ID

28723

Beschrijving

Pilot Study on the Effect of High Clopidogrel Maintenance Dosing; ODM derived from: https://clinicaltrials.gov/show/NCT01118793

Link

https://clinicaltrials.gov/show/NCT01118793

Trefwoorden

Versies (1)
  1. 28-01-18 28-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT01118793

Engels

Eligibility Coronary Artery Disease NCT01118793

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and non-pregnant females between the ages of 18-85.
Beschrijving

Gender | Pregnancy Absent | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0001779
patients able to give informed written consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients on clopidogrel for ≥ 7 days.
Beschrijving

Clopidogrel

Datatype

boolean

Alias
UMLS CUI [1]
C0070166
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in a study of experimental therapy or device within prior 30 days.
Beschrijving

Study Subject Participation Status | Therapy, Investigational | Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
UMLS CUI [3]
C2346570
pregnant women or women of childbearing potential not using an acceptable method of contraception who have not been proven to have a negative pregnancy test result.
Beschrijving

Pregnancy | Childbearing Potential Contraceptive methods Absent | Pregnancy test negative Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0427780
UMLS CUI [3,2]
C0332197
inability to comply with all aspects of the protocol.
Beschrijving

Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
history of bleeding diathesis or evidence of active abnormal bleeding within previous 90 days.
Beschrijving

Abnormal bleeding

Datatype

boolean

Alias
UMLS CUI [1]
C1458140
severe hypertension (systolic blood pressure > 200 mm hg or diastolic blood pressure > 110 mm hg) not adequately controlled on antihypertensive therapy.
Beschrijving

Hypertension, severe | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy Inadequate

Datatype

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0585941
UMLS CUI [4,2]
C0205412
major surgery within the preceding 6 weeks.
Beschrijving

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
history of stroke within 30 days or any history of hemorrhagic stroke.
Beschrijving

Cerebrovascular accident | Hemorrhagic stroke

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0553692
history of intracranial neoplasm.
Beschrijving

Neoplasms, Intracranial

Datatype

boolean

Alias
UMLS CUI [1]
C1527390
current or planned administration of another parenteral gp iib-iiia inhibitor within 7 days of enrollment.
Beschrijving

Injection or infusion of GP IIB-IIIa inhibitor Parenteral | Injection or infusion of GP IIB-IIIa inhibitor Parenteral Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0864559
UMLS CUI [1,2]
C1518896
UMLS CUI [2,1]
C0864559
UMLS CUI [2,2]
C1518896
UMLS CUI [2,3]
C1301732
known hypersensitivity to any component of the product.
Beschrijving

Hypersensitivity Product Component

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1514468
UMLS CUI [1,3]
C1705248
unstable angina with dynamic st or t wave changes within 48 hours of enrollment.
Beschrijving

Angina, Unstable | ST segment changes Dynamic | T wave Change Dynamic

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0232326
UMLS CUI [2,2]
C0729333
UMLS CUI [3,1]
C0429104
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0729333
administration of lmwh within 8 hours prior to enrollment or ufh within 60 minutes unless a ppt < 50 secs or act < 150 secs.
Beschrijving

Heparin, Low-Molecular-Weight | Unfractionated Heparin | Exception Activated Partial Thromboplastin Time measurement | Exception Activated clotting time measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0019139
UMLS CUI [2]
C2825026
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0030605
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0427611
on chronic anticoagulation (i.e. coumadin).
Beschrijving

Chronic anticoagulation | Coumadin

Datatype

boolean

Alias
UMLS CUI [1]
C0694554
UMLS CUI [2]
C0699129
hemoglobin < 10 g/dl.
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
hematocrit < 30%.
Beschrijving

Hematocrit procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0018935
platelet count < 100,000 mcl.
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
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Similar models

Eligibility Coronary Artery Disease NCT01118793

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Pregnancy Absent | Age
Item
males and non-pregnant females between the ages of 18-85.
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
Informed Consent
Item
patients able to give informed written consent.
boolean
C0021430 (UMLS CUI [1])
Clopidogrel
Item
patients on clopidogrel for ≥ 7 days.
boolean
C0070166 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Therapy, Investigational | Investigational Medical Device
Item
participation in a study of experimental therapy or device within prior 30 days.
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Pregnancy | Childbearing Potential Contraceptive methods Absent | Pregnancy test negative Absent
Item
pregnant women or women of childbearing potential not using an acceptable method of contraception who have not been proven to have a negative pregnancy test result.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0427780 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Protocol Compliance Unable
Item
inability to comply with all aspects of the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Abnormal bleeding
Item
history of bleeding diathesis or evidence of active abnormal bleeding within previous 90 days.
boolean
C1458140 (UMLS CUI [1])
Hypertension, severe | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy Inadequate
Item
severe hypertension (systolic blood pressure > 200 mm hg or diastolic blood pressure > 110 mm hg) not adequately controlled on antihypertensive therapy.
boolean
C4013784 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0585941 (UMLS CUI [4,1])
C0205412 (UMLS CUI [4,2])
Major surgery
Item
major surgery within the preceding 6 weeks.
boolean
C0679637 (UMLS CUI [1])
Cerebrovascular accident | Hemorrhagic stroke
Item
history of stroke within 30 days or any history of hemorrhagic stroke.
boolean
C0038454 (UMLS CUI [1])
C0553692 (UMLS CUI [2])
Neoplasms, Intracranial
Item
history of intracranial neoplasm.
boolean
C1527390 (UMLS CUI [1])
Injection or infusion of GP IIB-IIIa inhibitor Parenteral | Injection or infusion of GP IIB-IIIa inhibitor Parenteral Planned
Item
current or planned administration of another parenteral gp iib-iiia inhibitor within 7 days of enrollment.
boolean
C0864559 (UMLS CUI [1,1])
C1518896 (UMLS CUI [1,2])
C0864559 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Hypersensitivity Product Component
Item
known hypersensitivity to any component of the product.
boolean
C0020517 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Angina, Unstable | ST segment changes Dynamic | T wave Change Dynamic
Item
unstable angina with dynamic st or t wave changes within 48 hours of enrollment.
boolean
C0002965 (UMLS CUI [1])
C0232326 (UMLS CUI [2,1])
C0729333 (UMLS CUI [2,2])
C0429104 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0729333 (UMLS CUI [3,3])
Heparin, Low-Molecular-Weight | Unfractionated Heparin | Exception Activated Partial Thromboplastin Time measurement | Exception Activated clotting time measurement
Item
administration of lmwh within 8 hours prior to enrollment or ufh within 60 minutes unless a ppt < 50 secs or act < 150 secs.
boolean
C0019139 (UMLS CUI [1])
C2825026 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0030605 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0427611 (UMLS CUI [4,2])
Chronic anticoagulation | Coumadin
Item
on chronic anticoagulation (i.e. coumadin).
boolean
C0694554 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
Hemoglobin measurement
Item
hemoglobin < 10 g/dl.
boolean
C0518015 (UMLS CUI [1])
Hematocrit procedure
Item
hematocrit < 30%.
boolean
C0018935 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 100,000 mcl.
boolean
C0032181 (UMLS CUI [1])
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