ID

28752

Description

Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I; ODM derived from: https://clinicaltrials.gov/show/NCT00684359

Link

https://clinicaltrials.gov/show/NCT00684359

Keywords

Versions (1)
  1. 2/1/18 2/1/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 1, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00684359

English

Eligibility Coronary Disease NCT00684359

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients, male or female, > 18 years of age,
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients who are scheduled for an elective pci with a drug eluting stent
Description

Percutaneous Coronary Intervention elective Scheduled | PCI Drug-Eluting Stent

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0439608
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C1322815
patients willing to return for all required follow up visits.
Description

Follow-up visit Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C0600109
patients live/work within a 60 mile radius of the washington hospital center.
Description

Residence Nearby Hospital | Working Nearby Hospital

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C1706276
UMLS CUI [1,3]
C0019994
UMLS CUI [2,1]
C0043227
UMLS CUI [2,2]
C1706276
UMLS CUI [2,3]
C0019994
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has experienced an acute myocardial infarction within the preceding 48 hours of the subsequent angioplasty.
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
unprotected left main coronary disease with >50% stenosis;
Description

Left main coronary artery disease Without Protection | Stenosis Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1299433
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C1545588
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0439165
patients with renal failure requiring dialysis;
Description

Kidney Failure Requirement Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
patients with a documented ejection fraction < 30 percent at the time of subsequent pci;
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
patient with a life expectancy less than 12 months or malignancy.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
known allergies to aspirin or clopidogrel bisulfate (plavixr) and that cannot be medically managed;
Description

Aspirin allergy | Hypersensitivity Clopidogrel bisulfate | Hypersensitivity Plavix | Allergy prophylaxis Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0772326
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0633084
UMLS CUI [4,1]
C1737226
UMLS CUI [4,2]
C1272705
planned surgery or other indication for requiring the cessation of clopidogrel within 12 months of pci;
Description

Operative Surgical Procedures Planned | Clopidogrel To be stopped | Indication Clopidogrel To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0070166
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0070166
UMLS CUI [3,3]
C1272691
any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
Description

Medical condition Interferes with Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
patients with known history of bleeding diathesis;
Description

Bleeding tendency

Data type

boolean

Alias
UMLS CUI [1]
C1458140
prothrombin time >1.5 times control; coumadin therapy
Description

Prothrombin time increased | Coumadin

Data type

boolean

Alias
UMLS CUI [1]
C0151872
UMLS CUI [2]
C0699129
platelet count <100 000/mm3;
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
hematocrit <25%;
Description

Hematocrit procedure

Data type

boolean

Alias
UMLS CUI [1]
C0018935
creatinine >4.0 mg/dl;
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
thienopyridine use within 5 days of enrollment
Description

thienopyridine

Data type

boolean

Alias
UMLS CUI [1]
C1120149
glycoprotein (gp) iib/iiia use within 8 hours of enrollment or any indication were the operator will require gp iib/iiia inhibitor use during the hospitalization.
Description

Glycoprotein GPIIb-IIIa | Patient need for Platelet Glycoprotein IIb/IIIA Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0016011
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1373125
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Similar models

Eligibility Coronary Disease NCT00684359

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients, male or female, > 18 years of age,
boolean
C0001779 (UMLS CUI [1])
Percutaneous Coronary Intervention elective Scheduled | PCI Drug-Eluting Stent
Item
patients who are scheduled for an elective pci with a drug eluting stent
boolean
C1532338 (UMLS CUI [1,1])
C0439608 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C1532338 (UMLS CUI [2,1])
C1322815 (UMLS CUI [2,2])
Follow-up visit Willing
Item
patients willing to return for all required follow up visits.
boolean
C0589121 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Residence Nearby Hospital | Working Nearby Hospital
Item
patients live/work within a 60 mile radius of the washington hospital center.
boolean
C0237096 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,3])
C0043227 (UMLS CUI [2,1])
C1706276 (UMLS CUI [2,2])
C0019994 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction
Item
patient has experienced an acute myocardial infarction within the preceding 48 hours of the subsequent angioplasty.
boolean
C0027051 (UMLS CUI [1])
Left main coronary artery disease Without Protection | Stenosis Percentage
Item
unprotected left main coronary disease with >50% stenosis;
boolean
C1299433 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C1545588 (UMLS CUI [1,3])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Kidney Failure Requirement Dialysis
Item
patients with renal failure requiring dialysis;
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
Cardiac ejection fraction
Item
patients with a documented ejection fraction < 30 percent at the time of subsequent pci;
boolean
C0232174 (UMLS CUI [1])
Life Expectancy
Item
patient with a life expectancy less than 12 months or malignancy.
boolean
C0023671 (UMLS CUI [1])
Aspirin allergy | Hypersensitivity Clopidogrel bisulfate | Hypersensitivity Plavix | Allergy prophylaxis Unsuccessful
Item
known allergies to aspirin or clopidogrel bisulfate (plavixr) and that cannot be medically managed;
boolean
C0004058 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0772326 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0633084 (UMLS CUI [3,2])
C1737226 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
Operative Surgical Procedures Planned | Clopidogrel To be stopped | Indication Clopidogrel To be stopped
Item
planned surgery or other indication for requiring the cessation of clopidogrel within 12 months of pci;
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0070166 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C1272691 (UMLS CUI [3,3])
Medical condition Interferes with Study Subject Participation Status
Item
any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Bleeding tendency
Item
patients with known history of bleeding diathesis;
boolean
C1458140 (UMLS CUI [1])
Prothrombin time increased | Coumadin
Item
prothrombin time >1.5 times control; coumadin therapy
boolean
C0151872 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
Platelet Count measurement
Item
platelet count <100 000/mm3;
boolean
C0032181 (UMLS CUI [1])
Hematocrit procedure
Item
hematocrit <25%;
boolean
C0018935 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine >4.0 mg/dl;
boolean
C0201976 (UMLS CUI [1])
thienopyridine
Item
thienopyridine use within 5 days of enrollment
boolean
C1120149 (UMLS CUI [1])
Glycoprotein GPIIb-IIIa | Patient need for Platelet Glycoprotein IIb/IIIA Inhibitors
Item
glycoprotein (gp) iib/iiia use within 8 hours of enrollment or any indication were the operator will require gp iib/iiia inhibitor use during the hospitalization.
boolean
C0016011 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C1373125 (UMLS CUI [2,2])
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