ID

20230

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.

Keywords

Versions (2)
  1. 2/15/17 2/15/17 -
  2. 2/20/17 2/20/17 -
Uploaded on

February 15, 2017

DOI

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License

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

English

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

1 forms  
Inclusion / Exclusion Criteria
Description

Inclusion / Exclusion Criteria

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

Entry criteria

Data type

boolean

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

Numbers of the corresponding criteria

Data type

text

Randomisation
Description

Randomisation

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

Date of randomisation

Data type

date

Trial Drug Administration
Description

Trial Drug Administration

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

Trial medication kit

Data type

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:
Description

If yes

Data type

text

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

If NO

Data type

integer

Explain other:
Description

Other

Data type

text

Preparation For Next Visit
Description

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.
Description

Investigator´s Declaration

Data type

text

Signature by investigator
Description

Signature

Data type

text

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

Investigator Signature Date

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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