ID

28935

Beschrijving

Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3); ODM derived from: https://clinicaltrials.gov/show/NCT00642174

Link

https://clinicaltrials.gov/show/NCT00642174

Trefwoorden

Versies (1)
  1. 18-02-18 18-02-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 februari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00642174

Engels

Eligibility Diabetes Mellitus NCT00642174

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus and on oral or parenteral hypoglycemic therapy for at least 1 month.
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | ORAL HYPOGLYCEMIC TREATMENT | Hypoglycemic Agents Parenteral

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0747045
UMLS CUI [3,1]
C0020616
UMLS CUI [3,2]
C1518896
history of coronary artery disease with or without other types of vascular disease (such as peripheral vascular disease).
Beschrijving

Coronary Artery Disease | Vascular Diseases | Vascular Diseases Absent | Peripheral Vascular Diseases | Peripheral Vascular Diseases Absent

Datatype

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0042373
UMLS CUI [3,1]
C0042373
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0085096
UMLS CUI [5,1]
C0085096
UMLS CUI [5,2]
C0332197
taking aspirin 75-325 mg/day for at least 1 week prior to randomization.
Beschrijving

Aspirin U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0456683
between the ages of 18-74 years old.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
if a woman of child bearing age, must not be pregnant and must agree to use reliable method of birth control during the duration of the study.
Beschrijving

Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
thienopyridine therapy within 30 days or have a defined need for thienopyridine treatment.
Beschrijving

thienopyridine | Patient need for thienopyridine

Datatype

boolean

Alias
UMLS CUI [1]
C1120149
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1120149
coronary artery bypass graft (cabg) or percutaneous coronary intervention (pci) with no stent placed within 30 days.
Beschrijving

Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Placement of stent Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C1532338
UMLS CUI [3,1]
C0522776
UMLS CUI [3,2]
C0332197
planned coronary revascularization
Beschrijving

Coronary revascularisation Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1301732
hemoglobin a1c (hba1c) > or equal to 10 mg/dl within the last 3 months.
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
received fibrolytic therapy <24 hours prior to randomization.
Beschrijving

Fibrinolytic Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0040044
received non-fibrin-specific fibrinolytic therapy <48 hours prior to randomization.
Beschrijving

Fibrinolytic Therapy | Fibrin Specific Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0040044
UMLS CUI [2,1]
C0015982
UMLS CUI [2,2]
C0205369
UMLS CUI [2,3]
C0332197
at risk of bleeding.
Beschrijving

Bleeding Risk

Datatype

boolean

Alias
UMLS CUI [1]
C3251812
history of ischemic stroke, transient ischemic attack (tia), intercranial neoplasm, arteriovenous malformation, or aneurysm.
Beschrijving

Ischemic stroke | Transient Ischemic Attack | Neoplasms, Intracranial | Arteriovenous malformation | Aneurysm

Datatype

boolean

Alias
UMLS CUI [1]
C0948008
UMLS CUI [2]
C0007787
UMLS CUI [3]
C1527390
UMLS CUI [4]
C0003857
UMLS CUI [5]
C0002940
body weight <60 kilograms (kg).
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
international normalized ratio (inr) >1.5, platelet count <100,000/mm3, or anemia (hemoglobin <10 gm/dl) within 1 week of study entry.
Beschrijving

International Normalized Ratio | Platelet Count measurement | Anemia | Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0525032
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0002871
UMLS CUI [4]
C0518015
are receiving or will receive oral anticoagulation or antiplatelet treatment therapy.
Beschrijving

Anticoagulation Therapy Oral | Antiplatelet therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C1096021
are being treated with daily non-steroidal anti-inflammatory drugs (nsaids).
Beschrijving

Anti-Inflammatory Agents, Non-Steroidal

Datatype

boolean

Alias
UMLS CUI [1]
C0003211
are pregnant, breast-feeding or plan to become pregnant.
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Similar models

Eligibility Diabetes Mellitus NCT00642174

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | ORAL HYPOGLYCEMIC TREATMENT | Hypoglycemic Agents Parenteral
Item
type 2 diabetes mellitus and on oral or parenteral hypoglycemic therapy for at least 1 month.
boolean
C0011860 (UMLS CUI [1])
C0747045 (UMLS CUI [2])
C0020616 (UMLS CUI [3,1])
C1518896 (UMLS CUI [3,2])
Coronary Artery Disease | Vascular Diseases | Vascular Diseases Absent | Peripheral Vascular Diseases | Peripheral Vascular Diseases Absent
Item
history of coronary artery disease with or without other types of vascular disease (such as peripheral vascular disease).
boolean
C1956346 (UMLS CUI [1])
C0042373 (UMLS CUI [2])
C0042373 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0085096 (UMLS CUI [4])
C0085096 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Aspirin U/day
Item
taking aspirin 75-325 mg/day for at least 1 week prior to randomization.
boolean
C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Age
Item
between the ages of 18-74 years old.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods
Item
if a woman of child bearing age, must not be pregnant and must agree to use reliable method of birth control during the duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
thienopyridine | Patient need for thienopyridine
Item
thienopyridine therapy within 30 days or have a defined need for thienopyridine treatment.
boolean
C1120149 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C1120149 (UMLS CUI [2,2])
Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Placement of stent Absent
Item
coronary artery bypass graft (cabg) or percutaneous coronary intervention (pci) with no stent placed within 30 days.
boolean
C0010055 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0522776 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Coronary revascularisation Planned
Item
planned coronary revascularization
boolean
C0877341 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hemoglobin a1c (hba1c) > or equal to 10 mg/dl within the last 3 months.
boolean
C0202054 (UMLS CUI [1])
Fibrinolytic Therapy
Item
received fibrolytic therapy <24 hours prior to randomization.
boolean
C0040044 (UMLS CUI [1])
Fibrinolytic Therapy | Fibrin Specific Absent
Item
received non-fibrin-specific fibrinolytic therapy <48 hours prior to randomization.
boolean
C0040044 (UMLS CUI [1])
C0015982 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Bleeding Risk
Item
at risk of bleeding.
boolean
C3251812 (UMLS CUI [1])
Ischemic stroke | Transient Ischemic Attack | Neoplasms, Intracranial | Arteriovenous malformation | Aneurysm
Item
history of ischemic stroke, transient ischemic attack (tia), intercranial neoplasm, arteriovenous malformation, or aneurysm.
boolean
C0948008 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C1527390 (UMLS CUI [3])
C0003857 (UMLS CUI [4])
C0002940 (UMLS CUI [5])
Body Weight
Item
body weight <60 kilograms (kg).
boolean
C0005910 (UMLS CUI [1])
International Normalized Ratio | Platelet Count measurement | Anemia | Hemoglobin measurement
Item
international normalized ratio (inr) >1.5, platelet count <100,000/mm3, or anemia (hemoglobin <10 gm/dl) within 1 week of study entry.
boolean
C0525032 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0002871 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Anticoagulation Therapy Oral | Antiplatelet therapy
Item
are receiving or will receive oral anticoagulation or antiplatelet treatment therapy.
boolean
C0003281 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1096021 (UMLS CUI [2])
Anti-Inflammatory Agents, Non-Steroidal
Item
are being treated with daily non-steroidal anti-inflammatory drugs (nsaids).
boolean
C0003211 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
are pregnant, breast-feeding or plan to become pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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