ID

37561

Beschrijving

Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion; ODM derived from: https://clinicaltrials.gov/show/NCT01674647

Link

https://clinicaltrials.gov/show/NCT01674647

Trefwoorden

Versies (1)
  1. 07-08-19 07-08-19 -
Houder van rechten

See clinicaltrials.gov

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7 augustus 2019

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01674647

Engels

Eligibility Atrial Fibrillation NCT01674647

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women aged >= 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of unknown duration
Beschrijving

Atrial Fibrillation Disease length | Exception Heart Valve Involvement | Hemodynamics Stable | Atrial Fibrillation Duration Unknown

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018826
UMLS CUI [2,3]
C1314939
UMLS CUI [3,1]
C0019010
UMLS CUI [3,2]
C0205360
UMLS CUI [4,1]
C0004238
UMLS CUI [4,2]
C0449238
UMLS CUI [4,3]
C0439673
scheduled for cardioversion (electrical or pharmacological) of nonvalvular atrial fibrillation
Beschrijving

Electric Countershock Scheduled Atrial Fibrillation | Exception Heart Valve Involvement | Pharmacological cardioversion Scheduled Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013778
UMLS CUI [1,2]
C0205539
UMLS CUI [1,3]
C0004238
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018826
UMLS CUI [2,3]
C1314939
UMLS CUI [3,1]
C1963873
UMLS CUI [3,2]
C0205539
UMLS CUI [3,3]
C0004238
women of childbearing potential and men must agree to use adequate contraception when sexually active
Beschrijving

Childbearing Potential Sexually active Contraceptive methods | Gender Sexually active Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe, disabling stroke (modified rankin score of 4- 5, inclusive) within 3 months or any stroke within 14 days prior to randomization
Beschrijving

Cerebrovascular accident Severely disabling Modified Rankin Scale | Cerebrovascular accident Any

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C4035398
UMLS CUI [1,3]
C2984908
UMLS CUI [2,1]
C0038454
UMLS CUI [2,2]
C1552551
transient ischemic attack within 3 days prior to randomization
Beschrijving

Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0007787
acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
Beschrijving

Thromboembolism | Venous Thrombosis | Arterial thrombosis

Datatype

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2]
C0042487
UMLS CUI [3]
C0151942
acute myocardial infarction (mi) within the last 14 days prior to randomization
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
cardiac-related criteria: known presence of cardiac thombus or myxoma or valvular atrial fibrillation
Beschrijving

Criteria Heart Related | Thrombus of cardiac chamber | Myxoma | Heart Valve Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0439849
UMLS CUI [2]
C0876998
UMLS CUI [3]
C0027149
UMLS CUI [4,1]
C0018826
UMLS CUI [4,2]
C0004238
active bleeding or high risk for bleeding contraindicating anticoagulant therapy
Beschrijving

Hemorrhage | High risk of bleeding Contraindicated Anticoagulant therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2,1]
C4039184
UMLS CUI [2,2]
C1444657
UMLS CUI [2,3]
C0150457
concomitant medications: indication for anticoagulant therapy other than atrial fibrillation, chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy, strong inhibitors of both cytochrome p450 (cyp) 3a4 and p-glycoprotein (p-gp) if used systemically
Beschrijving

Pharmaceutical Preparations concomitant | Indication Anticoagulant therapy | Exception Atrial Fibrillation | Aspirin therapy chronic U/day | Antiplatelet therapy Dual | CYP3A4 Inhibitors Strong Systemic | P-Glycoprotein Inhibitors Strong Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521115
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0150457
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0004238
UMLS CUI [4,1]
C4303556
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C0456683
UMLS CUI [5,1]
C1096021
UMLS CUI [5,2]
C0205173
UMLS CUI [6,1]
C3850053
UMLS CUI [6,2]
C0442821
UMLS CUI [6,3]
C0205373
UMLS CUI [7,1]
C3500483
UMLS CUI [7,2]
C0442821
UMLS CUI [7,3]
C0205373
concomitant conditions: childbearing potential without proper contraceptive measures, pregnancy, or breast feeding; hypersensitivity to investigational treatment or comparator treatment; calculated creatinine clearance (crcl) < 30 ml/minute; hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk; any severe condition that would limit life expectancy to less than 6 months; planned invasive procedure with potential for uncontrolled bleeding; inability to take oral medication; ongoing drug addiction or alcohol abuse
Beschrijving

Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding | Hypersensitivity Investigational Therapy | Hypersensitivity Comparator Treatment | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver disease Associated with Blood Coagulation Disorder | Bleeding risk | Condition Severe Limiting Life Expectancy | Invasive procedure Planned | At risk Bleeding uncontrolled | Lacking Able to swallow Oral medication | Drug Dependence | Alcohol abuse

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0949266
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1707454
UMLS CUI [5,3]
C0087111
UMLS CUI [6]
C2711451
UMLS CUI [7,1]
C0023895
UMLS CUI [7,2]
C0332281
UMLS CUI [7,3]
C0005779
UMLS CUI [8]
C3251812
UMLS CUI [9,1]
C0348080
UMLS CUI [9,2]
C0205082
UMLS CUI [9,3]
C0439801
UMLS CUI [9,4]
C0023671
UMLS CUI [10,1]
C4048276
UMLS CUI [10,2]
C1301732
UMLS CUI [11,1]
C1444641
UMLS CUI [11,2]
C3842135
UMLS CUI [12,1]
C0332268
UMLS CUI [12,2]
C2712086
UMLS CUI [12,3]
C0175795
UMLS CUI [13]
C1510472
UMLS CUI [14]
C0085762
any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
Beschrijving

Medical contraindication Consistent with Drug Labeling | Comparator Treatment | Investigational Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0013191
UMLS CUI [2,1]
C1707454
UMLS CUI [2,2]
C0087111
UMLS CUI [3]
C0949266
participation in a study with an investigational drug or medical device within 30 days prior to randomization
Beschrijving

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Similar models

Eligibility Atrial Fibrillation NCT01674647

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women aged >= 18 years
boolean
C0001779 (UMLS CUI [1])
Atrial Fibrillation Disease length | Exception Heart Valve Involvement | Hemodynamics Stable | Atrial Fibrillation Duration Unknown
Item
hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of unknown duration
boolean
C0004238 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0018826 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0019010 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0004238 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
C0439673 (UMLS CUI [4,3])
Electric Countershock Scheduled Atrial Fibrillation | Exception Heart Valve Involvement | Pharmacological cardioversion Scheduled Atrial Fibrillation
Item
scheduled for cardioversion (electrical or pharmacological) of nonvalvular atrial fibrillation
boolean
C0013778 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018826 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C1963873 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C0004238 (UMLS CUI [3,3])
Childbearing Potential Sexually active Contraceptive methods | Gender Sexually active Contraceptive methods
Item
women of childbearing potential and men must agree to use adequate contraception when sexually active
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident Severely disabling Modified Rankin Scale | Cerebrovascular accident Any
Item
severe, disabling stroke (modified rankin score of 4- 5, inclusive) within 3 months or any stroke within 14 days prior to randomization
boolean
C0038454 (UMLS CUI [1,1])
C4035398 (UMLS CUI [1,2])
C2984908 (UMLS CUI [1,3])
C0038454 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Transient Ischemic Attack
Item
transient ischemic attack within 3 days prior to randomization
boolean
C0007787 (UMLS CUI [1])
Thromboembolism | Venous Thrombosis | Arterial thrombosis
Item
acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
boolean
C0040038 (UMLS CUI [1])
C0042487 (UMLS CUI [2])
C0151942 (UMLS CUI [3])
Myocardial Infarction
Item
acute myocardial infarction (mi) within the last 14 days prior to randomization
boolean
C0027051 (UMLS CUI [1])
Criteria Heart Related | Thrombus of cardiac chamber | Myxoma | Heart Valve Atrial Fibrillation
Item
cardiac-related criteria: known presence of cardiac thombus or myxoma or valvular atrial fibrillation
boolean
C0243161 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0876998 (UMLS CUI [2])
C0027149 (UMLS CUI [3])
C0018826 (UMLS CUI [4,1])
C0004238 (UMLS CUI [4,2])
Hemorrhage | High risk of bleeding Contraindicated Anticoagulant therapy
Item
active bleeding or high risk for bleeding contraindicating anticoagulant therapy
boolean
C0019080 (UMLS CUI [1])
C4039184 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
C0150457 (UMLS CUI [2,3])
Pharmaceutical Preparations concomitant | Indication Anticoagulant therapy | Exception Atrial Fibrillation | Aspirin therapy chronic U/day | Antiplatelet therapy Dual | CYP3A4 Inhibitors Strong Systemic | P-Glycoprotein Inhibitors Strong Systemic
Item
concomitant medications: indication for anticoagulant therapy other than atrial fibrillation, chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy, strong inhibitors of both cytochrome p450 (cyp) 3a4 and p-glycoprotein (p-gp) if used systemically
boolean
C0013227 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0150457 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0004238 (UMLS CUI [3,2])
C4303556 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
C1096021 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C3850053 (UMLS CUI [6,1])
C0442821 (UMLS CUI [6,2])
C0205373 (UMLS CUI [6,3])
C3500483 (UMLS CUI [7,1])
C0442821 (UMLS CUI [7,2])
C0205373 (UMLS CUI [7,3])
Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding | Hypersensitivity Investigational Therapy | Hypersensitivity Comparator Treatment | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver disease Associated with Blood Coagulation Disorder | Bleeding risk | Condition Severe Limiting Life Expectancy | Invasive procedure Planned | At risk Bleeding uncontrolled | Lacking Able to swallow Oral medication | Drug Dependence | Alcohol abuse
Item
concomitant conditions: childbearing potential without proper contraceptive measures, pregnancy, or breast feeding; hypersensitivity to investigational treatment or comparator treatment; calculated creatinine clearance (crcl) < 30 ml/minute; hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk; any severe condition that would limit life expectancy to less than 6 months; planned invasive procedure with potential for uncontrolled bleeding; inability to take oral medication; ongoing drug addiction or alcohol abuse
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0949266 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C1707454 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
C2711451 (UMLS CUI [6])
C0023895 (UMLS CUI [7,1])
C0332281 (UMLS CUI [7,2])
C0005779 (UMLS CUI [7,3])
C3251812 (UMLS CUI [8])
C0348080 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0439801 (UMLS CUI [9,3])
C0023671 (UMLS CUI [9,4])
C4048276 (UMLS CUI [10,1])
C1301732 (UMLS CUI [10,2])
C1444641 (UMLS CUI [11,1])
C3842135 (UMLS CUI [11,2])
C0332268 (UMLS CUI [12,1])
C2712086 (UMLS CUI [12,2])
C0175795 (UMLS CUI [12,3])
C1510472 (UMLS CUI [13])
C0085762 (UMLS CUI [14])
Medical contraindication Consistent with Drug Labeling | Comparator Treatment | Investigational Therapy
Item
any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
boolean
C1301624 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0013191 (UMLS CUI [1,3])
C1707454 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0949266 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in a study with an investigational drug or medical device within 30 days prior to randomization
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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