinal Variable Based on Stage of the Induction Protocol
Stage 2
|
28 Participants
|
31 Participants
|
3 Participants
|
|
Number of Participants With Successful Inducibility of Atrial Fibrillation/Atrial Flutter Expressed as an Ordinal Variable Based on Stage of the Induction Protocol
Stage 3
|
27 Participants
|
24 Participants
|
8 Participants
|
|
Number of Participants With Successful Inducibility of Atrial Fibrillation/Atrial Flutter Expressed as an Ordinal Variable Based on Stage of the Induction Protocol
Non-inducible AF/AFL
|
11 Participants
|
15 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)Population: 27 Participants not analyzed as follows: R GROUP: (1) prolonged pharmacy time compounding the study med; (8) arrived in atrial fib/flutter; (1) physician withdrew due to PAC's; (1) took antiarrhythmic prior to ablation; (1) difficult anatomy (1) ischemia on MRI; (1) Due to COVID the lab halted elective research. S GROUP: (7) arrived in afib; (1) clot on TEE; (1) elevated anxiety in patient; (1) procedure scheduled late in day; (1) cardiac cath work-up needed. PLACEBO GROUP: (2) arrived in afib
A rapid atrial pacing protocol was used to attempt to induce atrial flutter. Twenty minutes after start of the study drug, participants underwent placement of a decapolar coronary sinus catheter. Pacing was performed from the proximal electrode at 20 milliamps and a pulse width of 2 ms. Bursts from the CS proximal electrode were induced to attempt atrial flutter.
Outcome measures
| Measure |
(R)-Propafenone
n=71 Participants
Single intravenous dose of (R)-propafenone (1mg/kg) infused over 10 minutes
(R)-propafenone
|
(S)-Propafenone
n=75 Participants
Single intravenous dose of (S)-propafenone (1mg/kg) infused over 10 minutes
(S)-Propafenone
|
Placebo
n=19 Participants
Placebo (normal saline) is infused over 10 minutes
Placebo
|
|---|---|---|---|
|
Number of Participants With Successful Induction of 30 Seconds of Atrial Flutter
Sustained AFL
|
23 Participants
|
26 Participants
|
1 Participants
|
|
Number of Participants With Successful Induction of 30 Seconds of Atrial Flutter
Non-Sustained AFL
|
48 Participants
|
49 Participants
|
18 Participants
|
Adverse Events
(R)-Propafenone
(S)-Propafenone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Benjamin Shoemaker, MD
Vanderbilt University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place