ID

49

Description

Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation. Inclusion criteria: - Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening - Require the procedure of cardioversion (electric shock to correct abnormal rhythm) - In the investigator's opinion, is likely to maintain sinus rhythm after cardioversion. - Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines. Exclusion criteria: - Previously unsuccessful electrical cardioversions - Failed to respond to any Class III antiarrhythmic drugs - Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization

Keywords

Versions (2)
  1. 11/11/11 11/11/11 -
  2. 3/21/14 3/21/14 - Martin Dugas
Uploaded on

November 11, 2011

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility Criteria NCT00035451 AF

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Description

Inclusion criteria

Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening
Description

History of atrial fibrillation

Data type

boolean

procedure of cardioversion (electric shock to correct abnormal rhythm)
Description

Cardioversion

Data type

boolean

Patient anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines
Description

Anticoagulation

Data type

boolean

Exclusion criteria
Description

Exclusion criteria

Previously unsuccessful electrical cardioversions
Description

Previous cardioversions

Data type

boolean

Failed to respond to any Class III antiarrhythmic drugs
Description

Antiarrhythmic drugs

Data type

boolean

Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization
Description

Qualifying arrhythmia

Data type

boolean

Medical Concepts
Description

Medical Concepts

Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Atrial fibrillation
Description

AF

Data type

string

Alias
UMLS CUI
C0004238
SNOMED CT 2010_0731
49436004
MedDRA 13.1
10003658
ICD-9-CM Version 2011
427.31
ICD-10-CM Version 2010
I48.0
CTCAE Version 4.03
E10081
Electrocardiogram
Description

ECG

Data type

string

Alias
UMLS CUI
C1623258
SNOMED CT 2010_0731
46825001
MedDRA 13.1
10014084
Therapeutic procedure
Description

Therapeutic procedure

Data type

string

Alias
UMLS CUI
C0087111
Cardioversion
Description

Cardioversion

Data type

string

Alias
UMLS CUI
C0013778
SNOMED CT 2010_0731
250980009
MedDRA 13.1
10007661
LOINC Version 232
LP97905-1
Use of anticoagulation
Description

Use of anticoagulation

Data type

string

Alias
UMLS CUI
C0449867
SNOMED CT 2010_0731
260678004
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Antiarrhythmic drug
Description

Antiarrhythmic drug

Data type

string

Alias
UMLS CUI
C0003195
SNOMED CT 2010_0731
67507000
Cardiac Arrhythmia
Description

Cardiac Arrhythmia

Data type

string

Alias
UMLS CUI
C0003811
SNOMED CT 2010_0731
44808001
MedDRA 13.1
10003119
ICD-10-CM Version 2010
I49.9
ICD-9-CM Version 2011
427.9
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
History of atrial fibrillation
Item
Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening
boolean
Cardioversion
Item
procedure of cardioversion (electric shock to correct abnormal rhythm)
boolean
Anticoagulation
Item
Patient anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines
boolean
Item Group
Exclusion criteria
Previous cardioversions
Item
Previously unsuccessful electrical cardioversions
boolean
Antiarrhythmic drugs
Item
Failed to respond to any Class III antiarrhythmic drugs
boolean
Qualifying arrhythmia
Item
Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization
boolean
Item Group
Medical Concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
AF
Item
Atrial fibrillation
string
C0004238 (UMLS CUI)
49436004 (SNOMED CT 2010_0731)
10003658 (MedDRA 13.1)
427.31 (ICD-9-CM Version 2011)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE Version 4.03)
ECG
Item
Electrocardiogram
string
C1623258 (UMLS CUI)
46825001 (SNOMED CT 2010_0731)
10014084 (MedDRA 13.1)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
Cardioversion
Item
Cardioversion
string
C0013778 (UMLS CUI)
250980009 (SNOMED CT 2010_0731)
10007661 (MedDRA 13.1)
LP97905-1 (LOINC Version 232)
Use of anticoagulation
Item
Use of anticoagulation
string
C0449867 (UMLS CUI)
260678004 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Antiarrhythmic drug
Item
Antiarrhythmic drug
string
C0003195 (UMLS CUI)
67507000 (SNOMED CT 2010_0731)
Cardiac Arrhythmia
Item
Cardiac Arrhythmia
string
C0003811 (UMLS CUI)
44808001 (SNOMED CT 2010_0731)
10003119 (MedDRA 13.1)
I49.9 (ICD-10-CM Version 2010)
427.9 (ICD-9-CM Version 2011)
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