ID

37575

Descripción

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

Palabras clave

Versiones (1)
  1. 8/8/19 8/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de agosto de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Atrial Fibrillation NCT01839357

Inglés

Eligibility Atrial Fibrillation NCT01839357

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

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

Atrial Fibrillation Stable status Hemodynamic | Atrial Flutter Stable status Hemodynamic

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Vitamin K antagonists Absent | Oral anticoagulants Absent | Patients untreated

Tipo de datos

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
Descripción

Vitamin K antagonists Pretreatment | INR Levels ineffective

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Exclusion Criteria

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

Transient Ischemic Attack

Tipo de datos

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
Descripción

Cerebrovascular accident Severely disabling Modified Rankin score | Cerebrovascular accident Any

Tipo de datos

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
Descripción

Thromboembolism | Venous Thrombosis | Arterial thrombosis

Tipo de datos

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
Descripción

Myocardial Infarction

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

Hemorrhage | High risk of bleeding | Medical contraindication Anticoagulant therapy

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Volver a la parte superior de la página

Similar models

Eligibility Atrial Fibrillation NCT01839357

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial