ID

28454

Beskrivning

Antithrombotic Regimens and Outcome; ODM derived from: https://clinicaltrials.gov/show/NCT00448461

Länk

https://clinicaltrials.gov/show/NCT00448461

Nyckelord

Versioner (1)
  1. 2018-01-15 2018-01-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 januari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00448461

Engelsk

Eligibility Coronary Artery Disease NCT00448461

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients older than age 18 to undergo pci
Beskrivning

Age | Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1532338
2. pretreatment at least 6 hours before pci with clopidogrel according to the pci guidelines.
Beskrivning

clopidogrel | Pretreatment Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C0070166
UMLS CUI [2,1]
C3539076
UMLS CUI [2,2]
C1532338
3. informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
Beskrivning

Informed Consent | Informed Consent Patient Representative

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. recent st-elevation myocardial infarction within the last 48 hours.
Beskrivning

ST segment elevation myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C1536220
2. chronic coronary artery occlusion to be treated
Beskrivning

chronic total occlusion of coronary artery Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1955779
UMLS CUI [1,2]
C0332121
3. malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance.
Beskrivning

Malignant Neoplasms | Comorbidity | Liver disease Severe | Kidney Disease Severe | Pancreatic Disease Severe | Life Expectancy | Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0009488
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0030286
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0023671
UMLS CUI [7,1]
C0525058
UMLS CUI [7,2]
C1299582
4. active bleeding, bleeding diathesis, recent surgery (< 15 days)
Beskrivning

Hemorrhage | Bleeding tendency | Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C1458140
UMLS CUI [3]
C0543467
5. history of gastrointestinal or genitourinary bleeding within the last 6 weeks
Beskrivning

Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2]
C0919591
6. treatment with ufh within 6 hours or low-molecular weight heparin within 8 hours before randomization.
Beskrivning

Unfractionated Heparin | Heparin, Low-Molecular-Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C2825026
UMLS CUI [2]
C0019139
7. treatment with bivalirudin within 24 hours beforerandomization.
Beskrivning

bivalirudin

Datatyp

boolean

Alias
UMLS CUI [1]
C0168273
8. severe uncontrolled hypertension >180/110 mmhg unresponsive to therapy
Beskrivning

Uncontrolled hypertension Severe Unresponsive to Treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205269
9. relevant hematologic deviations: hemoglobin < 100 g/l or platelet count < 100 x 109
Beskrivning

Hematology finding abnormal | Hemoglobin measurement | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0475182
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
10. glomerular filtration rate (gfr) < 30 ml/min or serum creatinine > 30 mg/l or dependence on renal dialysis.
Beskrivning

Glomerular Filtration Rate | Creatinine measurement, serum | Dependence on renal dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0017654
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0524376
11. known allergy to the study medications: aspirin, clopidogrel, ufh, bivalirudin; stainless steel; true anaphylaxis after prior exposure to contrast media.
Beskrivning

Hypersensitivity Investigational New Drugs | Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Unfractionated Heparin | Hypersensitivity bivalirudin | Hypersensitivity Stainless Steel | Anaphylaxis Post Exposure to Contrast Media

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2]
C0004058
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C2825026
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0168273
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0038126
UMLS CUI [7,1]
C0002792
UMLS CUI [7,2]
C0687676
UMLS CUI [7,3]
C0332157
UMLS CUI [7,4]
C0009924
12. known heparin-induced thrombocytopenia
Beskrivning

Heparin-induced thrombocytopenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0272285
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Similar models

Eligibility Coronary Artery Disease NCT00448461

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Percutaneous Coronary Intervention
Item
1. patients older than age 18 to undergo pci
boolean
C0001779 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
clopidogrel | Pretreatment Percutaneous Coronary Intervention
Item
2. pretreatment at least 6 hours before pci with clopidogrel according to the pci guidelines.
boolean
C0070166 (UMLS CUI [1])
C3539076 (UMLS CUI [2,1])
C1532338 (UMLS CUI [2,2])
Informed Consent | Informed Consent Patient Representative
Item
3. informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
ST segment elevation myocardial infarction
Item
1. recent st-elevation myocardial infarction within the last 48 hours.
boolean
C1536220 (UMLS CUI [1])
chronic total occlusion of coronary artery Treatment required for
Item
2. chronic coronary artery occlusion to be treated
boolean
C1955779 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Malignant Neoplasms | Comorbidity | Liver disease Severe | Kidney Disease Severe | Pancreatic Disease Severe | Life Expectancy | Protocol Compliance Unable
Item
3. malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance.
boolean
C0006826 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0022658 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0030286 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0023671 (UMLS CUI [6])
C0525058 (UMLS CUI [7,1])
C1299582 (UMLS CUI [7,2])
Hemorrhage | Bleeding tendency | Operative Surgical Procedures
Item
4. active bleeding, bleeding diathesis, recent surgery (< 15 days)
boolean
C0019080 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage
Item
5. history of gastrointestinal or genitourinary bleeding within the last 6 weeks
boolean
C0017181 (UMLS CUI [1])
C0919591 (UMLS CUI [2])
Unfractionated Heparin | Heparin, Low-Molecular-Weight
Item
6. treatment with ufh within 6 hours or low-molecular weight heparin within 8 hours before randomization.
boolean
C2825026 (UMLS CUI [1])
C0019139 (UMLS CUI [2])
bivalirudin
Item
7. treatment with bivalirudin within 24 hours beforerandomization.
boolean
C0168273 (UMLS CUI [1])
Uncontrolled hypertension Severe Unresponsive to Treatment
Item
8. severe uncontrolled hypertension >180/110 mmhg unresponsive to therapy
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
Hematology finding abnormal | Hemoglobin measurement | Platelet Count measurement
Item
9. relevant hematologic deviations: hemoglobin < 100 g/l or platelet count < 100 x 109
boolean
C0475182 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Glomerular Filtration Rate | Creatinine measurement, serum | Dependence on renal dialysis
Item
10. glomerular filtration rate (gfr) < 30 ml/min or serum creatinine > 30 mg/l or dependence on renal dialysis.
boolean
C0017654 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0524376 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Unfractionated Heparin | Hypersensitivity bivalirudin | Hypersensitivity Stainless Steel | Anaphylaxis Post Exposure to Contrast Media
Item
11. known allergy to the study medications: aspirin, clopidogrel, ufh, bivalirudin; stainless steel; true anaphylaxis after prior exposure to contrast media.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0004058 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C2825026 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0168273 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0038126 (UMLS CUI [6,2])
C0002792 (UMLS CUI [7,1])
C0687676 (UMLS CUI [7,2])
C0332157 (UMLS CUI [7,3])
C0009924 (UMLS CUI [7,4])
Heparin-induced thrombocytopenia
Item
12. known heparin-induced thrombocytopenia
boolean
C0272285 (UMLS CUI [1])
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