ID

20334

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

Link

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

Trefwoorden

Versies (2)
  1. 15-02-17 15-02-17 -
  2. 20-02-17 20-02-17 -
Geüploaded op

20 februari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Inclusion Exclusion Randomization Trial Drug Administration PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Engels

Inclusion Exclusion Randomization Trial Drug Administration PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulieren  
Inclusion Exclusion Criteria
Beschrijving

Inclusion Exclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-3
C0680251
Did the subject meet all the entry criteria at the time of enrollment (see opposite page)
Beschrijving

Entry criteria

Datatype

boolean

Alias
UMLS CUI [1]
C1516637
If no, please give line number(s) of the corresponding criteria not met
Beschrijving

Numbers of the corresponding criteria

Datatype

text

Randomisation
Beschrijving

Randomisation

Alias
UMLS CUI-1
C0034656
Date of randomisation using IVRS (dd mon yy)
Beschrijving

Date of randomisation

Datatype

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Trial Drug Administration
Beschrijving

Trial Drug Administration

Alias
UMLS CUI-1
C3469597
Will the trial medication kit be dispensed to the patient?
Beschrijving

Trial medication kit

Datatype

boolean

Alias
UMLS CUI [1]
C0013227
If YES, provide patient with trial medication kit assigned by IVRS. Stick the label from trial medication kit below. If label is lost, please enter assigned medication number below:
Beschrijving

If yes

Datatype

text

Alias
UMLS CUI [1]
C2360065
UMLS CUI [2]
C1521902
If NO, primary reason for not dispensing trial drug (indicate one)
Beschrijving

If NO

Datatype

integer

Alias
UMLS CUI [1]
C1521902
Explain other:
Beschrijving

Other

Datatype

text

Alias
UMLS CUI [1]
C1521902
Preparation For Next Visit
Beschrijving

Preparation For Next Visit

Alias
UMLS CUI-1
C1521827
UMLS CUI-2
C1522577
Investigator´s Declaration By signing and dating this page, I declare that I have reviewed for accuracy all the case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed on the specified dates.
Beschrijving

Investigator´s Declaration

Datatype

text

Signature by investigator
Beschrijving

Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date (dd mon yy)
Beschrijving

Investigator Signature Date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Inclusion Exclusion Randomization Trial Drug Administration PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Exclusion Criteria
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-3)
Entry criteria
Item
Did the subject meet all the entry criteria at the time of enrollment (see opposite page)
boolean
C1516637 (UMLS CUI [1])
Numbers of the corresponding criteria
Item
If no, please give line number(s) of the corresponding criteria not met
text
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Date of randomisation
Item
Date of randomisation using IVRS (dd mon yy)
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Trial Drug Administration
C3469597 (UMLS CUI-1)
Trial medication kit
Item
Will the trial medication kit be dispensed to the patient?
boolean
C0013227 (UMLS CUI [1])
If yes
Item
If YES, provide patient with trial medication kit assigned by IVRS. Stick the label from trial medication kit below. If label is lost, please enter assigned medication number below:
text
C2360065 (UMLS CUI [1])
C1521902 (UMLS CUI [2])
Item
If NO, primary reason for not dispensing trial drug (indicate one)
integer
C1521902 (UMLS CUI [1])
If NO
Code List
If NO, primary reason for not dispensing trial drug (indicate one)
CL Item
Adverse event (1)
CL Item
Inclusion / Exclusion criteria not met (2)
CL Item
Lost follow-up (3)
CL Item
Consent withdrawn (not due to adverse event) (4)
CL Item
Other (explain below) (5)
Other
Item
Explain other:
text
C1521902 (UMLS CUI [1])
Item Group
Preparation For Next Visit
C1521827 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Investigator´s Declaration
Item
Investigator´s Declaration By signing and dating this page, I declare that I have reviewed for accuracy all the case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed on the specified dates.
text
Signature
Item
Signature by investigator
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Date (dd mon yy)
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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