ID

37573

Beschrijving

A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention; ODM derived from: https://clinicaltrials.gov/show/NCT01830543

Link

https://clinicaltrials.gov/show/NCT01830543

Trefwoorden

Versies (1)
  1. 08-08-19 08-08-19 -
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See clinicaltrials.gov

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8 augustus 2019

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01830543

Engels

Eligibility Atrial Fibrillation NCT01830543

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a documented medical history of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (af)
Beschrijving

Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3]
C2586056
have undergone percutaneous coronary intervention (pci) procedure (with stent placement) for primary atherosclerotic disease
Beschrijving

Percutaneous Coronary Intervention Atherosclerosis | Placement of stent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0004153
UMLS CUI [2]
C0522776
must have an international normalized ratio (inr) of 2.5 or below to be randomized
Beschrijving

International Normalized Ratio

Datatype

boolean

Alias
UMLS CUI [1]
C0525032
women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active
Beschrijving

Postmenopausal state | Gender Sexually active Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
be willing and able to adhere to the prohibitions and restrictions specified in the study protocol
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
have any condition that contraindicates anticoagulant or antiplatelet therapy or would have an unacceptable risk of bleeding, such as, but not limited to: platelet count <90,000/microliter at screening, history of intracranial hemorrhage, 12 month history of clinically significant gastrointestinal bleeding, non-vka induced elevated prothrombin time (pt) at screening
Beschrijving

Condition Contraindicated Anticoagulant therapy | Condition Contraindicated Antiplatelet therapy | Bleeding risk Unacceptable | Platelet Count measurement | Intracranial Hemorrhage | Gastrointestinal Hemorrhage Disease length | Elevated prothrombin time Independent of Vitamin K Antagonist

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0150457
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444657
UMLS CUI [2,3]
C1096021
UMLS CUI [3,1]
C3251812
UMLS CUI [3,2]
C1883420
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0151699
UMLS CUI [6,1]
C0017181
UMLS CUI [6,2]
C0872146
UMLS CUI [7,1]
C2674387
UMLS CUI [7,2]
C0332291
UMLS CUI [7,3]
C2267235
have anemia of unknown cause with a hemoglobin level <10 g/dl (<6.21 mmol/l)
Beschrijving

Anemia Cause Unknown | Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0439673
UMLS CUI [2]
C0518015
have a history of stroke or transient ischemic attack (tia)
Beschrijving

Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
have a calculated creatinine clearance (crcl) <30 ml/min at screening
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
have known significant liver disease or liver function test (lft) abnormalities
Beschrijving

Liver disease | Liver function tests abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151766
have any severe condition that would limit life expectancy to less than 12 months
Beschrijving

Condition Severe Limiting Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0023671
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Similar models

Eligibility Atrial Fibrillation NCT01830543

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation
Item
have a documented medical history of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (af)
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C2586056 (UMLS CUI [3])
Percutaneous Coronary Intervention Atherosclerosis | Placement of stent
Item
have undergone percutaneous coronary intervention (pci) procedure (with stent placement) for primary atherosclerotic disease
boolean
C1532338 (UMLS CUI [1,1])
C0004153 (UMLS CUI [1,2])
C0522776 (UMLS CUI [2])
International Normalized Ratio
Item
must have an international normalized ratio (inr) of 2.5 or below to be randomized
boolean
C0525032 (UMLS CUI [1])
Postmenopausal state | Gender Sexually active Contraceptive methods
Item
women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active
boolean
C0232970 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Protocol Compliance
Item
be willing and able to adhere to the prohibitions and restrictions specified in the study protocol
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Condition Contraindicated Anticoagulant therapy | Condition Contraindicated Antiplatelet therapy | Bleeding risk Unacceptable | Platelet Count measurement | Intracranial Hemorrhage | Gastrointestinal Hemorrhage Disease length | Elevated prothrombin time Independent of Vitamin K Antagonist
Item
have any condition that contraindicates anticoagulant or antiplatelet therapy or would have an unacceptable risk of bleeding, such as, but not limited to: platelet count <90,000/microliter at screening, history of intracranial hemorrhage, 12 month history of clinically significant gastrointestinal bleeding, non-vka induced elevated prothrombin time (pt) at screening
boolean
C0348080 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0150457 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
C1096021 (UMLS CUI [2,3])
C3251812 (UMLS CUI [3,1])
C1883420 (UMLS CUI [3,2])
C0032181 (UMLS CUI [4])
C0151699 (UMLS CUI [5])
C0017181 (UMLS CUI [6,1])
C0872146 (UMLS CUI [6,2])
C2674387 (UMLS CUI [7,1])
C0332291 (UMLS CUI [7,2])
C2267235 (UMLS CUI [7,3])
Anemia Cause Unknown | Hemoglobin measurement
Item
have anemia of unknown cause with a hemoglobin level <10 g/dl (<6.21 mmol/l)
boolean
C0002871 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0518015 (UMLS CUI [2])
Cerebrovascular accident | Transient Ischemic Attack
Item
have a history of stroke or transient ischemic attack (tia)
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
have a calculated creatinine clearance (crcl) <30 ml/min at screening
boolean
C2711451 (UMLS CUI [1])
Liver disease | Liver function tests abnormal
Item
have known significant liver disease or liver function test (lft) abnormalities
boolean
C0023895 (UMLS CUI [1])
C0151766 (UMLS CUI [2])
Condition Severe Limiting Life Expectancy
Item
have any severe condition that would limit life expectancy to less than 12 months
boolean
C0348080 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0023671 (UMLS CUI [1,4])
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