ID

20230

Descripción

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.

Palabras clave

Versiones (2)
  1. 15/2/17 15/2/17 -
  2. 20/2/17 20/2/17 -
Subido en

15 de febrero de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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TEST Inclusion Exclusion Randomization Trial Drug Administration PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Inglés

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

1 formularios  
Inclusion / Exclusion Criteria
Descripción

Inclusion / Exclusion Criteria

1. Did the subject meet all the entry criteria at the time of enrollment (see opposite page)
Descripción

Entry criteria

Tipo de datos

boolean

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

Numbers of the corresponding criteria

Tipo de datos

text

Randomisation
Descripción

Randomisation

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

Date of randomisation

Tipo de datos

date

Trial Drug Administration
Descripción

Trial Drug Administration

4. Will the trial medication kit be dispensed to the patient
Descripción

Trial medication kit

Tipo de datos

boolean

5. 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:
Descripción

If yes

Tipo de datos

text

6. If NO, primary reason for not dispensing trial drug (indicate one)
Descripción

If NO

Tipo de datos

integer

Explain other:
Descripción

Other

Tipo de datos

text

Preparation For Next Visit
Descripción

Preparation For Next Visit

7. 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.
Descripción

Investigator´s Declaration

Tipo de datos

text

Signature by investigator
Descripción

Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
Date (dd mon yy)
Descripción

Investigator Signature Date

Tipo de datos

date

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

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion / Exclusion Criteria
Entry criteria
Item
1. 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
2. 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
3. Date of randomisation using IVRS (dd mon yy)
date
Item Group
Trial Drug Administration
Trial medication kit
Item
4. Will the trial medication kit be dispensed to the patient
boolean
If yes
Item
5. 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
Item
6. If NO, primary reason for not dispensing trial drug (indicate one)
integer
If NO
Code List
6. 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
Item Group
Preparation For Next Visit
Investigator´s Declaration
Item
7. 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
C1519316 (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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