ID

22844

Beschreibung

PLASMA 2 Trial: Examination of Once Daily (QD) Dosing of A-002 In Subjects With Stable Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00525954

Link

https://clinicaltrials.gov/show/NCT00525954

Stichworte

Versionen (1)
  1. 13.06.17 13.06.17 -
Hochgeladen am

13. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00525954

Englisch

Eligibility Coronary Artery Disease NCT00525954

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects are eligible for inclusion if they meet the following inclusion criteria:
Beschreibung

ID.1

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
1. men and women ≥18 years of age
Beschreibung

ID.2

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. written informed consent from the subject
Beschreibung

ID.3

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
3. stable cad
Beschreibung

ID.4

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010068
UMLS CUI [1,2]
C0205360
4. stable medical condition, will be compliant and able to comply with the requirements of the protocol
Beschreibung

ID.5

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C1321605
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects must not meet any of the following exclusion criteria:
Beschreibung

ID.6

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
1. planned coronary artery bypass surgery (cabg)
Beschreibung

ID.7

Datentyp

boolean

Alias
UMLS CUI [1]
C0010055
2. acute or chronic heart failure as defined by the new york heart association (nyha) classification as functional class iii or class iv
Beschreibung

ID.8

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0264714
3. hospitalization for acute coronary syndrome (acs) if troponin >0.1 ng/ml in the preceding 6 weeks
Beschreibung

ID.9

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948089
UMLS CUI [1,2]
C1141948
4. hospitalization for st-segment elevation acute myocardial infarction (stemi) in the preceding 12 weeks
Beschreibung

ID.10

Datentyp

boolean

Alias
UMLS CUI [1]
C1536220
5. subjects with chronic inflammatory disease (e.g., rheumatoid arthritis), inflammatory bowel disease, recent (12 weeks) systemic or localized infection (the latter requiring clinical intervention), or major surgery
Beschreibung

ID.11

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1290886
UMLS CUI [1,2]
C0679637
6. hs-crp ≥15 mg/l repeated on at least 2 occasions >24 hours apart due to non-cardiovascular systemic inflammatory conditions (e.g., rheumatoid disease)
Beschreibung

ID.12

Datentyp

boolean

Alias
UMLS CUI [1]
C1833181
7. subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to screening or prior experience with a-002.
Beschreibung

ID.13

Datentyp

boolean

Alias
UMLS CUI [1]
C0681814
8. subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma or carcinoma in situ of the cervix, with measures other than a minor, complete surgical excision (e.g., chemotherapy), or radiation therapy
Beschreibung

ID.14

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
9. subjects who have received immunosuppressant therapy within 30 days prior to entry
Beschreibung

ID.15

Datentyp

boolean

Alias
UMLS CUI [1]
C1096650
10. subjects who have received anti-tumor necrosis factor (for example, infliximab) therapy within 6 months prior to entry
Beschreibung

ID.16

Datentyp

boolean

Alias
UMLS CUI [1]
C0281481
11. the presence of severe liver disease with cirrhosis, recent active hepatitis, active chronic hepatitis, alt or ast >3 x upper limit of normal, biliary obstruction with hyperbilirubinemia (total bilirubin >2 x upper limit of normal)
Beschreibung

ID.17

Datentyp

boolean

Alias
UMLS CUI [1]
C3829821
12. active cholecystitis, gall bladder symptoms, or potential hepato-biliary abnormalities
Beschreibung

ID.18

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016977
UMLS CUI [1,2]
C0008325
13. the presence of moderate or severe renal impairment (crcl <60 ml/min or creatinine >1.5 x upper limit of normal), nephrotic syndrome, or subjects undergoing dialysis
Beschreibung

ID.19

Datentyp

boolean

Alias
UMLS CUI [1]
C3829820
14. uncontrolled diabetes mellitus (known hba1c >11% within the last 1 month prior to screening)
Beschreibung

ID.20

Datentyp

boolean

Alias
UMLS CUI [1]
C2733146
15. females who are nursing, pregnant, or intend to become pregnant during the time of the study, or subjects who have a positive serum pregnancy test at visit 1 (if the subject is a female of child-bearing potential). women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. a reliable method for this study is defined as one of the following: oral or injectable contraceptives, intrauterine device (iud), contraceptive implants, tubal ligation, hysterectomy, a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom).
Beschreibung

ID.21

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0700589
16. subjects who have a history of alcohol or drug abuse within 1 year of study entry
Beschreibung

ID.22

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085762
17. subject living too far from participating center or unable to return for follow-up visits
Beschreibung

ID.23

Datentyp

boolean

Alias
UMLS CUI [1]
C3258451
18. subjects who in the opinion of the investigator are a poor medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete understanding of the study which may affect their ability to take drugs as prescribed or comply with instructions
Beschreibung

ID.24

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0419566
UMLS CUI [1,2]
C0815144
19. known human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) infection
Beschreibung

ID.25

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0220847
20. treatment with any systemic corticosteroid within the 30-day period prior to study entry or the use of inhaled steroids within the 14-day period prior to study entry
Beschreibung

ID.26

Datentyp

boolean

Alias
UMLS CUI [1]
C4053960
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00525954

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
subjects are eligible for inclusion if they meet the following inclusion criteria:
boolean
C1512693 (UMLS CUI [1])
ID.2
Item
1. men and women ≥18 years of age
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
2. written informed consent from the subject
boolean
C0021430 (UMLS CUI [1])
ID.4
Item
3. stable cad
boolean
C0010068 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
ID.5
Item
4. stable medical condition, will be compliant and able to comply with the requirements of the protocol
boolean
C0205360 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
subjects must not meet any of the following exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
ID.7
Item
1. planned coronary artery bypass surgery (cabg)
boolean
C0010055 (UMLS CUI [1])
ID.8
Item
2. acute or chronic heart failure as defined by the new york heart association (nyha) classification as functional class iii or class iv
boolean
C0018802 (UMLS CUI [1,1])
C0264714 (UMLS CUI [1,2])
ID.9
Item
3. hospitalization for acute coronary syndrome (acs) if troponin >0.1 ng/ml in the preceding 6 weeks
boolean
C0948089 (UMLS CUI [1,1])
C1141948 (UMLS CUI [1,2])
ID.10
Item
4. hospitalization for st-segment elevation acute myocardial infarction (stemi) in the preceding 12 weeks
boolean
C1536220 (UMLS CUI [1])
ID.11
Item
5. subjects with chronic inflammatory disease (e.g., rheumatoid arthritis), inflammatory bowel disease, recent (12 weeks) systemic or localized infection (the latter requiring clinical intervention), or major surgery
boolean
C1290886 (UMLS CUI [1,1])
C0679637 (UMLS CUI [1,2])
ID.12
Item
6. hs-crp ≥15 mg/l repeated on at least 2 occasions >24 hours apart due to non-cardiovascular systemic inflammatory conditions (e.g., rheumatoid disease)
boolean
C1833181 (UMLS CUI [1])
ID.13
Item
7. subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to screening or prior experience with a-002.
boolean
C0681814 (UMLS CUI [1])
ID.14
Item
8. subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma or carcinoma in situ of the cervix, with measures other than a minor, complete surgical excision (e.g., chemotherapy), or radiation therapy
boolean
C0006826 (UMLS CUI [1])
ID.15
Item
9. subjects who have received immunosuppressant therapy within 30 days prior to entry
boolean
C1096650 (UMLS CUI [1])
ID.16
Item
10. subjects who have received anti-tumor necrosis factor (for example, infliximab) therapy within 6 months prior to entry
boolean
C0281481 (UMLS CUI [1])
ID.17
Item
11. the presence of severe liver disease with cirrhosis, recent active hepatitis, active chronic hepatitis, alt or ast >3 x upper limit of normal, biliary obstruction with hyperbilirubinemia (total bilirubin >2 x upper limit of normal)
boolean
C3829821 (UMLS CUI [1])
ID.18
Item
12. active cholecystitis, gall bladder symptoms, or potential hepato-biliary abnormalities
boolean
C0016977 (UMLS CUI [1,1])
C0008325 (UMLS CUI [1,2])
ID.19
Item
13. the presence of moderate or severe renal impairment (crcl <60 ml/min or creatinine >1.5 x upper limit of normal), nephrotic syndrome, or subjects undergoing dialysis
boolean
C3829820 (UMLS CUI [1])
ID.20
Item
14. uncontrolled diabetes mellitus (known hba1c >11% within the last 1 month prior to screening)
boolean
C2733146 (UMLS CUI [1])
ID.21
Item
15. females who are nursing, pregnant, or intend to become pregnant during the time of the study, or subjects who have a positive serum pregnancy test at visit 1 (if the subject is a female of child-bearing potential). women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. a reliable method for this study is defined as one of the following: oral or injectable contraceptives, intrauterine device (iud), contraceptive implants, tubal ligation, hysterectomy, a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom).
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
ID.22
Item
16. subjects who have a history of alcohol or drug abuse within 1 year of study entry
boolean
C0085762 (UMLS CUI [1,1])
ID.23
Item
17. subject living too far from participating center or unable to return for follow-up visits
boolean
C3258451 (UMLS CUI [1])
ID.24
Item
18. subjects who in the opinion of the investigator are a poor medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete understanding of the study which may affect their ability to take drugs as prescribed or comply with instructions
boolean
C0419566 (UMLS CUI [1,1])
C0815144 (UMLS CUI [1,2])
ID.25
Item
19. known human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) infection
boolean
C0019682 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
ID.26
Item
20. treatment with any systemic corticosteroid within the 30-day period prior to study entry or the use of inhaled steroids within the 14-day period prior to study entry
boolean
C4053960 (UMLS CUI [1])
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