ID

28605

Beschreibung

Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects; ODM derived from: https://clinicaltrials.gov/show/NCT00930670

Link

https://clinicaltrials.gov/show/NCT00930670

Stichworte

Versionen (1)
  1. 24.01.18 24.01.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24. Januar 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00930670

Englisch

Eligibility Coronary Artery Disease NCT00930670

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject must be 18 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
bare metal stent implantation
Beschreibung

Bare metal stent Implantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2825200
UMLS CUI [1,2]
C0021107
discharged with dual antiplatelet therapy for at least 60 days
Beschreibung

Patient Discharge Antiplatelet therapy Combined

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030685
UMLS CUI [1,2]
C1096021
UMLS CUI [1,3]
C0205195
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who do not consent to participate in the study
Beschreibung

Study Subject Participation Status Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0558080
premenopausal women not using contraceptive methods or without a negative pregnancy test in the past week
Beschreibung

Premenopausal state Contraceptive methods Lacking | Premenopausal state Pregnancy test negative Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0427780
UMLS CUI [2,3]
C0332268
patients treated or planned to be treated with oral anticoagulants
Beschreibung

Oral anticoagulants | Oral anticoagulants Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0354604
UMLS CUI [2,1]
C0354604
UMLS CUI [2,2]
C1301732
present treatment with or clear indication for treatment with a ppi or h2 antagonists
Beschreibung

PPI therapy | H2 receptor antagonist therapy | Indication PPI therapy | Indication H2 receptor antagonist therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1541225
UMLS CUI [2]
C0338238
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C1541225
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0338238
allergy or intolerance to study medications including ranitidine, proton pump inhibitors, atorvastatin, rosuvastatin, aspirin and/or clopidogrel
Beschreibung

Hypersensitivity Investigational New Drugs | Intolerance to Investigational New Drugs | Ranitidine allergy | Proton pump inhibitor allergy | Atorvastatin allergy | Hypersensitivity Rosuvastatin | Aspirin allergy | Hypersensitivity Clopidogrel | Intolerance to Ranitidine | Intolerance to Proton Pump Inhibitors | Intolerance to Atorvastatin | Intolerance to Rosuvastatin | Intolerance to Aspirin | Intolerance to Clopidogrel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
UMLS CUI [3]
C0570577
UMLS CUI [4]
C0570578
UMLS CUI [5]
C4274308
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0965129
UMLS CUI [7]
C0004058
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0070166
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C0034665
UMLS CUI [10,1]
C1744706
UMLS CUI [10,2]
C0358591
UMLS CUI [11,1]
C1744706
UMLS CUI [11,2]
C0286651
UMLS CUI [12,1]
C1744706
UMLS CUI [12,2]
C0965129
UMLS CUI [13,1]
C1744706
UMLS CUI [13,2]
C0004057
UMLS CUI [14,1]
C1744706
UMLS CUI [14,2]
C0070166
patient treated with a strong cyp2c19 interacting drug
Beschreibung

Pharmaceutical Preparation Interaction CYP2C19

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1704675
UMLS CUI [1,3]
C3714749
history of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment
Beschreibung

Abnormal bleeding

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
history of intracranial hemorrhage or intracranial surgery in the last 3 months
Beschreibung

Intracranial Hemorrhages | Intracranial surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0151699
UMLS CUI [2]
C0745377
history of gastro-intestinal ulcers in the last 3 months
Beschreibung

Gastrointestinal ulcer

Datentyp

boolean

Alias
UMLS CUI [1]
C0237938
any serious illness or any condition that the investigator feels would influence the impact of this therapy on the subject
Beschreibung

Illness Serious Influence Therapeutic procedure | Condition Influence Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C4054723
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0087111
known platelet count < 100000/mm3 at time of enrollment or within 24 hours prior to enrollment
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00930670

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject must be 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Bare metal stent Implantation
Item
bare metal stent implantation
boolean
C2825200 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
Patient Discharge Antiplatelet therapy Combined
Item
discharged with dual antiplatelet therapy for at least 60 days
boolean
C0030685 (UMLS CUI [1,1])
C1096021 (UMLS CUI [1,2])
C0205195 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status Unwilling
Item
patients who do not consent to participate in the study
boolean
C2348568 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Premenopausal state Contraceptive methods Lacking | Premenopausal state Pregnancy test negative Lacking
Item
premenopausal women not using contraceptive methods or without a negative pregnancy test in the past week
boolean
C0232969 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0232969 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Oral anticoagulants | Oral anticoagulants Planned
Item
patients treated or planned to be treated with oral anticoagulants
boolean
C0354604 (UMLS CUI [1])
C0354604 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
PPI therapy | H2 receptor antagonist therapy | Indication PPI therapy | Indication H2 receptor antagonist therapy
Item
present treatment with or clear indication for treatment with a ppi or h2 antagonists
boolean
C1541225 (UMLS CUI [1])
C0338238 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C1541225 (UMLS CUI [3,2])
C3146298 (UMLS CUI [4,1])
C0338238 (UMLS CUI [4,2])
Hypersensitivity Investigational New Drugs | Intolerance to Investigational New Drugs | Ranitidine allergy | Proton pump inhibitor allergy | Atorvastatin allergy | Hypersensitivity Rosuvastatin | Aspirin allergy | Hypersensitivity Clopidogrel | Intolerance to Ranitidine | Intolerance to Proton Pump Inhibitors | Intolerance to Atorvastatin | Intolerance to Rosuvastatin | Intolerance to Aspirin | Intolerance to Clopidogrel
Item
allergy or intolerance to study medications including ranitidine, proton pump inhibitors, atorvastatin, rosuvastatin, aspirin and/or clopidogrel
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0570577 (UMLS CUI [3])
C0570578 (UMLS CUI [4])
C4274308 (UMLS CUI [5])
C0020517 (UMLS CUI [6,1])
C0965129 (UMLS CUI [6,2])
C0004058 (UMLS CUI [7])
C0020517 (UMLS CUI [8,1])
C0070166 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C0034665 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C0358591 (UMLS CUI [10,2])
C1744706 (UMLS CUI [11,1])
C0286651 (UMLS CUI [11,2])
C1744706 (UMLS CUI [12,1])
C0965129 (UMLS CUI [12,2])
C1744706 (UMLS CUI [13,1])
C0004057 (UMLS CUI [13,2])
C1744706 (UMLS CUI [14,1])
C0070166 (UMLS CUI [14,2])
Pharmaceutical Preparation Interaction CYP2C19
Item
patient treated with a strong cyp2c19 interacting drug
boolean
C0013227 (UMLS CUI [1,1])
C1704675 (UMLS CUI [1,2])
C3714749 (UMLS CUI [1,3])
Abnormal bleeding
Item
history of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment
boolean
C1458140 (UMLS CUI [1])
Intracranial Hemorrhages | Intracranial surgery
Item
history of intracranial hemorrhage or intracranial surgery in the last 3 months
boolean
C0151699 (UMLS CUI [1])
C0745377 (UMLS CUI [2])
Gastrointestinal ulcer
Item
history of gastro-intestinal ulcers in the last 3 months
boolean
C0237938 (UMLS CUI [1])
Illness Serious Influence Therapeutic procedure | Condition Influence Therapeutic procedure
Item
any serious illness or any condition that the investigator feels would influence the impact of this therapy on the subject
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Platelet Count measurement
Item
known platelet count < 100000/mm3 at time of enrollment or within 24 hours prior to enrollment
boolean
C0032181 (UMLS CUI [1])
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