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

  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

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Description

Inclusion criteria

History of atrial fibrillation
Description

History of atrial fibrillation

Data type

boolean

Cardioversion
Description

Cardioversion

Data type

boolean

Anticoagulation
Description

Anticoagulation

Data type

boolean

Exclusion criteria
Description

Exclusion criteria

Previous cardioversions
Description

Previous cardioversions

Data type

boolean

Antiarrhythmic drugs
Description

Antiarrhythmic drugs

Data type

boolean

Qualifying arrhythmia
Description

Qualifying arrhythmia

Data type

boolean

Medizinische Konzepte
Description

Medizinische Konzepte

Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
AF
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
ECG
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
Pharmaceutical Preparations
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

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
History of atrial fibrillation
Item
boolean
Cardioversion
Item
boolean
Anticoagulation
Item
boolean
Previous cardioversions
Item
boolean
Antiarrhythmic drugs
Item
boolean
Qualifying arrhythmia
Item
boolean
Item Group
Medizinische Konzepte
Diagnosis
Item
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
AF
Item
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
string
C1623258 (UMLS CUI)
46825001 (SNOMED CT 2010_0731)
10014084 (MedDRA 13.1)
Therapeutic procedure
Item
string
C0087111 (UMLS CUI)
Cardioversion
Item
string
C0013778 (UMLS CUI)
250980009 (SNOMED CT 2010_0731)
10007661 (MedDRA 13.1)
LP97905-1 (LOINC Version 232)
Use of anticoagulation
Item
string
C0449867 (UMLS CUI)
260678004 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
string
C0013227 (UMLS CUI)
Antiarrhythmic drug
Item
string
C0003195 (UMLS CUI)
67507000 (SNOMED CT 2010_0731)
Cardiac Arrhythmia
Item
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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