ID

16121

Description

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

Keywords

Versions (1)
  1. 6/30/16 6/30/16 -
Uploaded on

June 30, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetic Patients NCT02164578

English

Eligibility Type 2 Diabetic Patients NCT02164578

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes duration between 2 and 20 years
Description

Diabetes Mellitus, Non-Insulin-Dependent disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
documented atherosclerotic cvd:
Description

Atherosclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0004153
major cardiovascular event in medical history or
Description

Cardiovascular event Major

Data type

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
coronary angiography showing a coronary artery stenosis of > 50 % or
Description

Coronary angiography Coronary Stenosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0085532
UMLS CUI [1,2]
C0242231
carotid ultrasound showing an imt > 1 mm and plaque of carotid artery or
Description

Carotid artery ultrasound Carotid Intima-Media Thickness | Carotid artery ultrasound Carotid Artery Plaque

Data type

boolean

Alias
UMLS CUI [1,1]
C0948945
UMLS CUI [1,2]
C1960466
UMLS CUI [2,1]
C0948945
UMLS CUI [2,2]
C0751633
left ventricular hypertrophy or
Description

left ventricular hypertrophy

Data type

boolean

Alias
UMLS CUI [1]
C0149721
macroalbuminuria in the absence of other renal diseases
Description

Macroalbuminuria | Kidney Diseases Absent

Data type

boolean

Alias
UMLS CUI [1]
C1654921
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0332197
increased hscrp (> 2 mg/l but < 10 mg/l) and/or increased pai 1 (> 15 ng/ml)
Description

High-sensitivity C-reactive protein increased | Plasminogen Activator Inhibitor 1 Increased

Data type

boolean

Alias
UMLS CUI [1]
C1963867
UMLS CUI [2,1]
C0030190
UMLS CUI [2,2]
C0205217
stable treatment with statins (if tolerated)
Description

Statins Therapeutic procedure Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205360
age 40 - 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

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
Description

Cardiovascular event needing oral anticoagulants | Cardiovascular event needing Therapeutic procedure Platelet Inhibitors Double | Acute Coronary Syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0686904
UMLS CUI [1,3]
C0354604
UMLS CUI [2,1]
C1320716
UMLS CUI [2,2]
C0686904
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0032188
UMLS CUI [2,5]
C0205173
UMLS CUI [3]
C0948089
sustained uncontrolled hypertension: systolic bp > 180 mmhg or diastolic bp > 100 mmhg
Description

Uncontrolled hypertension Sustained | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0443318
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
hypersensitivity to the active substance
Description

Hypersensitivity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
active clinically significant bleeding
Description

BLEEDING ACTIVE Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0741554
UMLS CUI [1,2]
C2826293
significant risks for major bleeding
Description

Hemorrhage Major Risk Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C0750502
concomitant treatment of acs with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (tia)
Description

Antiplatelet therapy Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1,1]
C1096021
UMLS CUI [1,2]
C0948089
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
hepatic disease associated with coagulopathy and clinically relevant bleeding risk
Description

Liver diseases Associated with Blood Coagulation Disorder Bleeding Risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0005779
UMLS CUI [1,4]
C3251812
chronic renal failure with egfr < 15 ml/min (mdrd formula)
Description

Chronic Kidney Failure renal function GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1,1]
C0022661
UMLS CUI [1,2]
C2170215
pregnant or breast-feeding woman and woman without adequate method of contraception.
Description

Pregnancy | Breast Feeding | Gender | Contraceptive methods Not used

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0079399
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0445107
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Similar models

Eligibility Type 2 Diabetic Patients NCT02164578

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent disease length
Item
type 2 diabetes duration between 2 and 20 years
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Atherosclerosis
Item
documented atherosclerotic cvd:
boolean
C0004153 (UMLS CUI [1])
Cardiovascular event Major
Item
major cardiovascular event in medical history or
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Coronary angiography Coronary Stenosis
Item
coronary angiography showing a coronary artery stenosis of > 50 % or
boolean
C0085532 (UMLS CUI [1,1])
C0242231 (UMLS CUI [1,2])
Carotid artery ultrasound Carotid Intima-Media Thickness | Carotid artery ultrasound Carotid Artery Plaque
Item
carotid ultrasound showing an imt > 1 mm and plaque of carotid artery or
boolean
C0948945 (UMLS CUI [1,1])
C1960466 (UMLS CUI [1,2])
C0948945 (UMLS CUI [2,1])
C0751633 (UMLS CUI [2,2])
left ventricular hypertrophy
Item
left ventricular hypertrophy or
boolean
C0149721 (UMLS CUI [1])
Macroalbuminuria | Kidney Diseases Absent
Item
macroalbuminuria in the absence of other renal diseases
boolean
C1654921 (UMLS CUI [1])
C0022658 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
High-sensitivity C-reactive protein increased | Plasminogen Activator Inhibitor 1 Increased
Item
increased hscrp (> 2 mg/l but < 10 mg/l) and/or increased pai 1 (> 15 ng/ml)
boolean
C1963867 (UMLS CUI [1])
C0030190 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
Statins Therapeutic procedure Stable
Item
stable treatment with statins (if tolerated)
boolean
C0360714 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Age
Item
age 40 - 75 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiovascular event needing oral anticoagulants | Cardiovascular event needing Therapeutic procedure Platelet Inhibitors Double | Acute Coronary Syndrome
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 [1,1])
C0686904 (UMLS CUI [1,2])
C0354604 (UMLS CUI [1,3])
C1320716 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0032188 (UMLS CUI [2,4])
C0205173 (UMLS CUI [2,5])
C0948089 (UMLS CUI [3])
Uncontrolled hypertension Sustained | Systolic Pressure | Diastolic blood pressure
Item
sustained uncontrolled hypertension: systolic bp > 180 mmhg or diastolic bp > 100 mmhg
boolean
C1868885 (UMLS CUI [1,1])
C0443318 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs
Item
hypersensitivity to the active substance
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
BLEEDING ACTIVE Clinical Significance
Item
active clinically significant bleeding
boolean
C0741554 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hemorrhage Major Risk Significant
Item
significant risks for major bleeding
boolean
C0019080 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0750502 (UMLS CUI [1,4])
Antiplatelet therapy Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack
Item
concomitant treatment of acs with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (tia)
boolean
C1096021 (UMLS CUI [1,1])
C0948089 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Liver diseases Associated with Blood Coagulation Disorder Bleeding Risk
Item
hepatic disease associated with coagulopathy and clinically relevant bleeding risk
boolean
C0023895 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0005779 (UMLS CUI [1,3])
C3251812 (UMLS CUI [1,4])
Chronic Kidney Failure renal function GFR estimation by MDRD
Item
chronic renal failure with egfr < 15 ml/min (mdrd formula)
boolean
C0022661 (UMLS CUI [1,1])
C2170215 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Gender | Contraceptive methods Not used
Item
pregnant or breast-feeding woman and woman without adequate method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0445107 (UMLS CUI [4,2])
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