ID

35562

Descrição

Impact of Renal Function on Ticagrelor-Induced Antiplatelet Effects in Coronary Artery Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02323971

Link

https://clinicaltrials.gov/show/NCT02323971

Palavras-chave

Versões (1)
  1. 09/03/2019 09/03/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

9 de março de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02323971

Inglês

Eligibility Coronary Artery Disease NCT02323971

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients presenting with moderate-high risk non-steacs defined according the current guidelines
Descrição

Moderate to high risk of Non ST segment elevation acute coronary syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1998133
UMLS CUI [1,2]
C3160886
patients received a loading dose or under chronic treatment with aspirin (100 mg per day) as per standard of care
Descrição

Loading dose Aspirin | ASPIRIN USE CHRONIC U/day Standard of Care

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3714444
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0741254
UMLS CUI [2,2]
C0456683
UMLS CUI [2,3]
C2936643
age between 18 and 80 years old
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
bmi between 18 and 35 kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
provide written informed consent prior to any study specific procedures
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of hemorrhagic stroke or intracranial bleeding
Descrição

Brain hemorrhage | Intracranial Hemorrhages

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0553692
UMLS CUI [2]
C0151699
known allergies to aspirin, ticagrelor, or clopidogrel
Descrição

Aspirin allergy | Hypersensitivity Ticagrelor | Hypersensitivity Clopidogrel

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1999375
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
on treatment with oral anticoagulation (coumarin derivate, dabigatran, rivaroxaban, apixaban)
Descrição

Anticoagulation Therapy Oral | Coumarin Derivative | dabigatran | rivaroxaban | apixaban

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0010206
UMLS CUI [2,2]
C1527240
UMLS CUI [3]
C2348066
UMLS CUI [4]
C1739768
UMLS CUI [5]
C1831808
hemoglobin <10 gm/dl
Descrição

Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
platelet count <80x106/ml
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
blood dyscrasias, active bleeding or hemodynamic instability.
Descrição

Hematological Disease | Hemorrhage | Hemodynamic instability

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0019080
UMLS CUI [3]
C0948268
patients on hemodialysis or peritoneal dialysis, a change in estimated glomerular filtration rate (egfr) greater than 15 ml/min within 90 days prior to enrollment, or estimated glomerular filtration rate (egfr) lower than 15 ml/min/1.73m2
Descrição

Hemodialysis | Peritoneal Dialysis | Estimated Glomerular Filtration Rate Change | Estimated Glomerular Filtration Rate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2]
C0031139
UMLS CUI [3,1]
C3811844
UMLS CUI [3,2]
C0392747
UMLS CUI [4]
C3811844
patients with known infectious diseases or neoplasia
Descrição

Communicable Diseases | Neoplasia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0027651
baseline alt >2.5 times the upper limit of normal
Descrição

Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151905
patients with sick sinus syndrome (sss) or high degree av block without pacemaker protection
Descrição

Sick Sinus Syndrome | AV BLOCK HIGH DEGREE | Artificial cardiac pacemaker Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0037052
UMLS CUI [2]
C0741311
UMLS CUI [3,1]
C0030163
UMLS CUI [3,2]
C0332197
drugs interfering with 2c19 metabolism (to avoid interaction with clopidogrel): fluconazole (diflucan), ketoconazole (nizoral), voriconazole (vfend), etravirine (intelence), felbamate (felbatol), fluoxetine (prozac, serafem, symbyax), fluvoxamine (luvox), and ticlopidine (ticlid). since omeprazole is the most used proton-pump inhibitor in our clinical environment, we will keep the same prescription rate in both groups to avoid differences results from this described interaction
Descrição

Pharmaceutical Preparations Interfere with CYP2C19 Metabolism | Fluconazole | Diflucan | Ketoconazole | Nizoral | voriconazole | Vfend | etravirine | Intelence | felbamate | Felbatol | Fluoxetine | Prozac | Symbyax | Fluvoxamine | Luvox | Ticlopidine | Ticlid

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C3714749
UMLS CUI [1,4]
C0025519
UMLS CUI [2]
C0016277
UMLS CUI [3]
C0699601
UMLS CUI [4]
C0022625
UMLS CUI [5]
C0699439
UMLS CUI [6]
C0393080
UMLS CUI [7]
C1136812
UMLS CUI [8]
C1456409
UMLS CUI [9]
C2241753
UMLS CUI [10]
C0060135
UMLS CUI [11]
C0728742
UMLS CUI [12]
C0016365
UMLS CUI [13]
C0162373
UMLS CUI [14]
C1330549
UMLS CUI [15]
C0085228
UMLS CUI [16]
C0086307
UMLS CUI [17]
C0040207
UMLS CUI [18]
C0733418
drugs interfering cyp3a4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin
Descrição

Pharmaceutical Preparations Interfere with CYP3A4 Metabolism | Ketoconazole | Itraconazole | voriconazole | Clarithromycin | nefazodone | Ritonavir | Saquinavir | Nelfinavir | Indinavir | Atazanavir | telithromycin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C3714798
UMLS CUI [1,4]
C0025519
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0064113
UMLS CUI [4]
C0393080
UMLS CUI [5]
C0055856
UMLS CUI [6]
C0068485
UMLS CUI [7]
C0292818
UMLS CUI [8]
C0286738
UMLS CUI [9]
C0525005
UMLS CUI [10]
C0376637
UMLS CUI [11]
C1145759
UMLS CUI [12]
C0907410
pregnant females
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Coronary Artery Disease NCT02323971

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Moderate to high risk of Non ST segment elevation acute coronary syndrome
Item
patients presenting with moderate-high risk non-steacs defined according the current guidelines
boolean
C1998133 (UMLS CUI [1,1])
C3160886 (UMLS CUI [1,2])
Loading dose Aspirin | ASPIRIN USE CHRONIC U/day Standard of Care
Item
patients received a loading dose or under chronic treatment with aspirin (100 mg per day) as per standard of care
boolean
C3714444 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0741254 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
Age
Item
age between 18 and 80 years old
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi between 18 and 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
provide written informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Brain hemorrhage | Intracranial Hemorrhages
Item
history of hemorrhagic stroke or intracranial bleeding
boolean
C0553692 (UMLS CUI [1])
C0151699 (UMLS CUI [2])
Aspirin allergy | Hypersensitivity Ticagrelor | Hypersensitivity Clopidogrel
Item
known allergies to aspirin, ticagrelor, or clopidogrel
boolean
C0004058 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1999375 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
Anticoagulation Therapy Oral | Coumarin Derivative | dabigatran | rivaroxaban | apixaban
Item
on treatment with oral anticoagulation (coumarin derivate, dabigatran, rivaroxaban, apixaban)
boolean
C0003281 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0010206 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
C2348066 (UMLS CUI [3])
C1739768 (UMLS CUI [4])
C1831808 (UMLS CUI [5])
Hemoglobin measurement
Item
hemoglobin <10 gm/dl
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count <80x106/ml
boolean
C0032181 (UMLS CUI [1])
Hematological Disease | Hemorrhage | Hemodynamic instability
Item
blood dyscrasias, active bleeding or hemodynamic instability.
boolean
C0018939 (UMLS CUI [1])
C0019080 (UMLS CUI [2])
C0948268 (UMLS CUI [3])
Hemodialysis | Peritoneal Dialysis | Estimated Glomerular Filtration Rate Change | Estimated Glomerular Filtration Rate
Item
patients on hemodialysis or peritoneal dialysis, a change in estimated glomerular filtration rate (egfr) greater than 15 ml/min within 90 days prior to enrollment, or estimated glomerular filtration rate (egfr) lower than 15 ml/min/1.73m2
boolean
C0019004 (UMLS CUI [1])
C0031139 (UMLS CUI [2])
C3811844 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C3811844 (UMLS CUI [4])
Communicable Diseases | Neoplasia
Item
patients with known infectious diseases or neoplasia
boolean
C0009450 (UMLS CUI [1])
C0027651 (UMLS CUI [2])
Alanine aminotransferase increased
Item
baseline alt >2.5 times the upper limit of normal
boolean
C0151905 (UMLS CUI [1])
Sick Sinus Syndrome | AV BLOCK HIGH DEGREE | Artificial cardiac pacemaker Absent
Item
patients with sick sinus syndrome (sss) or high degree av block without pacemaker protection
boolean
C0037052 (UMLS CUI [1])
C0741311 (UMLS CUI [2])
C0030163 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Pharmaceutical Preparations Interfere with CYP2C19 Metabolism | Fluconazole | Diflucan | Ketoconazole | Nizoral | voriconazole | Vfend | etravirine | Intelence | felbamate | Felbatol | Fluoxetine | Prozac | Symbyax | Fluvoxamine | Luvox | Ticlopidine | Ticlid
Item
drugs interfering with 2c19 metabolism (to avoid interaction with clopidogrel): fluconazole (diflucan), ketoconazole (nizoral), voriconazole (vfend), etravirine (intelence), felbamate (felbatol), fluoxetine (prozac, serafem, symbyax), fluvoxamine (luvox), and ticlopidine (ticlid). since omeprazole is the most used proton-pump inhibitor in our clinical environment, we will keep the same prescription rate in both groups to avoid differences results from this described interaction
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3714749 (UMLS CUI [1,3])
C0025519 (UMLS CUI [1,4])
C0016277 (UMLS CUI [2])
C0699601 (UMLS CUI [3])
C0022625 (UMLS CUI [4])
C0699439 (UMLS CUI [5])
C0393080 (UMLS CUI [6])
C1136812 (UMLS CUI [7])
C1456409 (UMLS CUI [8])
C2241753 (UMLS CUI [9])
C0060135 (UMLS CUI [10])
C0728742 (UMLS CUI [11])
C0016365 (UMLS CUI [12])
C0162373 (UMLS CUI [13])
C1330549 (UMLS CUI [14])
C0085228 (UMLS CUI [15])
C0086307 (UMLS CUI [16])
C0040207 (UMLS CUI [17])
C0733418 (UMLS CUI [18])
Pharmaceutical Preparations Interfere with CYP3A4 Metabolism | Ketoconazole | Itraconazole | voriconazole | Clarithromycin | nefazodone | Ritonavir | Saquinavir | Nelfinavir | Indinavir | Atazanavir | telithromycin
Item
drugs interfering cyp3a4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3714798 (UMLS CUI [1,3])
C0025519 (UMLS CUI [1,4])
C0022625 (UMLS CUI [2])
C0064113 (UMLS CUI [3])
C0393080 (UMLS CUI [4])
C0055856 (UMLS CUI [5])
C0068485 (UMLS CUI [6])
C0292818 (UMLS CUI [7])
C0286738 (UMLS CUI [8])
C0525005 (UMLS CUI [9])
C0376637 (UMLS CUI [10])
C1145759 (UMLS CUI [11])
C0907410 (UMLS CUI [12])
Pregnancy
Item
pregnant females
boolean
C0032961 (UMLS CUI [1])
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