ID

33329

Description

Colchicine in Atrial Fibrillation to Prevent Stroke; ODM derived from: https://clinicaltrials.gov/show/NCT02282098

Link

https://clinicaltrials.gov/show/NCT02282098

Keywords

Versions (1)
  1. 12/5/18 12/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02282098

English

Eligibility Atrial Fibrillation NCT02282098

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with atrial fibrillation who has been receiving chronic anticoagulation for at least 3 months.
Description

Atrial Fibrillation | Anticoagulation Therapy chronic

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0003281
UMLS CUI [2,2]
C0205191
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to colchicine such as allergy/hypersensitivity,
Description

Medical contraindication Colchicine | Colchicine allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0009262
UMLS CUI [2]
C0571131
receiving colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, anti-neoplastic, interleukin 1-1b antagonist, tumor necrosis factor-alpha inhibitor),
Description

Colchicine | Anti-Inflammatory Agents | Adrenal Cortex Hormones | Methotrexate | Antineoplastic Agents | Interleukin-1 Receptor Antagonist | Tumor necrosis factor-alpha inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0009262
UMLS CUI [2]
C0003209
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0025677
UMLS CUI [5]
C0003392
UMLS CUI [6]
C3536785
UMLS CUI [7]
C1562242
receiving food or co-medications such as strong-moderate cytochrome p450 3a4 inhibitors that will result in elevated plasma level of colchicine,
Description

CYP3A4 Inhibitor Strong | CYP3A4 Inhibitor Moderate | Etiology Plasma Colchicine Elevated

Data type

boolean

Alias
UMLS CUI [1,1]
C3830624
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3830624
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0032105
UMLS CUI [3,3]
C0009262
UMLS CUI [3,4]
C3163633
inflammatory disorders (sle, rheumatoid arthritis, connective tissue disorder) or chronic infection,
Description

Inflammatory disorder | Lupus Erythematosus, Systemic | Rheumatoid Arthritis | Connective Tissue Diseases | Chronic infectious disease

Data type

boolean

Alias
UMLS CUI [1]
C1290884
UMLS CUI [2]
C0024141
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0009782
UMLS CUI [5]
C0151317
severe renal (egfr< 30ml/min/1.73m2), or liver failure or liver aminotransferase (alt/ast > 2x upper limit of normal),
Description

Kidney Failure Severe | Estimated Glomerular Filtration Rate | Liver Failure Severe | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
UMLS CUI [3,1]
C0085605
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0151904
moderate or severe cytopenias (platelet < 100, neutrophil count < 1.5) or existing blood dyscrasia (e.g., myelodysplasia)
Description

Moderate cytopenia | Severe cytopenia | Platelet Count measurement | Neutrophil count | Hematological Disease | Myelodysplasia

Data type

boolean

Alias
UMLS CUI [1]
C1263978
UMLS CUI [2]
C1263979
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0200633
UMLS CUI [5]
C0018939
UMLS CUI [6]
C0026985
pregnant or lactating woman or woman of child bearing age no protected by reliable contraception.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
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Similar models

Eligibility Atrial Fibrillation NCT02282098

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation | Anticoagulation Therapy chronic
Item
patients with atrial fibrillation who has been receiving chronic anticoagulation for at least 3 months.
boolean
C0004238 (UMLS CUI [1])
C0003281 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Colchicine | Colchicine allergy
Item
contraindications to colchicine such as allergy/hypersensitivity,
boolean
C1301624 (UMLS CUI [1,1])
C0009262 (UMLS CUI [1,2])
C0571131 (UMLS CUI [2])
Colchicine | Anti-Inflammatory Agents | Adrenal Cortex Hormones | Methotrexate | Antineoplastic Agents | Interleukin-1 Receptor Antagonist | Tumor necrosis factor-alpha inhibitor
Item
receiving colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, anti-neoplastic, interleukin 1-1b antagonist, tumor necrosis factor-alpha inhibitor),
boolean
C0009262 (UMLS CUI [1])
C0003209 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
C0025677 (UMLS CUI [4])
C0003392 (UMLS CUI [5])
C3536785 (UMLS CUI [6])
C1562242 (UMLS CUI [7])
CYP3A4 Inhibitor Strong | CYP3A4 Inhibitor Moderate | Etiology Plasma Colchicine Elevated
Item
receiving food or co-medications such as strong-moderate cytochrome p450 3a4 inhibitors that will result in elevated plasma level of colchicine,
boolean
C3830624 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3830624 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0032105 (UMLS CUI [3,2])
C0009262 (UMLS CUI [3,3])
C3163633 (UMLS CUI [3,4])
Inflammatory disorder | Lupus Erythematosus, Systemic | Rheumatoid Arthritis | Connective Tissue Diseases | Chronic infectious disease
Item
inflammatory disorders (sle, rheumatoid arthritis, connective tissue disorder) or chronic infection,
boolean
C1290884 (UMLS CUI [1])
C0024141 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0009782 (UMLS CUI [4])
C0151317 (UMLS CUI [5])
Kidney Failure Severe | Estimated Glomerular Filtration Rate | Liver Failure Severe | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
severe renal (egfr< 30ml/min/1.73m2), or liver failure or liver aminotransferase (alt/ast > 2x upper limit of normal),
boolean
C0035078 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
C0085605 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0151905 (UMLS CUI [4])
C0151904 (UMLS CUI [5])
Moderate cytopenia | Severe cytopenia | Platelet Count measurement | Neutrophil count | Hematological Disease | Myelodysplasia
Item
moderate or severe cytopenias (platelet < 100, neutrophil count < 1.5) or existing blood dyscrasia (e.g., myelodysplasia)
boolean
C1263978 (UMLS CUI [1])
C1263979 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0200633 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0026985 (UMLS CUI [6])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
pregnant or lactating woman or woman of child bearing age no protected by reliable contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
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