ID

28783

Description

Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine; ODM derived from: https://clinicaltrials.gov/show/NCT00950339

Link

https://clinicaltrials.gov/show/NCT00950339

Keywords

Versions (1)
  1. 2/4/18 2/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT00950339

English

Eligibility Coronary Heart Disease NCT00950339

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject is at least 18 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. subject is willing to comply with pre-specified follow-up evaluation and can be contacted by telephone.
Description

Compliance behavior Follow-up Evaluation | Telephone Contact

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C1261322
UMLS CUI [2,1]
C0039457
UMLS CUI [2,2]
C3812666
3. use of clopidogrel (>=75mg) and aspirin(>=75mg) for at least 1 month.
Description

Clopidogrel Dose | Aspirin Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0070166
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C0178602
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known allergy to ppi of h2 blockers
Description

Proton pump inhibitor allergy | H2 receptor antagonist allergy

Data type

boolean

Alias
UMLS CUI [1]
C0570578
UMLS CUI [2]
C0570573
2. known thrombocytopenia or thrombocytopathia
Description

Thrombocytopenia | Thrombocytopathy

Data type

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0005818
3. subject is currently enrolled in another investigational study of a new drug, biologic or device at the time of study screening. note: subjects who are participating in the long term follow-up phase of a previously investigational and now fda-approved product are not excluded by this criterion.
Description

Study Subject Participation Status | Investigational New Drugs | Biological agents Investigational | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0005515
UMLS CUI [3,2]
C1517586
UMLS CUI [4]
C2346570
4. subject with symptomatic heart failure of lvef ≤ 25%
Description

Heart failure Symptomatic | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0428772
5. acute myocardial infarction within the past 30 days.
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
6. no acute inflammatory event during the past month (e.g. infection, autoimmune or acute coronary event)
Description

Event inflammatory | Communicable Disease | Autoimmune Disease | Event Coronary

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0333348
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0004364
UMLS CUI [4,1]
C0441471
UMLS CUI [4,2]
C1522318
7. concurrent medical condition with a life expectancy of less than 12 months.
Description

Comorbidity | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0023671
8. known severe renal failure (serum creatinine level >2.5 mg/dl).
Description

Kidney Failure Severe | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
9. history of bleeding diathesis or coagulopathy or inability or unwillingness to receive blood transfusions.
Description

Bleeding tendency | Blood Coagulation Disorders | Blood Transfusion Receive Unable | Blood Transfusion Receive Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3,1]
C0005841
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0005841
UMLS CUI [4,2]
C1514756
UMLS CUI [4,3]
C0558080
10. evidence of active gastrointestinal bleeding or a history of such bleeding that is not known to have been treated and proven to have resolved.
Description

Gastrointestinal Hemorrhage | Hemorrhage untreated | Hemorrhage Resolution Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0019080
UMLS CUI [3,2]
C1514893
UMLS CUI [3,3]
C0332268
11. history of hepatitis (viral, ischemic or chemically-induced); clinical jaundice, history of cirrhosis.
Description

Hepatitis | Viral hepatitis | Ischemic hepatitis | Hepatitis chemically induced | Icterus | Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0042721
UMLS CUI [3]
C0473117
UMLS CUI [4,1]
C0019158
UMLS CUI [4,2]
C0007994
UMLS CUI [5]
C0022346
UMLS CUI [6]
C0023890
12. patient treated with anticoagulant medication (coumadin, lmwh)
Description

Anticoagulant therapy | Coumadin | Heparin, Low-Molecular-Weight

Data type

boolean

Alias
UMLS CUI [1]
C0150457
UMLS CUI [2]
C0699129
UMLS CUI [3]
C0019139
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Similar models

Eligibility Coronary Heart Disease NCT00950339

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subject is at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
Compliance behavior Follow-up Evaluation | Telephone Contact
Item
2. subject is willing to comply with pre-specified follow-up evaluation and can be contacted by telephone.
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0039457 (UMLS CUI [2,1])
C3812666 (UMLS CUI [2,2])
Clopidogrel Dose | Aspirin Dose
Item
3. use of clopidogrel (>=75mg) and aspirin(>=75mg) for at least 1 month.
boolean
C0070166 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0004057 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Proton pump inhibitor allergy | H2 receptor antagonist allergy
Item
1. known allergy to ppi of h2 blockers
boolean
C0570578 (UMLS CUI [1])
C0570573 (UMLS CUI [2])
Thrombocytopenia | Thrombocytopathy
Item
2. known thrombocytopenia or thrombocytopathia
boolean
C0040034 (UMLS CUI [1])
C0005818 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Biological agents Investigational | Investigational Medical Device
Item
3. subject is currently enrolled in another investigational study of a new drug, biologic or device at the time of study screening. note: subjects who are participating in the long term follow-up phase of a previously investigational and now fda-approved product are not excluded by this criterion.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0005515 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C2346570 (UMLS CUI [4])
Heart failure Symptomatic | Left ventricular ejection fraction
Item
4. subject with symptomatic heart failure of lvef ≤ 25%
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
Myocardial Infarction
Item
5. acute myocardial infarction within the past 30 days.
boolean
C0027051 (UMLS CUI [1])
Event inflammatory | Communicable Disease | Autoimmune Disease | Event Coronary
Item
6. no acute inflammatory event during the past month (e.g. infection, autoimmune or acute coronary event)
boolean
C0441471 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
C0441471 (UMLS CUI [4,1])
C1522318 (UMLS CUI [4,2])
Comorbidity | Life Expectancy
Item
7. concurrent medical condition with a life expectancy of less than 12 months.
boolean
C0009488 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Kidney Failure Severe | Creatinine measurement, serum
Item
8. known severe renal failure (serum creatinine level >2.5 mg/dl).
boolean
C0035078 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Bleeding tendency | Blood Coagulation Disorders | Blood Transfusion Receive Unable | Blood Transfusion Receive Unwilling
Item
9. history of bleeding diathesis or coagulopathy or inability or unwillingness to receive blood transfusions.
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0005841 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0005841 (UMLS CUI [4,1])
C1514756 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Gastrointestinal Hemorrhage | Hemorrhage untreated | Hemorrhage Resolution Lacking
Item
10. evidence of active gastrointestinal bleeding or a history of such bleeding that is not known to have been treated and proven to have resolved.
boolean
C0017181 (UMLS CUI [1])
C0019080 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0019080 (UMLS CUI [3,1])
C1514893 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Hepatitis | Viral hepatitis | Ischemic hepatitis | Hepatitis chemically induced | Icterus | Liver Cirrhosis
Item
11. history of hepatitis (viral, ischemic or chemically-induced); clinical jaundice, history of cirrhosis.
boolean
C0019158 (UMLS CUI [1])
C0042721 (UMLS CUI [2])
C0473117 (UMLS CUI [3])
C0019158 (UMLS CUI [4,1])
C0007994 (UMLS CUI [4,2])
C0022346 (UMLS CUI [5])
C0023890 (UMLS CUI [6])
Anticoagulant therapy | Coumadin | Heparin, Low-Molecular-Weight
Item
12. patient treated with anticoagulant medication (coumadin, lmwh)
boolean
C0150457 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
C0019139 (UMLS CUI [3])
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