ID

13534

Descrição

Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Cardiovascular Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02164578

Link

https://clinicaltrials.gov/show/NCT02164578

Palavras-chave

  1. 14/02/2016 14/02/2016 -
Transferido a

14 de fevereiro de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Type 2 Diabetic Patients NCT02164578

Eligibility Type 2 Diabetic Patients NCT02164578

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
Type 2 diabetes duration between 2 and 20 years
Descrição

Type 2 diabetes

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
Documented atherosclerotic cvd:
Descrição

Cvd

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
Major cardiovascular event in medical history
Descrição

Cardiovascular event

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1320716
Coronary angiography showing a coronary artery stenosis of > 50 % or
Descrição

Coronary Stenosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242231
Carotid ultrasound showing an imt > 1 mm and plaque of carotid artery
Descrição

Carotid Artery Plaque

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751633
Left ventricular hypertrophy
Descrição

Left ventricular hypertrophy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149721
Macroalbuminuria in the absence of other renal diseases
Descrição

Macroalbuminuria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1654921
Increased hscrp (> 2 mg/l but < 10 mg/l) and/or increased pai 1 (> 15 ng/ml)
Descrição

High-sensitivity C-reactive protein increased (hscrp)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1963867
Stable treatment with statins (if tolerated)
Descrição

Statin therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1314135
Age 40 - 75 years
Descrição

Age 40 - 75 years

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
CV event with need for oral anticoagulation or dual platelet inhibitor therapy or acute coronary syndrome < 12 month before study entry
Descrição

Cardiovascular event

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1320716
Sustained uncontrolled hypertension: systolic bp > 180 mmhg or diastolic bp > 100 mmhg
Descrição

Uncontrolled hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
Hypersensitivity to the active substance
Descrição

Hypersensitivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020517
Active clinically significant bleeding
Descrição

Bleeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0741554
Significant risks for major bleeding
Descrição

Bleeding Risk

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3251812
Concomitant treatment of acs with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (tia)
Descrição

Antiplatelet therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1096021
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
Descrição

Hepatic disease

Tipo de dados

boolean

Chronic renal failure with egfr < 15 ml/min (mdrd formula)
Descrição

Chronic renal failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022661
Pregnant or breast-feeding woman and woman without adequate method of contraception.
Descrição

Pregnant or breast-feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147

Similar models

Eligibility Type 2 Diabetic Patients NCT02164578

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Type 2 diabetes
Item
Type 2 diabetes duration between 2 and 20 years
boolean
C0011860 (UMLS CUI [1])
Cvd
Item
Documented atherosclerotic cvd:
boolean
C0007222 (UMLS CUI [1])
Cardiovascular event
Item
Major cardiovascular event in medical history
boolean
C1320716 (UMLS CUI [1])
Coronary Stenosis
Item
Coronary angiography showing a coronary artery stenosis of > 50 % or
boolean
C0242231 (UMLS CUI [1])
Carotid Artery Plaque
Item
Carotid ultrasound showing an imt > 1 mm and plaque of carotid artery
boolean
C0751633 (UMLS CUI [1])
Left ventricular hypertrophy
Item
Left ventricular hypertrophy
boolean
C0149721 (UMLS CUI [1])
Macroalbuminuria
Item
Macroalbuminuria in the absence of other renal diseases
boolean
C1654921 (UMLS CUI [1])
High-sensitivity C-reactive protein increased (hscrp)
Item
Increased hscrp (> 2 mg/l but < 10 mg/l) and/or increased pai 1 (> 15 ng/ml)
boolean
C1963867 (UMLS CUI [1])
Statin therapy
Item
Stable treatment with statins (if tolerated)
boolean
C1314135 (UMLS CUI [1])
Age 40 - 75 years
Item
Age 40 - 75 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiovascular event
Item
CV event with need for oral anticoagulation or dual platelet inhibitor therapy or acute coronary syndrome < 12 month before study entry
boolean
C1320716 (UMLS CUI [1])
Uncontrolled hypertension
Item
Sustained uncontrolled hypertension: systolic bp > 180 mmhg or diastolic bp > 100 mmhg
boolean
C1868885 (UMLS CUI [1])
Hypersensitivity
Item
Hypersensitivity to the active substance
boolean
C0020517 (UMLS CUI [1])
Bleeding
Item
Active clinically significant bleeding
boolean
C0741554 (UMLS CUI [1])
Bleeding Risk
Item
Significant risks for major bleeding
boolean
C3251812 (UMLS CUI [1])
Antiplatelet therapy
Item
Concomitant treatment of acs with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (tia)
boolean
C1096021 (UMLS CUI [1])
Hepatic disease
Item
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
boolean
Chronic renal failure
Item
Chronic renal failure with egfr < 15 ml/min (mdrd formula)
boolean
C0022661 (UMLS CUI [1])
Pregnant or breast-feeding
Item
Pregnant or breast-feeding woman and woman without adequate method of contraception.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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