ID

37465

Description

Phase 2 Study of Oral K201 for Prevention of AF Recurrence; ODM derived from: https://clinicaltrials.gov/show/NCT01067833

Link

https://clinicaltrials.gov/show/NCT01067833

Keywords

Versions (1)
  1. 7/30/19 7/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 30, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01067833

English

Eligibility Atrial Fibrillation NCT01067833

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic af (sustained >3 days and <6 months) and clinically indicated for cardioversion;
Description

ATRIAL FIBRILLATION SYMPTOMATIC Duration | Indication Electric Countershock

Data type

boolean

Alias
UMLS CUI [1,1]
C0741283
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013778
adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by acc/aha/esc guidelines or with local clinical practice;
Description

Anticoagulant therapy Electric Countershock

Data type

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C0013778
hemodynamically stable (90 mmhg < systolic blood pressure < 190 mmhg)at screening and on day 1;
Description

Stable status Hemodynamic | Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0019010
UMLS CUI [2]
C0871470
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known prolonged qt syndrome or qtc interval of >0.500 sec at screening; familial long qt syndrome; previous torsade de pointes; ventricular fibrillation; or sustained ventricular tachycardia (vt);
Description

Long QT Syndrome | QTc interval | Family history of long QT syndrome | Torsades de Pointes | Ventricular Fibrillation | Sustained ventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2]
C0489625
UMLS CUI [3]
C3839836
UMLS CUI [4]
C0040479
UMLS CUI [5]
C0042510
UMLS CUI [6]
C0750197
qrs >0.130 sec;
Description

QRS duration

Data type

boolean

Alias
UMLS CUI [1]
C0429025
previous episodes of second- or third-degree atrioventricular block;
Description

Episode of Second degree atrioventricular block | Episode of Complete atrioventricular block

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0264906
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0151517
unsuccessful dc cardioversion attempt within 3 months; prior ablation for af;
Description

Direct current cardioversion Attempt Unsuccessful | Catheter ablation for atrial fibrillation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0542380
UMLS CUI [1,2]
C1516084
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C2702800
UMLS CUI [2,2]
C0205156
persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including crt, aicd);
Description

Bradycardia Persistent | Ventricular Heart Rate | Sick Sinus Syndrome | Artificial cardiac pacemaker | Cardiac Resynchronization Therapy Device | Automatic Implantable Cardioverter-Defibrillators

Data type

boolean

Alias
UMLS CUI [1,1]
C0428977
UMLS CUI [1,2]
C0205322
UMLS CUI [2]
C1883530
UMLS CUI [3]
C0037052
UMLS CUI [4]
C0030163
UMLS CUI [5]
C2936377
UMLS CUI [6]
C0972395
myocardial infarction (mi), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
Description

Myocardial Infarction | Cardiac Surgery | Angioplasty | Angina, Unstable | Acute Coronary Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0018821
UMLS CUI [3]
C0162577
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0948089
nyha class iii or class iv heart failure (hf) at screening or admission, or hospitalized for hf in previous 6 months;
Description

Heart failure New York Heart Association Classification | Hospitalization Due to Heart Failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C3898876
known concurrent temporary secondary causes of af;
Description

Cause Temporary Secondary Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205374
UMLS CUI [1,3]
C0175668
UMLS CUI [1,4]
C0004238
received a class i or class iii antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;
Description

Anti-Arrhythmia Agents Class | Sotalol | Amiodarone | dronedarone

Data type

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0456387
UMLS CUI [2]
C0037707
UMLS CUI [3]
C0002598
UMLS CUI [4]
C0766326
received treatment with other drugs known to prolong the qt interval within 5 half-lives.
Description

Pharmaceutical Preparations Causing Prolonged QT interval

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
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Similar models

Eligibility Atrial Fibrillation NCT01067833

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ATRIAL FIBRILLATION SYMPTOMATIC Duration | Indication Electric Countershock
Item
symptomatic af (sustained >3 days and <6 months) and clinically indicated for cardioversion;
boolean
C0741283 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0013778 (UMLS CUI [2,2])
Anticoagulant therapy Electric Countershock
Item
adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by acc/aha/esc guidelines or with local clinical practice;
boolean
C0150457 (UMLS CUI [1,1])
C0013778 (UMLS CUI [1,2])
Stable status Hemodynamic | Systolic Pressure
Item
hemodynamically stable (90 mmhg < systolic blood pressure < 190 mmhg)at screening and on day 1;
boolean
C0205360 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Long QT Syndrome | QTc interval | Family history of long QT syndrome | Torsades de Pointes | Ventricular Fibrillation | Sustained ventricular tachycardia
Item
known prolonged qt syndrome or qtc interval of >0.500 sec at screening; familial long qt syndrome; previous torsade de pointes; ventricular fibrillation; or sustained ventricular tachycardia (vt);
boolean
C0023976 (UMLS CUI [1])
C0489625 (UMLS CUI [2])
C3839836 (UMLS CUI [3])
C0040479 (UMLS CUI [4])
C0042510 (UMLS CUI [5])
C0750197 (UMLS CUI [6])
QRS duration
Item
qrs >0.130 sec;
boolean
C0429025 (UMLS CUI [1])
Episode of Second degree atrioventricular block | Episode of Complete atrioventricular block
Item
previous episodes of second- or third-degree atrioventricular block;
boolean
C0332189 (UMLS CUI [1,1])
C0264906 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C0151517 (UMLS CUI [2,2])
Direct current cardioversion Attempt Unsuccessful | Catheter ablation for atrial fibrillation Previous
Item
unsuccessful dc cardioversion attempt within 3 months; prior ablation for af;
boolean
C0542380 (UMLS CUI [1,1])
C1516084 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C2702800 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Bradycardia Persistent | Ventricular Heart Rate | Sick Sinus Syndrome | Artificial cardiac pacemaker | Cardiac Resynchronization Therapy Device | Automatic Implantable Cardioverter-Defibrillators
Item
persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including crt, aicd);
boolean
C0428977 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C1883530 (UMLS CUI [2])
C0037052 (UMLS CUI [3])
C0030163 (UMLS CUI [4])
C2936377 (UMLS CUI [5])
C0972395 (UMLS CUI [6])
Myocardial Infarction | Cardiac Surgery | Angioplasty | Angina, Unstable | Acute Coronary Syndrome
Item
myocardial infarction (mi), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
boolean
C0027051 (UMLS CUI [1])
C0018821 (UMLS CUI [2])
C0162577 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0948089 (UMLS CUI [5])
Heart failure New York Heart Association Classification | Hospitalization Due to Heart Failure
Item
nyha class iii or class iv heart failure (hf) at screening or admission, or hospitalized for hf in previous 6 months;
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C3898876 (UMLS CUI [2])
Cause Temporary Secondary Atrial Fibrillation
Item
known concurrent temporary secondary causes of af;
boolean
C0015127 (UMLS CUI [1,1])
C0205374 (UMLS CUI [1,2])
C0175668 (UMLS CUI [1,3])
C0004238 (UMLS CUI [1,4])
Anti-Arrhythmia Agents Class | Sotalol | Amiodarone | dronedarone
Item
received a class i or class iii antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;
boolean
C0003195 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0037707 (UMLS CUI [2])
C0002598 (UMLS CUI [3])
C0766326 (UMLS CUI [4])
Pharmaceutical Preparations Causing Prolonged QT interval
Item
received treatment with other drugs known to prolong the qt interval within 5 half-lives.
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
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