ID

20420

Description

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. Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Keywords

Versions (1)
  1. 2/22/17 2/22/17 -
Uploaded on

February 22, 2017

DOI

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License

Creative Commons BY 4.0
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Permanent Termination Of Trial Medication PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

English

Permanent Termination Of Trial Medication PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 forms  
Permanent Trial Medication
Description

Permanent Trial Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0205355
1. Last intake of trial drug A, B and C (dd mon yy)
Description

Last Intake of Drug A, B and C

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1512806
2. Last intake of trial drug D (dd mon yy)
Description

Last Intake of Drug D

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1512806
3. Did the patient permanently stopped taking any of the trial medication prematurely
Description

Permanently stopped taking medication

Data type

boolean

Alias
UMLS CUI [1]
C0850893
arm of the trial medication
Description

arm of the trial medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0332307
4. If yes please check which arm of the trial medication (ABC, D or all ABCD) and the reasons why for each treatment arm discontinued. (indicate one reason):
Description

If Yes

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0457454
A. Outcome Event (must be recorded on outcome event page)
Description

Outcome events

Data type

integer

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1547647
UMLS CUI [1,3]
C0441471
B. Adverse Event (Specify Adverse Event below)
Description

Adverse Event

Data type

integer

Alias
UMLS CUI [1]
C0877248
Specify Adverse Event
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0877248
C. Non compliant with protocol (explain below)
Description

Non Compliant With Protocol

Data type

integer

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
D. Lost to follow-up (explain below)
Description

Lost to follow-up

Data type

integer

Alias
UMLS CUI [1]
C1522577
E. Consent withdrawn (not due to adverse event, explain below)
Description

Consent withdrawn

Data type

integer

Alias
UMLS CUI [1]
C1707492
F. Other (explain below)
Description

Other

Data type

integer

Alias
UMLS CUI [1]
C0205394
Explain
Description

Explain

Data type

text

Alias
UMLS CUI [1]
C1521902
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Similar models

Permanent Termination Of Trial Medication PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Permanent Trial Medication
C0013227 (UMLS CUI-1)
C0205355 (UMLS CUI-2)
Last Intake of Drug A, B and C
Item
1. Last intake of trial drug A, B and C (dd mon yy)
date
C0011008 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
Last Intake of Drug D
Item
2. Last intake of trial drug D (dd mon yy)
date
C0011008 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
Permanently stopped taking medication
Item
3. Did the patient permanently stopped taking any of the trial medication prematurely
boolean
C0850893 (UMLS CUI [1])
Item Group
arm of the trial medication
C0013227 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
If Yes
Item
4. If yes please check which arm of the trial medication (ABC, D or all ABCD) and the reasons why for each treatment arm discontinued. (indicate one reason):
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Item
A. Outcome Event (must be recorded on outcome event page)
integer
C0441471 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
Outcome events
Code List
A. Outcome Event (must be recorded on outcome event page)
CL Item
ABC (1)
CL Item
D (2)
CL Item
ABCD (3)
Item
B. Adverse Event (Specify Adverse Event below)
integer
C0877248 (UMLS CUI [1])
Outcome events
Code List
B. Adverse Event (Specify Adverse Event below)
CL Item
ABC (1)
CL Item
D (2)
CL Item
ABCD (3)
Adverse Event
Item
Specify Adverse Event
text
C2348235 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
C. Non compliant with protocol (explain below)
integer
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Outcome events
Code List
C. Non compliant with protocol (explain below)
CL Item
ABC (1)
CL Item
D (2)
CL Item
ABCD (3)
Item
D. Lost to follow-up (explain below)
integer
C1522577 (UMLS CUI [1])
Outcome events
Code List
D. Lost to follow-up (explain below)
CL Item
ABC (1)
CL Item
D (2)
CL Item
ABCD (3)
Item
E. Consent withdrawn (not due to adverse event, explain below)
integer
C1707492 (UMLS CUI [1])
Outcome events
Code List
E. Consent withdrawn (not due to adverse event, explain below)
CL Item
ABC (1)
CL Item
D (2)
CL Item
ABCD (3)
Item
F. Other (explain below)
integer
C0205394 (UMLS CUI [1])
Outcome events
Code List
F. Other (explain below)
CL Item
ABC (1)
CL Item
D (2)
CL Item
ABCD (3)
Explain
Item
Explain
text
C1521902 (UMLS CUI [1])
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