Trial Outcomes & Findings for Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation (NCT NCT01924065)
NCT ID: NCT01924065
Last Updated: 2024-11-15
Results Overview
Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
112 participants
Primary outcome timeframe
2 years
Results posted on
2024-11-15
Participant Flow
Participant milestones
| Measure |
Transesophageal Echocardiography Group
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Cardioversion: Electrical cardioversion
|
Oral Anticoagulant Group
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Cardioversion: Electrical cardioversion
Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
|
Overall Study
COMPLETED
|
56
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Transesophageal Echocardiography Group
n=56 Participants
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Cardioversion: Electrical cardioversion
|
Oral Anticoagulant Group
n=56 Participants
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Cardioversion: Electrical cardioversion
Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
60 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
60.5 years
STANDARD_DEVIATION 11.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
56 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Turkey
|
56 participants
n=99 Participants
|
56 participants
n=107 Participants
|
112 participants
n=206 Participants
|
|
Hypertension
|
27 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Diabetes mellitus
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Coronary artery disease
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Heart rate
|
104.5 Beats per minute
STANDARD_DEVIATION 23.9 • n=99 Participants
|
98.3 Beats per minute
STANDARD_DEVIATION 23 • n=107 Participants
|
101.5 Beats per minute
STANDARD_DEVIATION 23.6 • n=206 Participants
|
|
Left atrial diameter
|
41 mm
STANDARD_DEVIATION 3.7 • n=99 Participants
|
42.1 mm
STANDARD_DEVIATION 3.4 • n=107 Participants
|
41.6 mm
STANDARD_DEVIATION 3.6 • n=206 Participants
|
|
Ejection fraction
|
61.3 percent
STANDARD_DEVIATION 6.2 • n=99 Participants
|
60 percent
STANDARD_DEVIATION 6 • n=107 Participants
|
60.5 percent
STANDARD_DEVIATION 6.1 • n=206 Participants
|
|
Type of atrial fibrillation
Paroxysmal
|
37 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Type of atrial fibrillation
Persistent
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Duration of atrial fibrillation
|
3.5 day
n=99 Participants
|
4 day
n=107 Participants
|
4 day
n=206 Participants
|
|
Beta blocker
|
19 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Calcium channel blocker
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Amiodarone
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Propafenone
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Acetylsalicylic acid
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Clopidogrel
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Angiotensin converting enzyme inhibitor, Angiotensin receptor blocker
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Spironolactone
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Congestive heart failure, Hypertension, Age 2, Diabetes, Stroke 2, Vascular, Sex Category Score
|
1.44 units on a scale
STANDARD_DEVIATION 1.11 • n=99 Participants
|
1.62 units on a scale
STANDARD_DEVIATION 1.05 • n=107 Participants
|
1.53 units on a scale
STANDARD_DEVIATION 1.08 • n=206 Participants
|
|
Hypertension,Abnormal liver/renal function, Stroke, Bleeding, LabileINR, Elderly, Drug/alcohol Score
|
0.41 units on a scale
STANDARD_DEVIATION 0.59 • n=99 Participants
|
0.39 units on a scale
STANDARD_DEVIATION 0.62 • n=107 Participants
|
0.4 units on a scale
STANDARD_DEVIATION 0.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsClinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion
Outcome measures
| Measure |
Transesophageal Echocardiography Group
n=56 Participants
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Cardioversion: Electrical cardioversion
|
Oral Anticoagulant Group
n=56 Participants
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Cardioversion: Electrical cardioversion
Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
|
|---|---|---|
|
Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli
|
9 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 2 yearsAny Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli
Outcome measures
| Measure |
Transesophageal Echocardiography Group
n=56 Participants
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Cardioversion: Electrical cardioversion
|
Oral Anticoagulant Group
n=56 Participants
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Cardioversion: Electrical cardioversion
Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
|
|---|---|---|
|
Efficacy Clinical End-point
|
7 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Transesophageal Echocardiography Group
n=56 Participants
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Cardioversion: Electrical cardioversion
|
Oral Anticoagulant Group
n=56 Participants
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Cardioversion: Electrical cardioversion
Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
|
|---|---|---|
|
Ischemic Stroke/Transient Ischemic Attack
|
7 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 1 weekDevelopment of acute silent cerebral ischemia detected by MRI
Outcome measures
| Measure |
Transesophageal Echocardiography Group
n=56 Participants
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Cardioversion: Electrical cardioversion
|
Oral Anticoagulant Group
n=56 Participants
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Cardioversion: Electrical cardioversion
Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
|
|---|---|---|
|
Acute Ischemia in MRI
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Transesophageal Echocardiography Group
n=56 Participants
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Cardioversion: Electrical cardioversion
|
Oral Anticoagulant Group
n=56 Participants
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Cardioversion: Electrical cardioversion
Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
|
|---|---|---|
|
Mortality
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Transesophageal Echocardiography Group
n=56 Participants
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Cardioversion: Electrical cardioversion
|
Oral Anticoagulant Group
n=56 Participants
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Cardioversion: Electrical cardioversion
Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
|
|---|---|---|
|
Hemorrhagic Stroke
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Transesophageal Echocardiography Group
n=56 Participants
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Cardioversion: Electrical cardioversion
|
Oral Anticoagulant Group
n=56 Participants
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Cardioversion: Electrical cardioversion
Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
|
|---|---|---|
|
Gastrointestinal Bleeding
|
3 Participants
|
2 Participants
|
Adverse Events
Transesophageal Echocardiography Group
Serious events: 9 serious events
Other events: 0 other events
Deaths: 3 deaths
Oral Anticoagulation Group
Serious events: 10 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Transesophageal Echocardiography Group
n=56 participants at risk
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Cardioversion: Electrical cardioversion
|
Oral Anticoagulation Group
n=56 participants at risk
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Cardioversion: Electrical cardioversion
Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
|
|---|---|---|
|
Nervous system disorders
Ischemic stroke-transient ischemic attack
|
7.1%
4/56 • 2 years
|
12.5%
7/56 • 2 years
|
|
Nervous system disorders
Hemorrhagic stroke
|
3.6%
2/56 • 2 years
|
1.8%
1/56 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
5.4%
3/56 • 2 years
|
3.6%
2/56 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place