ID

35609

Beschreibung

Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Monotherapy (HOST-EXAM); ODM derived from: https://clinicaltrials.gov/show/NCT02044250

Link

https://clinicaltrials.gov/show/NCT02044250

Stichworte

Versionen (1)
  1. 12.03.19 12.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

12. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT02044250

Englisch

Eligibility Coronary Heart Disease NCT02044250

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject must be at least 20 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. subject who received dual or triple antiplatelet therapy for 1 year (± 6 months) after drug-eluting stent implantation for coronary artery disease
Beschreibung

Antiplatelet therapy Dual | Antiplatelet therapy Triple | Drug-eluting stent placement Coronary Artery Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1096021
UMLS CUI [1,2]
C0205173
UMLS CUI [2,1]
C1096021
UMLS CUI [2,2]
C0205174
UMLS CUI [3,1]
C4286029
UMLS CUI [3,2]
C1956346
3. subject without clinical events during 1 year (± 6 months)
Beschreibung

Event Clinical Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0332197
4. subject who is confirmed to receive antiplatelet monotherapy (aspirin or clopidogrel)
Beschreibung

Antiplatelet therapy | Aspirin | clopidogrel

Datentyp

boolean

Alias
UMLS CUI [1]
C1096021
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0070166
5. subject is able to verbally confirm understandings of risks, benefits and treatment and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Beschreibung

Comprehension Study Protocol | Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030701
6. subject is fertile woman and able to verbally confirm using effective methods of contraception
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the patient has a known hypersensitivity or contraindication to aspirin or clopidogrel.
Beschreibung

Aspirin allergy | Medical contraindication Aspirin | Hypersensitivity Clopidogrel | Medical contraindication Clopidogrel

Datentyp

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0004057
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0070166
2. subject who cannot interrupt to receive antiplatelet drug.
Beschreibung

Antiplatelet Agents Discontinue Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085826
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
3. history of bleeding diathesis or known coagulopathy requiring interruption of antiplatelet drugs.
Beschreibung

Bleeding tendency | Blood Coagulation Disorders | Requirement Discontinuation Antiplatelet Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0085826
4. an elective intervention or surgical procedure is planned that would necessitate long-term interruption of antiplatelet drugs during the study.
Beschreibung

Intervention elective Planned | Elective Surgical Procedure Planned | Requirement Discontinuation Long-term Antiplatelet Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0439608
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0206058
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0443252
UMLS CUI [3,4]
C0085826
5. liver function abnormality or renal failure
Beschreibung

Liver Dysfunction | Kidney Failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0035078
ast, alt > 3 x unl
Beschreibung

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
creatinine > 2.0 mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
6. non-cardiac co-morbid conditions are present with life expectancy < 2 years.
Beschreibung

Comorbidity | Exception Heart Diseases | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0023671
7. subject who is pregnant, breastfeeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. subject who is not suitable to enroll the study decided by investigator
Beschreibung

Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Ähnliche Modelle

Eligibility Coronary Heart Disease NCT02044250

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subject must be at least 20 years of age.
boolean
C0001779 (UMLS CUI [1])
Antiplatelet therapy Dual | Antiplatelet therapy Triple | Drug-eluting stent placement Coronary Artery Disease
Item
2. subject who received dual or triple antiplatelet therapy for 1 year (± 6 months) after drug-eluting stent implantation for coronary artery disease
boolean
C1096021 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C1096021 (UMLS CUI [2,1])
C0205174 (UMLS CUI [2,2])
C4286029 (UMLS CUI [3,1])
C1956346 (UMLS CUI [3,2])
Event Clinical Absent
Item
3. subject without clinical events during 1 year (± 6 months)
boolean
C0441471 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Antiplatelet therapy | Aspirin | clopidogrel
Item
4. subject who is confirmed to receive antiplatelet monotherapy (aspirin or clopidogrel)
boolean
C1096021 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C0070166 (UMLS CUI [3])
Comprehension Study Protocol | Informed Consent | Informed Consent Patient Representative
Item
5. subject is able to verbally confirm understandings of risks, benefits and treatment and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C0030701 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods
Item
6. subject is fertile woman and able to verbally confirm using effective methods of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Aspirin allergy | Medical contraindication Aspirin | Hypersensitivity Clopidogrel | Medical contraindication Clopidogrel
Item
1. the patient has a known hypersensitivity or contraindication to aspirin or clopidogrel.
boolean
C0004058 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0070166 (UMLS CUI [4,2])
Antiplatelet Agents Discontinue Unable
Item
2. subject who cannot interrupt to receive antiplatelet drug.
boolean
C0085826 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Bleeding tendency | Blood Coagulation Disorders | Requirement Discontinuation Antiplatelet Agents
Item
3. history of bleeding diathesis or known coagulopathy requiring interruption of antiplatelet drugs.
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0085826 (UMLS CUI [3,3])
Intervention elective Planned | Elective Surgical Procedure Planned | Requirement Discontinuation Long-term Antiplatelet Agents
Item
4. an elective intervention or surgical procedure is planned that would necessitate long-term interruption of antiplatelet drugs during the study.
boolean
C0184661 (UMLS CUI [1,1])
C0439608 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0206058 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
C0085826 (UMLS CUI [3,4])
Liver Dysfunction | Kidney Failure
Item
5. liver function abnormality or renal failure
boolean
C0086565 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast, alt > 3 x unl
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Creatinine measurement, serum
Item
creatinine > 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Comorbidity | Exception Heart Diseases | Life Expectancy
Item
6. non-cardiac co-morbid conditions are present with life expectancy < 2 years.
boolean
C0009488 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
7. subject who is pregnant, breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status Inappropriate
Item
8. subject who is not suitable to enroll the study decided by investigator
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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