ID

40997

Description

Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm; ODM derived from: https://clinicaltrials.gov/show/NCT00911300

Link

https://clinicaltrials.gov/show/NCT00911300

Keywords

Versions (1)
  1. 6/9/20 6/9/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 9, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Fibrillation, Atrial NCT00911300

English

Eligibility Fibrillation, Atrial NCT00911300

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged at least 18 years with atrial fibrillation (af) meeting at least one of the following criteria (a, b, c): a. acute clinical symptoms (like palpitations, chest pain, dyspnea, fatigue, lightheadedness, or syncope) for at least 48 hours and af on baseline ecg b. newly discovered af persisting for >=7 days c. recurrent af persisting for >=7 days
Description

Age | Atrial Fibrillation | Criteria Quantity Fulfill | Symptoms Clinical | Palpitations | Chest Pain | Dyspnea | Fatigue | Lightheadedness | Syncope | Atrial Fibrillation by ECG Finding | Atrial Fibrillation Newly Diagnosed Persistent | Recurrent atrial fibrillation Persistent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0004238
UMLS CUI [3,1]
C0243161
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1550543
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0205210
UMLS CUI [5]
C0030252
UMLS CUI [6]
C0008031
UMLS CUI [7]
C0013404
UMLS CUI [8]
C0015672
UMLS CUI [9]
C0220870
UMLS CUI [10]
C0039070
UMLS CUI [11]
C0344434
UMLS CUI [12,1]
C0004238
UMLS CUI [12,2]
C1518321
UMLS CUI [12,3]
C0205322
UMLS CUI [13,1]
C0741282
UMLS CUI [13,2]
C0205322
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no documented sinus rhythm on ecg for more than 1 year
Description

Sinus rhythm Absent Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0232201
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1623258
acute neurological deficits (tia, stroke, intracranial bleeding), or known disease which may cause neurological deficits (e.g., multiple sclerosis, seizure disorder)
Description

Neurologic Deficits | Transient Ischemic Attack | Cerebrovascular accident | Intracranial Hemorrhages | Disease Causing Neurologic Deficits | Multiple Sclerosis | Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0521654
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0151699
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0678227
UMLS CUI [5,3]
C0521654
UMLS CUI [6]
C0026769
UMLS CUI [7]
C0014544
treatment with antithrombotic agents, including low-dose anticoagulation, for more than 48 hours prior to randomisation
Description

Fibrinolytic Agents | Anticoagulation Therapy Low dose

Data type

boolean

Alias
UMLS CUI [1]
C0016018
UMLS CUI [2,1]
C0003281
UMLS CUI [2,2]
C0445550
treatment with oral nsaids or asa at doses greater than 325 mg per day for more than 72 hours prior to randomisation
Description

NSAIDs Oral Dose U/day | Aspirin Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0456683
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
anticoagulant therapy required or likely to be required during the study period
Description

Anticoagulant therapy Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C1514873
treatment with asa at a dose greater than 325 mg per day or oral nsaids (at any dose) required or likely to be required during the study period
Description

Aspirin Dose U/day | Non-Steroidal Anti-Inflammatory Agents Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1527415
treatment with two or more antiplatelet agents (e.g. clopidogrel and asa) at any dose at the same time (i.e., within 24 hours)
Description

Antiplatelet Agents Quantity | clopidogrel | Aspirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0085826
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0070166
UMLS CUI [3]
C0004057
known hypersensitivity to ufh, vka, or fondaparinux or one of these drugs' excipients
Description

Heparin allergy | Hypersensitivity Vitamin K Antagonist | Hypersensitivity Fondaparinux | Hypersensitivity Excipient Unfractionated heparin | Hypersensitivity Excipient Vitamin K Antagonist | Hypersensitivity Excipient Fondaparinux

Data type

boolean

Alias
UMLS CUI [1]
C0571776
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2267235
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1098510
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0015237
UMLS CUI [4,3]
C0019134
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0015237
UMLS CUI [5,3]
C2267235
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0015237
UMLS CUI [6,3]
C1098510
active, clinically significant bleeding or clinically significant bleeding within the past month
Description

BLEEDING ACTIVE Clinical Significance | Hemorrhage Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0741554
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C2826293
major surgery within the previous three months
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
uncontrolled arterial hypertension (persistent systolic blood pressure over 180 mm hg or diastolic blood pressure over 110 mm hg)
Description

Uncontrolled hypertension | Systolic Pressure Persistent | Diastolic blood pressure Persistent

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0205322
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0205322
bacterial endocarditis
Description

Bacterial Endocarditis

Data type

boolean

Alias
UMLS CUI [1]
C0014121
calculated creatinine clearance < 30 ml/min
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
body weight < 50 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
planned surgery or intervention within the next 65 days
Description

Operative Surgical Procedure Planned | Intervention Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1301732
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Similar models

Eligibility Fibrillation, Atrial NCT00911300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Atrial Fibrillation | Criteria Quantity Fulfill | Symptoms Clinical | Palpitations | Chest Pain | Dyspnea | Fatigue | Lightheadedness | Syncope | Atrial Fibrillation by ECG Finding | Atrial Fibrillation Newly Diagnosed Persistent | Recurrent atrial fibrillation Persistent
Item
male or female patients aged at least 18 years with atrial fibrillation (af) meeting at least one of the following criteria (a, b, c): a. acute clinical symptoms (like palpitations, chest pain, dyspnea, fatigue, lightheadedness, or syncope) for at least 48 hours and af on baseline ecg b. newly discovered af persisting for >=7 days c. recurrent af persisting for >=7 days
boolean
C0001779 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
C0243161 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1550543 (UMLS CUI [3,3])
C1457887 (UMLS CUI [4,1])
C0205210 (UMLS CUI [4,2])
C0030252 (UMLS CUI [5])
C0008031 (UMLS CUI [6])
C0013404 (UMLS CUI [7])
C0015672 (UMLS CUI [8])
C0220870 (UMLS CUI [9])
C0039070 (UMLS CUI [10])
C0344434 (UMLS CUI [11])
C0004238 (UMLS CUI [12,1])
C1518321 (UMLS CUI [12,2])
C0205322 (UMLS CUI [12,3])
C0741282 (UMLS CUI [13,1])
C0205322 (UMLS CUI [13,2])
Item Group
C0680251 (UMLS CUI)
Sinus rhythm Absent Electrocardiography
Item
no documented sinus rhythm on ecg for more than 1 year
boolean
C0232201 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,3])
Neurologic Deficits | Transient Ischemic Attack | Cerebrovascular accident | Intracranial Hemorrhages | Disease Causing Neurologic Deficits | Multiple Sclerosis | Epilepsy
Item
acute neurological deficits (tia, stroke, intracranial bleeding), or known disease which may cause neurological deficits (e.g., multiple sclerosis, seizure disorder)
boolean
C0521654 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0151699 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0678227 (UMLS CUI [5,2])
C0521654 (UMLS CUI [5,3])
C0026769 (UMLS CUI [6])
C0014544 (UMLS CUI [7])
Fibrinolytic Agents | Anticoagulation Therapy Low dose
Item
treatment with antithrombotic agents, including low-dose anticoagulation, for more than 48 hours prior to randomisation
boolean
C0016018 (UMLS CUI [1])
C0003281 (UMLS CUI [2,1])
C0445550 (UMLS CUI [2,2])
NSAIDs Oral Dose U/day | Aspirin Dose U/day
Item
treatment with oral nsaids or asa at doses greater than 325 mg per day for more than 72 hours prior to randomisation
boolean
C0003211 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0004057 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Anticoagulant therapy Required
Item
anticoagulant therapy required or likely to be required during the study period
boolean
C0150457 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Aspirin Dose U/day | Non-Steroidal Anti-Inflammatory Agents Oral
Item
treatment with asa at a dose greater than 325 mg per day or oral nsaids (at any dose) required or likely to be required during the study period
boolean
C0004057 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
Antiplatelet Agents Quantity | clopidogrel | Aspirin
Item
treatment with two or more antiplatelet agents (e.g. clopidogrel and asa) at any dose at the same time (i.e., within 24 hours)
boolean
C0085826 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0070166 (UMLS CUI [2])
C0004057 (UMLS CUI [3])
Heparin allergy | Hypersensitivity Vitamin K Antagonist | Hypersensitivity Fondaparinux | Hypersensitivity Excipient Unfractionated heparin | Hypersensitivity Excipient Vitamin K Antagonist | Hypersensitivity Excipient Fondaparinux
Item
known hypersensitivity to ufh, vka, or fondaparinux or one of these drugs' excipients
boolean
C0571776 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C2267235 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1098510 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0015237 (UMLS CUI [4,2])
C0019134 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0015237 (UMLS CUI [5,2])
C2267235 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0015237 (UMLS CUI [6,2])
C1098510 (UMLS CUI [6,3])
BLEEDING ACTIVE Clinical Significance | Hemorrhage Clinical Significance
Item
active, clinically significant bleeding or clinically significant bleeding within the past month
boolean
C0741554 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Major surgery
Item
major surgery within the previous three months
boolean
C0679637 (UMLS CUI [1])
Uncontrolled hypertension | Systolic Pressure Persistent | Diastolic blood pressure Persistent
Item
uncontrolled arterial hypertension (persistent systolic blood pressure over 180 mm hg or diastolic blood pressure over 110 mm hg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
Bacterial Endocarditis
Item
bacterial endocarditis
boolean
C0014121 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance < 30 ml/min
boolean
C2711451 (UMLS CUI [1])
Body Weight
Item
body weight < 50 kg
boolean
C0005910 (UMLS CUI [1])
Operative Surgical Procedure Planned | Intervention Planned
Item
planned surgery or intervention within the next 65 days
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
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