ID

37654

Beschrijving

Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI); ODM derived from: https://clinicaltrials.gov/show/NCT02164864

Link

https://clinicaltrials.gov/show/NCT02164864

Trefwoorden

Versies (1)
  1. 14-08-19 14-08-19 -
Houder van rechten

See clinicaltrials.gov

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14 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02164864

Engels

Eligibility Atrial Fibrillation NCT02164864

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged >=18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with non valvular atrial fibrillation
Beschrijving

Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0004238
patient presenting with:
Beschrijving

Patient Finding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0243095
an acs (stemi, nonstemi [nstemi] or unstable angina [ua]) that was successfully treated by pci and stenting (either bare metal stent or drug eluting stent) or stable coronary artery disease with at least one lesion eligible for pci that was successfully treated by elective pci and stenting (either bms or des)
Beschrijving

Acute Coronary Syndrome | ST segment elevation myocardial infarction | Non-ST elevation (NSTEMI) myocardial infarction | Angina, Unstable | Percutaneous Coronary Intervention | Stenting Bare metal stent | Stenting Drug-Eluting Stents | Coronary Artery Disease Stable | Lesion Quantity Eligible PCI

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C1536220
UMLS CUI [3]
C1561921
UMLS CUI [4]
C0002965
UMLS CUI [5]
C1532338
UMLS CUI [6,1]
C2348535
UMLS CUI [6,2]
C2825200
UMLS CUI [7,1]
C2348535
UMLS CUI [7,2]
C1322815
UMLS CUI [8,1]
C1956346
UMLS CUI [8,2]
C0205360
UMLS CUI [9,1]
C0221198
UMLS CUI [9,2]
C1265611
UMLS CUI [9,3]
C1548635
UMLS CUI [9,4]
C1532338
the patient must be able to give informed consent in accordance with international conference on harmonisation good clinical practice guidelines and local legislation and/or regulations.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a mechanical or biological heart valve prosthesis
Beschrijving

Mechanical heart valve prosthesis | Heart Valve Prosthesis biological

Datatype

boolean

Alias
UMLS CUI [1]
C3873910
UMLS CUI [2,1]
C0018825
UMLS CUI [2,2]
C0205460
cardiogenic shock during current hospitalisation
Beschrijving

Shock, Cardiogenic

Datatype

boolean

Alias
UMLS CUI [1]
C0036980
stroke within 1 month prior to screening visit
Beschrijving

Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
patients who have had major surgery within the month prior to screening
Beschrijving

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the investigator, the cause has been permanently eliminated
Beschrijving

Gastrointestinal Hemorrhage | Exception Cause eliminated

Datatype

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0849355
major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
Beschrijving

Hemorrhage Episode Major | Hemorrhage Episode Life Threatening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0205164
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C2826244
anaemia (haemoglobin <10g/dl) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/l) at screening
Beschrijving

Anemia | Hemoglobin measurement | Thrombocytopenia | Heparin-induced thrombocytopenia | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0040034
UMLS CUI [4]
C0272285
UMLS CUI [5]
C0032181
severe renal impairment (estimated crcl calculated by cockcroft-gault equation) <30ml/min at screening
Beschrijving

Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2711451
active liver disease
Beschrijving

Liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
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Similar models

Eligibility Atrial Fibrillation NCT02164864

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients aged >=18 years
boolean
C0001779 (UMLS CUI [1])
Atrial Fibrillation
Item
patients with non valvular atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Patient Finding
Item
patient presenting with:
boolean
C0030705 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Acute Coronary Syndrome | ST segment elevation myocardial infarction | Non-ST elevation (NSTEMI) myocardial infarction | Angina, Unstable | Percutaneous Coronary Intervention | Stenting Bare metal stent | Stenting Drug-Eluting Stents | Coronary Artery Disease Stable | Lesion Quantity Eligible PCI
Item
an acs (stemi, nonstemi [nstemi] or unstable angina [ua]) that was successfully treated by pci and stenting (either bare metal stent or drug eluting stent) or stable coronary artery disease with at least one lesion eligible for pci that was successfully treated by elective pci and stenting (either bms or des)
boolean
C0948089 (UMLS CUI [1])
C1536220 (UMLS CUI [2])
C1561921 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C1532338 (UMLS CUI [5])
C2348535 (UMLS CUI [6,1])
C2825200 (UMLS CUI [6,2])
C2348535 (UMLS CUI [7,1])
C1322815 (UMLS CUI [7,2])
C1956346 (UMLS CUI [8,1])
C0205360 (UMLS CUI [8,2])
C0221198 (UMLS CUI [9,1])
C1265611 (UMLS CUI [9,2])
C1548635 (UMLS CUI [9,3])
C1532338 (UMLS CUI [9,4])
Informed Consent
Item
the patient must be able to give informed consent in accordance with international conference on harmonisation good clinical practice guidelines and local legislation and/or regulations.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mechanical heart valve prosthesis | Heart Valve Prosthesis biological
Item
patients with a mechanical or biological heart valve prosthesis
boolean
C3873910 (UMLS CUI [1])
C0018825 (UMLS CUI [2,1])
C0205460 (UMLS CUI [2,2])
Shock, Cardiogenic
Item
cardiogenic shock during current hospitalisation
boolean
C0036980 (UMLS CUI [1])
Cerebrovascular accident
Item
stroke within 1 month prior to screening visit
boolean
C0038454 (UMLS CUI [1])
Major surgery
Item
patients who have had major surgery within the month prior to screening
boolean
C0679637 (UMLS CUI [1])
Gastrointestinal Hemorrhage | Exception Cause eliminated
Item
gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the investigator, the cause has been permanently eliminated
boolean
C0017181 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0849355 (UMLS CUI [2,3])
Hemorrhage Episode Major | Hemorrhage Episode Life Threatening
Item
major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
boolean
C0019080 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0019080 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C2826244 (UMLS CUI [2,3])
Anemia | Hemoglobin measurement | Thrombocytopenia | Heparin-induced thrombocytopenia | Platelet Count measurement
Item
anaemia (haemoglobin <10g/dl) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/l) at screening
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0040034 (UMLS CUI [3])
C0272285 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
severe renal impairment (estimated crcl calculated by cockcroft-gault equation) <30ml/min at screening
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2711451 (UMLS CUI [2])
Liver disease
Item
active liver disease
boolean
C0023895 (UMLS CUI [1])
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