ID

34183

Description

The Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01975376

Link

https://clinicaltrials.gov/show/NCT01975376

Keywords

  1. 1/15/19 1/15/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 15, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Cardiovascular Disease NCT01975376

Eligibility Cardiovascular Disease NCT01975376

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be on background lipid lowering treatment.
Description

ID.1

Data type

boolean

must be at high risk of a cv event.
Description

ID.2

Data type

boolean

must have an ldl c >/=70 mg/dl (1.8 mmol/l) and < 100 mg/dl (2.6 mmol/l) or non-hdl-c >/= 100 mg/dl (2.6 mmol/l) and < 130 mg/dl (3.4 mmol/l).
Description

ID.3

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
an ldl c < 70 mg/dl (1.8 mmol/l) or >/= 100 mg/dl (2.6 mmol/l) or non hdl-c < 100 mg/dl (2.6 mmol/l) or >/=130 mg/dl (3.4 mmol/l).
Description

ID.4

Data type

boolean

planned coronary (pci or cabg) or other arterial revascularization.
Description

ID.5

Data type

boolean

new york heart association class iv congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.
Description

ID.6

Data type

boolean

chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by mdrd formula or with end state renal disease on dialysis.
Description

ID.7

Data type

boolean

history of hemorrhagic stroke.
Description

ID.8

Data type

boolean

prior exposure to bococizumab or other investigational pcsk9 inhibitor.
Description

ID.9

Data type

boolean

Similar models

Eligibility Cardiovascular Disease NCT01975376

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
must be on background lipid lowering treatment.
boolean
ID.2
Item
must be at high risk of a cv event.
boolean
ID.3
Item
must have an ldl c >/=70 mg/dl (1.8 mmol/l) and < 100 mg/dl (2.6 mmol/l) or non-hdl-c >/= 100 mg/dl (2.6 mmol/l) and < 130 mg/dl (3.4 mmol/l).
boolean
Item Group
C0680251 (UMLS CUI)
ID.4
Item
an ldl c < 70 mg/dl (1.8 mmol/l) or >/= 100 mg/dl (2.6 mmol/l) or non hdl-c < 100 mg/dl (2.6 mmol/l) or >/=130 mg/dl (3.4 mmol/l).
boolean
ID.5
Item
planned coronary (pci or cabg) or other arterial revascularization.
boolean
ID.6
Item
new york heart association class iv congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.
boolean
ID.7
Item
chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by mdrd formula or with end state renal disease on dialysis.
boolean
ID.8
Item
history of hemorrhagic stroke.
boolean
ID.9
Item
prior exposure to bococizumab or other investigational pcsk9 inhibitor.
boolean

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