ID

37527

Descrição

A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055); ODM derived from: https://clinicaltrials.gov/show/NCT01627106

Link

https://clinicaltrials.gov/show/NCT01627106

Palavras-chave

Versões (1)
  1. 05/08/2019 05/08/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

5 de agosto de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01627106

Inglês

Eligibility Atrial Fibrillation NCT01627106

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic af (duration of current episode is ≤7 days), which is hemodynamically stable, and participant has no other condition at the time of screening that may result in acute hospitalization
Descrição

ATRIAL FIBRILLATION SYMPTOMATIC Episode Duration | Hemodynamics Stable | Absence Comorbidity Resulting in Hospitalization

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0741283
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0019010
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0009488
UMLS CUI [3,3]
C0332294
UMLS CUI [3,4]
C0019993
if female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up.
Descrição

Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
weigh at least 45 kg
Descrição

Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
receiving adequate anticoagulant therapy
Descrição

Anticoagulant therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0150457
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine
Descrição

Hypersensitivity Vernakalant | Amiodarone allergy | Hypersensitivity Citric Acid | Hypersensitivity Sodium Chloride | Hypersensitivity Sodium Hydroxide | Iodine allergy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2001572
UMLS CUI [2]
C0571891
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0055819
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0037494
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0037517
UMLS CUI [6]
C0571818
severe aortic stenosis
Descrição

Aortic stenosis, severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3806272
systolic blood pressure <100 mmhg
Descrição

Systolic Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0871470
new york heart association (nyha) class iii or iv heart failure
Descrição

Heart failure New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker
Descrição

Bradycardia, severe | Sinus Node Dysfunction | Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4313412
UMLS CUI [2]
C0428908
UMLS CUI [3]
C0264906
UMLS CUI [4]
C0151517
UMLS CUI [5,1]
C0030163
UMLS CUI [5,2]
C0332197
use of iv rhythm control anti-arrhythmics (class i and iii) within 4 hours of study drug administration
Descrição

Rhythm Control Intravenous | Anti-Arrhythmia Agents Class

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0871269
UMLS CUI [1,2]
C2587213
UMLS CUI [1,3]
C0348016
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C0456387
acute coronary syndrome (including myocardial infarction) within previous 30 days
Descrição

Acute Coronary Syndrome | Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027051
history of thyroid dysfunction
Descrição

Thyroid dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0348024
severe acute respiratory failure or cardiovascular collapse
Descrição

Respiratory Failure Severe | Cardiovascular collapse

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1145670
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0036974
participating in another drug study or has received an investigational drug within 30 days prior to enrollment
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up
Descrição

Pregnancy | Breast Feeding | Pregnancy Expected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1517001
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Eligibility Atrial Fibrillation NCT01627106

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
ATRIAL FIBRILLATION SYMPTOMATIC Episode Duration | Hemodynamics Stable | Absence Comorbidity Resulting in Hospitalization
Item
symptomatic af (duration of current episode is ≤7 days), which is hemodynamically stable, and participant has no other condition at the time of screening that may result in acute hospitalization
boolean
C0741283 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0019010 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
C0332294 (UMLS CUI [3,3])
C0019993 (UMLS CUI [3,4])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods
Item
if female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up.
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Body Weight
Item
weigh at least 45 kg
boolean
C0005910 (UMLS CUI [1])
Anticoagulant therapy
Item
receiving adequate anticoagulant therapy
boolean
C0150457 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Vernakalant | Amiodarone allergy | Hypersensitivity Citric Acid | Hypersensitivity Sodium Chloride | Hypersensitivity Sodium Hydroxide | Iodine allergy
Item
hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine
boolean
C0020517 (UMLS CUI [1,1])
C2001572 (UMLS CUI [1,2])
C0571891 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0055819 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0037494 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0037517 (UMLS CUI [5,2])
C0571818 (UMLS CUI [6])
Aortic stenosis, severe
Item
severe aortic stenosis
boolean
C3806272 (UMLS CUI [1])
Systolic Pressure
Item
systolic blood pressure <100 mmhg
boolean
C0871470 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
new york heart association (nyha) class iii or iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Bradycardia, severe | Sinus Node Dysfunction | Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent
Item
severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker
boolean
C4313412 (UMLS CUI [1])
C0428908 (UMLS CUI [2])
C0264906 (UMLS CUI [3])
C0151517 (UMLS CUI [4])
C0030163 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Rhythm Control Intravenous | Anti-Arrhythmia Agents Class
Item
use of iv rhythm control anti-arrhythmics (class i and iii) within 4 hours of study drug administration
boolean
C0871269 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
C0348016 (UMLS CUI [1,3])
C0003195 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
Acute Coronary Syndrome | Myocardial Infarction
Item
acute coronary syndrome (including myocardial infarction) within previous 30 days
boolean
C0948089 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Thyroid dysfunction
Item
history of thyroid dysfunction
boolean
C0348024 (UMLS CUI [1])
Respiratory Failure Severe | Cardiovascular collapse
Item
severe acute respiratory failure or cardiovascular collapse
boolean
C1145670 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0036974 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participating in another drug study or has received an investigational drug within 30 days prior to enrollment
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy Expected
Item
pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
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