ID

19924

Beschrijving

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one. Visit 1 (Month 0)

Trefwoorden

Versies (2)
  1. 31-01-17 31-01-17 -
  2. 16-02-17 16-02-17 -
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31 januari 2017

DOI

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Creative Commons BY-NC 3.0
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Screening Baseline PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Engels

Screening Baseleine PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulieren  
Informed Consent
Beschrijving

Informed Consent

Alias
UMLS CUI-1
C0021430
Date of visit 1 (dd-mon-yy)
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0545082
2. Patient has given informed consent prior to enrollment
Beschrijving

Informed consent prior to enrollment

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
3. Date of informed consent (dd-mon-yy)
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Demographics
Beschrijving

Demographics

Alias
UMLS CUI-1
C1704791
4. Date of birth (dd-mon-yyyy)
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
5. Sex
Beschrijving

Sex

Datatype

integer

Alias
UMLS CUI [1]
C0079399
6. Ethnicity (mark only one):
Beschrijving

Ethnicity

Datatype

integer

Alias
UMLS CUI [1]
C0015031
Presenting Symptoms
Beschrijving

Presenting Symptoms

Alias
UMLS CUI-1
C1457887
7. Date of onset qualifying stroke symptoms (dd-mon-yy)
Beschrijving

Date of onset qualifying stroke symptoms

Datatype

date

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C3275427
8. Time of onset of qualifying stroke symptoms (24 hour clock time-hh:mm)
Beschrijving

Time of onset of qualifying stroke symptoms

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C3275427
Please indicate symptoms at time of qualifying stroke
Beschrijving

Indication of symptoms

Datatype

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0332162
UMLS CUI [1,4]
C3275427
9. Stupor or coma
Beschrijving

Stupor or coma

Datatype

integer

Alias
UMLS CUI [1]
C0085628
UMLS CUI [2]
C0009421
10. Loss of consciousness
Beschrijving

Loss of consciousness

Datatype

integer

Alias
UMLS CUI [1]
C0041657
11. Headache
Beschrijving

Headache

Datatype

integer

Alias
UMLS CUI [1]
C0018681
12. Nausea-Vomiting
Beschrijving

Nausea-Vomiting

Datatype

integer

Alias
UMLS CUI [1]
C0027498
13. Dysphasia
Beschrijving

Dysphasia

Datatype

integer

Alias
UMLS CUI [1]
C0973461
14. Dysarthria
Beschrijving

Dysarthria

Datatype

integer

Alias
UMLS CUI [1]
C0013362
15. Hemaniopia
Beschrijving

Hemaniopia

Datatype

integer

Alias
UMLS CUI [1]
C0018979
16. Ataxia
Beschrijving

Ataxia

Datatype

integer

Alias
UMLS CUI [1]
C0004134
17. Diplopia
Beschrijving

Diplopia

Datatype

integer

Alias
UMLS CUI [1]
C0012569
18. Amaurosis fugax
Beschrijving

Amaurosis fugax

Datatype

integer

Alias
UMLS CUI [1]
C0149793
If Present
Beschrijving

Presence of Amaurosis fugax

Datatype

integer

Alias
UMLS CUI [1,1]
C0149793
UMLS CUI [1,2]
C0150312
19. Vertigo
Beschrijving

Vertigo

Datatype

integer

Alias
UMLS CUI [1]
C0042571
20. Location of qualifying stroke
Beschrijving

Location of qualifying stroke

Datatype

integer

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C3275427
21. Please indicate which of the following tests were done in conjunction with the qualifying stroke:
Beschrijving

Indicate which of the following tests were done in conjunction

Datatype

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C3275427
If `Other`, please specify:
Beschrijving

If ´Other`, please specify

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0205394
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Similar models

Screening Baseleine PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Date
Item
Date of visit 1 (dd-mon-yy)
date
C0011008 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Informed consent prior to enrollment
Item
2. Patient has given informed consent prior to enrollment
boolean
C0021430 (UMLS CUI [1])
Date
Item
3. Date of informed consent (dd-mon-yy)
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Date of birth
Item
4. Date of birth (dd-mon-yyyy)
date
C0421451 (UMLS CUI [1])
Item
5. Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
5. Sex
CL Item
male (1)
CL Item
female (2)
Item
6. Ethnicity (mark only one):
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
6. Ethnicity (mark only one):
CL Item
South Asian (1)
CL Item
Chinese (2)
CL Item
Japanese (3)
CL Item
Malays (4)
CL Item
Other Asian (5)
CL Item
Arab, Persian (6)
CL Item
Black African (Includes African American) (7)
CL Item
Colored African (8)
CL Item
European/ Caucasian (9)
CL Item
Native Latin (10)
CL Item
Caribbean Hispanic (11)
CL Item
Other (12)
Item Group
Presenting Symptoms
C1457887 (UMLS CUI-1)
Date of onset qualifying stroke symptoms
Item
7. Date of onset qualifying stroke symptoms (dd-mon-yy)
date
C0332162 (UMLS CUI [1,1])
C3275427 (UMLS CUI [1,2])
Time of onset of qualifying stroke symptoms
Item
8. Time of onset of qualifying stroke symptoms (24 hour clock time-hh:mm)
time
C0040223 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C3275427 (UMLS CUI [1,3])
Indication of symptoms
Item
Please indicate symptoms at time of qualifying stroke
text
C3146298 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C3275427 (UMLS CUI [1,4])
Item
9. Stupor or coma
integer
C0085628 (UMLS CUI [1])
C0009421 (UMLS CUI [2])
Stupor or coma
Code List
9. Stupor or coma
CL Item
Present (1)
CL Item
Absent  (2)
CL Item
Unknown (3)
Item
10. Loss of consciousness
integer
C0041657 (UMLS CUI [1])
Stupor or coma
Code List
10. Loss of consciousness
CL Item
Present (1)
CL Item
Absent  (2)
CL Item
Unknown (3)
Item
11. Headache
integer
C0018681 (UMLS CUI [1])
Stupor or coma
Code List
11. Headache
CL Item
Present (1)
CL Item
Absent  (2)
CL Item
Unknown (3)
Item
12. Nausea-Vomiting
integer
C0027498 (UMLS CUI [1])
Stupor or coma
Code List
12. Nausea-Vomiting
CL Item
Present (1)
CL Item
Absent  (2)
CL Item
Unknown (3)
Item
13. Dysphasia
integer
C0973461 (UMLS CUI [1])
Stupor or coma
Code List
13. Dysphasia
CL Item
Present (1)
CL Item
Absent  (2)
CL Item
Unknown (3)
Item
14. Dysarthria
integer
C0013362 (UMLS CUI [1])
Stupor or coma
Code List
14. Dysarthria
CL Item
Present (1)
CL Item
Absent  (2)
CL Item
Unknown (3)
Item
15. Hemaniopia
integer
C0018979 (UMLS CUI [1])
Stupor or coma
Code List
15. Hemaniopia
CL Item
Present (1)
CL Item
Absent  (2)
CL Item
Unknown (3)
Item
16. Ataxia
integer
C0004134 (UMLS CUI [1])
Stupor or coma
Code List
16. Ataxia
CL Item
Present (1)
CL Item
Absent  (2)
CL Item
Unknown (3)
Item
17. Diplopia
integer
C0012569 (UMLS CUI [1])
Stupor or coma
Code List
17. Diplopia
CL Item
Present (1)
CL Item
Absent  (2)
CL Item
Unknown (3)
Item
18. Amaurosis fugax
integer
C0149793 (UMLS CUI [1])
Stupor or coma
Code List
18. Amaurosis fugax
CL Item
Present (1)
CL Item
Absent  (2)
CL Item
Unknown (3)
Item
If Present
integer
C0149793 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Presence of Amaurosis fugax
Code List
If Present
CL Item
Left (1)
CL Item
Right (2)
Item
19. Vertigo
integer
C0042571 (UMLS CUI [1])
Stupor or coma
Code List
19. Vertigo
CL Item
Present (1)
CL Item
Absent  (2)
CL Item
Unknown (3)
Item
20. Location of qualifying stroke
integer
C0450429 (UMLS CUI [1,1])
C3275427 (UMLS CUI [1,2])
Location of qualifying stroke
Code List
20. Location of qualifying stroke
CL Item
Left (1)
CL Item
Right (2)
CL Item
Brainstem (3)
CL Item
Uncertain (4)
Item
21. Please indicate which of the following tests were done in conjunction with the qualifying stroke:
integer
C3146298 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C3275427 (UMLS CUI [1,3])
Indicate which of the following tests were done in conjunction
Code List
21. Please indicate which of the following tests were done in conjunction with the qualifying stroke:
CL Item
Diffusion weighted imaging (0)
CL Item
Computerized Tomography (1)
CL Item
Magnetic resonance imaging (2)
CL Item
Perfusion imaging (3)
CL Item
Conventional Angiography (4)
CL Item
Doppler/ Duplex (5)
CL Item
Other (6)
If ´Other`, please specify
Item
If `Other`, please specify:
text
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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