Trial Outcomes & Findings for Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery (NCT NCT00953212)
NCT ID: NCT00953212
Last Updated: 2018-04-26
Results Overview
Atrial fibrillation is a common complication of cardiac surgery which is associated with increased morbidity, length of stay and cost. The opportunity to use ascorbic acid for AF prophylaxis is attractive because of its low side effect profile, wide acceptance and low cost. This prospective, randomized trial used a 2 X 2 factorial design to determine whether prophylactic ascorbic acid alone, ascorbic acid with amiodarone, or amiodarone alone, when given along with beta blockers would decrease the incidence of postoperative AF in adult cardiac surgery when compared with beta blockers alone, all combinations failed to show any difference between the four groups. While there have been trials that have shown the addition of amiodarone to beta-blockers to be more effective, this analysis does not support that conclusion.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
5 postoperative days
Results posted on
2018-04-26
Participant Flow
Participant milestones
| Measure |
Beta Blockers, Ascorbic Acid and Amiodarone
beta blockers: metoprolol 25mg by mouth every 6 hours
amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively
ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days
|
Beta Blockers and Ascorbic Acid
Beta Blockers and Ascorbic Acid beta blockers: metoprolol 25mg by mouth every 6 hours
ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days
|
Beta Blockers and Amiodarone
Beta Blockers and Amiodarone
beta blockers: metoprolol 25mg by mouth every 6 hours
amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively
|
Beta Blockers Alone
Beta Blockers alone
beta blockers: metoprolol 25mg by mouth every 6 hours
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
76
|
74
|
78
|
76
|
|
Overall Study
COMPLETED
|
76
|
74
|
78
|
76
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Group A
n=76 Participants
Beta Blockers, Ascorbic Acid and Amiodarone
beta blockers: metoprolol 25mg by mouth every 6 hours
amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively
ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days
|
Group B
n=74 Participants
Beta Blockers and Ascorbic Acid
beta blockers: metoprolol 25mg by mouth every 6 hours
ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days
|
Group C
n=78 Participants
Beta Blockers and Amiodarone
beta blockers: metoprolol 25mg by mouth every 6 hours
amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively
|
Group D
n=76 Participants
Beta Blockers alone
beta blockers: metoprolol 25mg by mouth every 6 hours
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 931 • n=4 Participants
|
61 years
STANDARD_DEVIATION 15 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
230 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
302 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Smoker
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
BMI (mean, SD)
|
30.6 kg/m^2
STANDARD_DEVIATION 6.1 • n=5 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 5.7 • n=7 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 6.2 • n=4 Participants
|
29.7 kg/m^2
STANDARD_DEVIATION 5.8 • n=21 Participants
|
|
Cardiovascular Disease
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Hypertension
|
69 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
259 Participants
n=21 Participants
|
|
Pre-op Myocardial Infarction
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Diabetes
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Peripheral Vascular Disease
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Chronic Obstructive Pulmonary Disease
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Statin
|
54 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
203 Participants
n=21 Participants
|
|
Congestive Heart Failure
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Surgery Type - CABG
|
62 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
232 Participants
n=21 Participants
|
|
Surgery Type - Valve
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Surgery Type - CABG/Valve
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Surgery Type - Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Urgent Surgery
|
68 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
284 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 5 postoperative daysPopulation: Number of patients who experienced Atrial Fibrillation post-operatively
Atrial fibrillation is a common complication of cardiac surgery which is associated with increased morbidity, length of stay and cost. The opportunity to use ascorbic acid for AF prophylaxis is attractive because of its low side effect profile, wide acceptance and low cost. This prospective, randomized trial used a 2 X 2 factorial design to determine whether prophylactic ascorbic acid alone, ascorbic acid with amiodarone, or amiodarone alone, when given along with beta blockers would decrease the incidence of postoperative AF in adult cardiac surgery when compared with beta blockers alone, all combinations failed to show any difference between the four groups. While there have been trials that have shown the addition of amiodarone to beta-blockers to be more effective, this analysis does not support that conclusion.
Outcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
Occurrence of Post-operative Atrial Fibrillation Requiring Treatment After Open Heart Surgery
|
50 Participants
|
56 Participants
|
58 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 30 daysMortality measured within length of hospital stay
Outcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
Number of Participants With Mortality
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
Hospital Length of Stay
|
7.0 days
Standard Deviation 4.8
|
6.6 days
Standard Deviation 3.8
|
6.8 days
Standard Deviation 3.6
|
6.8 days
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
ICU Length of Stay
|
2.0 days
Standard Deviation 1.5
|
1.9 days
Standard Deviation 1.3
|
2.0 days
Standard Deviation 1.3
|
1.9 days
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 30 daysCerebral vascular accident occurring within hospital length of stay
Outcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
Number of Participants With Stroke
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
Number of Participants With Low Output Heart Failure
|
12 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
Number of Participants With Postoperative Vasoplegia
|
17 Participants
|
15 Participants
|
14 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
Number of Participants With Respiratory Failure Requiring Reintubation
|
4 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
Number of Participants With Bradycardia Necessitating Permanent Pacemaker Placement
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 daysUsing the Akin definition
Outcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
Number of Participants With Acute Kidney Injury
|
19 Participants
|
13 Participants
|
22 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
Number of Participants With Readmission to ICU for Treatment of Atrial Fibrillation
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Amiodarone - Yes
n=154 Participants
Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Amiodarone - No
n=150 Participants
Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
|
Ascorbic Acid - Yes
n=150 Participants
Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
Ascorbic Acid - No
n=154 Participants
Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
|
|---|---|---|---|---|
|
Number of Participants With Readmission to Hospital for Treatment of Atrial Fibrillation
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
Adverse Events
Group A
Serious events: 1 serious events
Other events: 29 other events
Deaths: 1 deaths
Group B
Serious events: 3 serious events
Other events: 29 other events
Deaths: 1 deaths
Group C
Serious events: 1 serious events
Other events: 21 other events
Deaths: 1 deaths
Group D
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=76 participants at risk
Beta Blockers, Ascorbic Acid and Amiodarone
beta blockers: metoprolol 25mg by mouth every 6 hours
amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively
ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days
|
Group B
n=74 participants at risk
Beta Blockers and Ascorbic Acid
beta blockers: metoprolol 25mg by mouth every 6 hours
ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days
|
Group C
n=78 participants at risk
Beta Blockers and Amiodarone
beta blockers: metoprolol 25mg by mouth every 6 hours
amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively
|
Group D
n=76 participants at risk
Beta Blockers alone
beta blockers: metoprolol 25mg by mouth every 6 hours
|
|---|---|---|---|---|
|
Nervous system disorders
Cerebral Vascular Accident
|
1.3%
1/76 • Number of events 1
|
4.1%
3/74 • Number of events 3
|
1.3%
1/78 • Number of events 1
|
1.3%
1/76 • Number of events 1
|
Other adverse events
| Measure |
Group A
n=76 participants at risk
Beta Blockers, Ascorbic Acid and Amiodarone
beta blockers: metoprolol 25mg by mouth every 6 hours
amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively
ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days
|
Group B
n=74 participants at risk
Beta Blockers and Ascorbic Acid
beta blockers: metoprolol 25mg by mouth every 6 hours
ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days
|
Group C
n=78 participants at risk
Beta Blockers and Amiodarone
beta blockers: metoprolol 25mg by mouth every 6 hours
amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively
|
Group D
n=76 participants at risk
Beta Blockers alone
beta blockers: metoprolol 25mg by mouth every 6 hours
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
38.2%
29/76 • Number of events 29
|
39.2%
29/74 • Number of events 29
|
26.9%
21/78 • Number of events 21
|
35.5%
27/76 • Number of events 27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place