ID

37575

Description

Exploring the Efficacy of Once Daily Oral Rivaroxaban for Treatment of Thrombus in Left Atrial/Left Atrial Appendage in Subjects With Nonvalvular Atrial Fibrillation or Atrial Flutter; ODM derived from: https://clinicaltrials.gov/show/NCT01839357

Link

https://clinicaltrials.gov/show/NCT01839357

Keywords

Versions (1)
  1. 8/8/19 8/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01839357

English

Eligibility Atrial Fibrillation NCT01839357

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hemodynamically stable nonvalvular af or atrial flutter
Description

Atrial Fibrillation Stable status Hemodynamic | Atrial Flutter Stable status Hemodynamic

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0019010
UMLS CUI [2,1]
C0004239
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0019010
la/laa thrombus documented at baseline by transesophageal echocardiography (tee) up to 72 hours prior to start of study medication
Description

Thrombus of left atrium Transesophageal Echocardiography | Left Atrial Appendage Thrombus Transesophageal Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C3532827
UMLS CUI [1,2]
C0206054
UMLS CUI [2,1]
C4284918
UMLS CUI [2,2]
C0087086
UMLS CUI [2,3]
C0206054
vitamin k antagonist(s) (vka)/ new oral anticoagulant(s) (noac)-naïve or untreated within 1 month prior to signing of the informed consent form
Description

Vitamin K antagonists Absent | Oral anticoagulants Absent | Patients untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C3653316
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0354604
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0332155
vka pretreated but under ineffective inr levels(<2.0,documented with at least 2 consecutive measurements that are at least 24 hours apart) within last 6 weeks
Description

Vitamin K antagonists Pretreatment | INR Levels ineffective

Data type

boolean

Alias
UMLS CUI [1,1]
C3653316
UMLS CUI [1,2]
C3539076
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C0441889
UMLS CUI [2,3]
C3242229
women of childbearing potential and men must agree to use adequate contraception when sexually active
Description

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

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
transient ischemic attack within 3 days prior to study inclusion
Description

Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0007787
severe, disabling stroke (modified rankin score of 4-5, inclusive) within 3 months or any stroke within 14 days before the start of study drug
Description

Cerebrovascular accident Severely disabling Modified Rankin score | Cerebrovascular accident Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C4035398
UMLS CUI [1,3]
C3888574
UMLS CUI [2,1]
C0038454
UMLS CUI [2,2]
C1552551
acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to study inclusion
Description

Thromboembolism | Venous Thrombosis | Arterial thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2]
C0042487
UMLS CUI [3]
C0151942
acute myocardial infarction within the last 14 days prior to study inclusion
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
cardiac-related criteria: previous intracardiac thrombus, free-floating ball thrombus, intracardiac tumor, known left ventricular or aortic thrombus
Description

Criteria cardiac related | Thrombus of cardiac chamber | Ball thrombus Free-floating | Heart Neoplasm | Left ventricular thrombus | Thrombus aortic

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0439849
UMLS CUI [2]
C0876998
UMLS CUI [3,1]
C0333210
UMLS CUI [3,2]
C0443223
UMLS CUI [4]
C0018809
UMLS CUI [5]
C0587044
UMLS CUI [6,1]
C0087086
UMLS CUI [6,2]
C0003483
active bleeding or high risk for bleeding contraindicating anticoagulant therapy
Description

Hemorrhage | High risk of bleeding | Medical contraindication Anticoagulant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C4039184
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0150457
concomitant drugs/therapies: indication for anticoagulant therapy for a condition other than nonvalvular af or atrial flutter (eg, venous thromboembolism). concomitant use of anticoagulant drugs, including vka, or factor iia or factor xa inhibitors. chronic aspirin therapy >100 mg or dual antiplatelet therapy. concomitant use of strong inhibitors of both cytochrome p450 (cyp) 3a4 and p glycoprotein (p-gp), ie, all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents—ketoconazole, itraconazole, voriconazole, and posaconazole—if used systemically
Description

Indication Anticoagulant therapy | Condition Except Atrial Fibrillation | Condition Except Atrial Flutter | Venous Thromboembolism | Anticoagulants | Vitamin K Antagonist | Factor IIa Inhibitors | Factor Xa inhibitors | Aspirin therapy chronic Dosage | Antiplatelet therapy Dual | CYP3A4 Inhibitors Strong | P-Glycoprotein Inhibitors Strong | HIV Protease Inhibitors | ANTIMYCOTICS FOR SYSTEMIC USE | Ketoconazole | Itraconazole | voriconazole | posaconazole

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0150457
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0004238
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0332300
UMLS CUI [3,3]
C0004239
UMLS CUI [4]
C1861172
UMLS CUI [5]
C0003280
UMLS CUI [6]
C2267235
UMLS CUI [7,1]
C0060008
UMLS CUI [7,2]
C0243077
UMLS CUI [8]
C3669283
UMLS CUI [9,1]
C4303556
UMLS CUI [9,2]
C0205191
UMLS CUI [9,3]
C0178602
UMLS CUI [10,1]
C1096021
UMLS CUI [10,2]
C0205173
UMLS CUI [11,1]
C3850053
UMLS CUI [11,2]
C0442821
UMLS CUI [12,1]
C3500483
UMLS CUI [12,2]
C0442821
UMLS CUI [13]
C0162714
UMLS CUI [14]
C3653762
UMLS CUI [15]
C0022625
UMLS CUI [16]
C0064113
UMLS CUI [17]
C0393080
UMLS CUI [18]
C0936148
concomitant conditions: childbearing potential without proper contraceptive measures, pregnancy, or breast feeding. hypersensitivity to investigational treatment. calculated creatinine clearance (crcl) < 15 ml/minute at the screening visit. 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 3 months (eg, advanced malignancy, etc.). planned invasive procedure with potential for uncontrolled bleeding or increased risk of stroke, including major surgery, cardiac catheterization, or cardioversion prior to the end-of-treatment tee. inability to take oral medication. ongoing drug addiction or alcohol abuse
Description

Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding | Hypersensitivity Investigational Therapy | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver disease Associated with Blood Coagulation Disorders | Bleeding risk | Condition Severe Limiting Life Expectancy | Advanced cancer | Invasive procedure Planned | Bleeding uncontrolled | Risk Increased Cerebrovascular accident | Major surgery | Cardiac Catheterization | Electric Countershock | Lacking Able to swallow Oral medication | Drug Dependence | Alcohol abuse

Data type

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]
C2711451
UMLS CUI [6,1]
C0023895
UMLS CUI [6,2]
C0332281
UMLS CUI [6,3]
C0005779
UMLS CUI [7]
C3251812
UMLS CUI [8,1]
C0348080
UMLS CUI [8,2]
C0205082
UMLS CUI [8,3]
C0439801
UMLS CUI [8,4]
C0023671
UMLS CUI [9]
C0877373
UMLS CUI [10,1]
C4048276
UMLS CUI [10,2]
C1301732
UMLS CUI [11]
C3842135
UMLS CUI [12,1]
C0035647
UMLS CUI [12,2]
C0205217
UMLS CUI [12,3]
C0038454
UMLS CUI [13]
C0679637
UMLS CUI [14]
C0018795
UMLS CUI [15]
C0013778
UMLS CUI [16,1]
C0332268
UMLS CUI [16,2]
C2712086
UMLS CUI [16,3]
C0175795
UMLS CUI [17]
C1510472
UMLS CUI [18]
C0085762
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Similar models

Eligibility Atrial Fibrillation NCT01839357

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women aged >/= 18 years
boolean
C0001779 (UMLS CUI [1])
Atrial Fibrillation Stable status Hemodynamic | Atrial Flutter Stable status Hemodynamic
Item
hemodynamically stable nonvalvular af or atrial flutter
boolean
C0004238 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0019010 (UMLS CUI [1,3])
C0004239 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0019010 (UMLS CUI [2,3])
Thrombus of left atrium Transesophageal Echocardiography | Left Atrial Appendage Thrombus Transesophageal Echocardiography
Item
la/laa thrombus documented at baseline by transesophageal echocardiography (tee) up to 72 hours prior to start of study medication
boolean
C3532827 (UMLS CUI [1,1])
C0206054 (UMLS CUI [1,2])
C4284918 (UMLS CUI [2,1])
C0087086 (UMLS CUI [2,2])
C0206054 (UMLS CUI [2,3])
Vitamin K antagonists Absent | Oral anticoagulants Absent | Patients untreated
Item
vitamin k antagonist(s) (vka)/ new oral anticoagulant(s) (noac)-naïve or untreated within 1 month prior to signing of the informed consent form
boolean
C3653316 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0354604 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Vitamin K antagonists Pretreatment | INR Levels ineffective
Item
vka pretreated but under ineffective inr levels(<2.0,documented with at least 2 consecutive measurements that are at least 24 hours apart) within last 6 weeks
boolean
C3653316 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C3242229 (UMLS CUI [2,3])
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)
Transient Ischemic Attack
Item
transient ischemic attack within 3 days prior to study inclusion
boolean
C0007787 (UMLS CUI [1])
Cerebrovascular accident Severely disabling Modified Rankin score | Cerebrovascular accident Any
Item
severe, disabling stroke (modified rankin score of 4-5, inclusive) within 3 months or any stroke within 14 days before the start of study drug
boolean
C0038454 (UMLS CUI [1,1])
C4035398 (UMLS CUI [1,2])
C3888574 (UMLS CUI [1,3])
C0038454 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Thromboembolism | Venous Thrombosis | Arterial thrombosis
Item
acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to study inclusion
boolean
C0040038 (UMLS CUI [1])
C0042487 (UMLS CUI [2])
C0151942 (UMLS CUI [3])
Myocardial Infarction
Item
acute myocardial infarction within the last 14 days prior to study inclusion
boolean
C0027051 (UMLS CUI [1])
Criteria cardiac related | Thrombus of cardiac chamber | Ball thrombus Free-floating | Heart Neoplasm | Left ventricular thrombus | Thrombus aortic
Item
cardiac-related criteria: previous intracardiac thrombus, free-floating ball thrombus, intracardiac tumor, known left ventricular or aortic thrombus
boolean
C0243161 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0876998 (UMLS CUI [2])
C0333210 (UMLS CUI [3,1])
C0443223 (UMLS CUI [3,2])
C0018809 (UMLS CUI [4])
C0587044 (UMLS CUI [5])
C0087086 (UMLS CUI [6,1])
C0003483 (UMLS CUI [6,2])
Hemorrhage | High risk of bleeding | Medical contraindication Anticoagulant therapy
Item
active bleeding or high risk for bleeding contraindicating anticoagulant therapy
boolean
C0019080 (UMLS CUI [1])
C4039184 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0150457 (UMLS CUI [3,2])
Indication Anticoagulant therapy | Condition Except Atrial Fibrillation | Condition Except Atrial Flutter | Venous Thromboembolism | Anticoagulants | Vitamin K Antagonist | Factor IIa Inhibitors | Factor Xa inhibitors | Aspirin therapy chronic Dosage | Antiplatelet therapy Dual | CYP3A4 Inhibitors Strong | P-Glycoprotein Inhibitors Strong | HIV Protease Inhibitors | ANTIMYCOTICS FOR SYSTEMIC USE | Ketoconazole | Itraconazole | voriconazole | posaconazole
Item
concomitant drugs/therapies: indication for anticoagulant therapy for a condition other than nonvalvular af or atrial flutter (eg, venous thromboembolism). concomitant use of anticoagulant drugs, including vka, or factor iia or factor xa inhibitors. chronic aspirin therapy >100 mg or dual antiplatelet therapy. concomitant use of strong inhibitors of both cytochrome p450 (cyp) 3a4 and p glycoprotein (p-gp), ie, all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents—ketoconazole, itraconazole, voriconazole, and posaconazole—if used systemically
boolean
C3146298 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C0004239 (UMLS CUI [3,3])
C1861172 (UMLS CUI [4])
C0003280 (UMLS CUI [5])
C2267235 (UMLS CUI [6])
C0060008 (UMLS CUI [7,1])
C0243077 (UMLS CUI [7,2])
C3669283 (UMLS CUI [8])
C4303556 (UMLS CUI [9,1])
C0205191 (UMLS CUI [9,2])
C0178602 (UMLS CUI [9,3])
C1096021 (UMLS CUI [10,1])
C0205173 (UMLS CUI [10,2])
C3850053 (UMLS CUI [11,1])
C0442821 (UMLS CUI [11,2])
C3500483 (UMLS CUI [12,1])
C0442821 (UMLS CUI [12,2])
C0162714 (UMLS CUI [13])
C3653762 (UMLS CUI [14])
C0022625 (UMLS CUI [15])
C0064113 (UMLS CUI [16])
C0393080 (UMLS CUI [17])
C0936148 (UMLS CUI [18])
Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding | Hypersensitivity Investigational Therapy | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver disease Associated with Blood Coagulation Disorders | Bleeding risk | Condition Severe Limiting Life Expectancy | Advanced cancer | Invasive procedure Planned | Bleeding uncontrolled | Risk Increased Cerebrovascular accident | Major surgery | Cardiac Catheterization | Electric Countershock | 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. calculated creatinine clearance (crcl) < 15 ml/minute at the screening visit. 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 3 months (eg, advanced malignancy, etc.). planned invasive procedure with potential for uncontrolled bleeding or increased risk of stroke, including major surgery, cardiac catheterization, or cardioversion prior to the end-of-treatment tee. 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])
C2711451 (UMLS CUI [5])
C0023895 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C0005779 (UMLS CUI [6,3])
C3251812 (UMLS CUI [7])
C0348080 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0439801 (UMLS CUI [8,3])
C0023671 (UMLS CUI [8,4])
C0877373 (UMLS CUI [9])
C4048276 (UMLS CUI [10,1])
C1301732 (UMLS CUI [10,2])
C3842135 (UMLS CUI [11])
C0035647 (UMLS CUI [12,1])
C0205217 (UMLS CUI [12,2])
C0038454 (UMLS CUI [12,3])
C0679637 (UMLS CUI [13])
C0018795 (UMLS CUI [14])
C0013778 (UMLS CUI [15])
C0332268 (UMLS CUI [16,1])
C2712086 (UMLS CUI [16,2])
C0175795 (UMLS CUI [16,3])
C1510472 (UMLS CUI [17])
C0085762 (UMLS CUI [18])
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