ID

28484

Beskrivning

Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting; ODM derived from: https://clinicaltrials.gov/show/NCT00661206

Länk

https://clinicaltrials.gov/show/NCT00661206

Nyckelord

Versioner (1)
  1. 2018-01-17 2018-01-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 januari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00661206

Engelsk

Eligibility Coronary Artery Disease NCT00661206

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients on clopidogrel therapy at 6 months (-1/+2 months) after des implantation
Beskrivning

clopidogrel | Drug-Eluting Stent Implantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0070166
UMLS CUI [2,1]
C1322815
UMLS CUI [2,2]
C0021107
informed, written consent by the patient
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
age ≤18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization
Beskrivning

Symptoms Clinical Ischemia | Coronary Lesion by Angiographic Finding Requirement Revascularization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0022116
UMLS CUI [2,1]
C3899494
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0581603
previous stent thrombosis
Beskrivning

Stent thrombosis

Datatyp

boolean

Alias
UMLS CUI [1]
C3897493
des in left main coronary artery
Beskrivning

Drug-Eluting Stent Left coronary artery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1322815
UMLS CUI [1,2]
C1261082
st-elevation and non-st-elevation myocardial infarction during the last 6 months
Beskrivning

ST segment elevation myocardial infarction | Non-ST elevation (NSTEMI) myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C1536220
UMLS CUI [2]
C1561921
malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance
Beskrivning

Malignant Neoplasms | Comorbidity | Life Expectancy | Malignant Neoplasms Protocol Compliance Lacking | Comorbidity Protocol Compliance Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0009488
UMLS CUI [3]
C0023671
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0332268
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C0525058
UMLS CUI [5,3]
C0332268
planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
Beskrivning

Major surgery Planned | Antiplatelet therapy To be stopped

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1096021
UMLS CUI [2,2]
C1272691
active bleeding; bleeding diathesis; history intracranial bleeding
Beskrivning

Hemorrhage | Bleeding tendency | Intracranial Hemorrhages

Datatyp

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C1458140
UMLS CUI [3]
C0151699
oral anticoagulation therapy with coumadin derivatives
Beskrivning

Anticoagulation Therapy Oral | Coumadin derivatives

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0699129
UMLS CUI [2,2]
C0243072
known allergy or intolerance to the study medications: aspirin and clopidogrel
Beskrivning

Hypersensitivity Investigational New Drugs | Intolerance to Investigational New Drugs | Aspirin allergy | Intolerance to Aspirin | Hypersensitivity clopidogrel | Intolerance to clopidogrel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
UMLS CUI [3]
C0004058
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0004057
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0070166
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0070166
pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)
Beskrivning

Pregnancy | Pregnancy Suspected | Pregnancy, Planned | Pregnancy test positive | Childbearing Potential Requirement Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0240802
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0427780
patient's inability to fully comply with the study protocol
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
prior enrollment in the same clinical trial.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Coronary Artery Disease NCT00661206

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
clopidogrel | Drug-Eluting Stent Implantation
Item
patients on clopidogrel therapy at 6 months (-1/+2 months) after des implantation
boolean
C0070166 (UMLS CUI [1])
C1322815 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
Informed Consent
Item
informed, written consent by the patient
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
age ≤18 years
boolean
C0001779 (UMLS CUI [1])
Symptoms Clinical Ischemia | Coronary Lesion by Angiographic Finding Requirement Revascularization
Item
clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization
boolean
C1457887 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0022116 (UMLS CUI [1,3])
C3899494 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0581603 (UMLS CUI [2,3])
Stent thrombosis
Item
previous stent thrombosis
boolean
C3897493 (UMLS CUI [1])
Drug-Eluting Stent Left coronary artery
Item
des in left main coronary artery
boolean
C1322815 (UMLS CUI [1,1])
C1261082 (UMLS CUI [1,2])
ST segment elevation myocardial infarction | Non-ST elevation (NSTEMI) myocardial infarction
Item
st-elevation and non-st-elevation myocardial infarction during the last 6 months
boolean
C1536220 (UMLS CUI [1])
C1561921 (UMLS CUI [2])
Malignant Neoplasms | Comorbidity | Life Expectancy | Malignant Neoplasms Protocol Compliance Lacking | Comorbidity Protocol Compliance Lacking
Item
malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance
boolean
C0006826 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
C0006826 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
C0009488 (UMLS CUI [5,1])
C0525058 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
Major surgery Planned | Antiplatelet therapy To be stopped
Item
planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
boolean
C0679637 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1096021 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Hemorrhage | Bleeding tendency | Intracranial Hemorrhages
Item
active bleeding; bleeding diathesis; history intracranial bleeding
boolean
C0019080 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C0151699 (UMLS CUI [3])
Anticoagulation Therapy Oral | Coumadin derivatives
Item
oral anticoagulation therapy with coumadin derivatives
boolean
C0003281 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0699129 (UMLS CUI [2,1])
C0243072 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Intolerance to Investigational New Drugs | Aspirin allergy | Intolerance to Aspirin | Hypersensitivity clopidogrel | Intolerance to clopidogrel
Item
known allergy or intolerance to the study medications: aspirin and clopidogrel
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0004058 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0004057 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0070166 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0070166 (UMLS CUI [6,2])
Pregnancy | Pregnancy Suspected | Pregnancy, Planned | Pregnancy test positive | Childbearing Potential Requirement Pregnancy test negative
Item
pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3])
C0240802 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0427780 (UMLS CUI [5,3])
Protocol Compliance Unable
Item
patient's inability to fully comply with the study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status
Item
prior enrollment in the same clinical trial.
boolean
C2348568 (UMLS CUI [1])
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