ID

20336

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 20, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Visit 1A Events PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

English

Visit 1A Events PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 forms  
Events
Description

Events

Alias
UMLS CUI-1
C0877248
1. Has the patient experienced any of the following since randomization:
Description

Patient experience

Data type

text

Alias
UMLS CUI [1,1]
C0596545
UMLS CUI [1,2]
C0030705
Dizziness or Lightheadedness
Description

Dizziness or Lightheadedness

Data type

boolean

Alias
UMLS CUI [1]
C0012833
UMLS CUI [2]
C0220870
Fainting
Description

Fainting

Data type

boolean

Alias
UMLS CUI [1]
C0039070
Headache during first week of study drug administration
Description

Headache

Data type

boolean

Alias
UMLS CUI [1]
C0018681
If headache occurred please indicate how it was treated (indicate all that apply):
Description

If headache

Data type

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3146298
2. Have any Outcome Events or Serious Adverse Events been experienced? (See instructions on facing page)
Description

Outcome Events or Serious Adverse Events

Data type

boolean

Alias
UMLS CUI [1]
C1705586
UMLS CUI [2]
C0877248
if "Yes" please indicate all that apply
Description

If Yes

Data type

integer

Alias
UMLS CUI [1]
C2348235
Please complete the respective forms
Description

Please complete the respective forms

4. Signature of Investigator or Sub-Investigator
Description

By signing and dating this page, I declare that I have reviewed for accuracy all the case report form pages for this patient visit; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed on the specified dates.

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of Signature (dd mon yy)
Description

Date of Signature

Data type

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0011008
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Similar models

Visit 1A Events PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Events
C0877248 (UMLS CUI-1)
Patient experience
Item
1. Has the patient experienced any of the following since randomization:
text
C0596545 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Dizziness or Lightheadedness
Item
Dizziness or Lightheadedness
boolean
C0012833 (UMLS CUI [1])
C0220870 (UMLS CUI [2])
Fainting
Item
Fainting
boolean
C0039070 (UMLS CUI [1])
Headache
Item
Headache during first week of study drug administration
boolean
C0018681 (UMLS CUI [1])
Item
If headache occurred please indicate how it was treated (indicate all that apply):
integer
C0087111 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
If headache
Code List
If headache occurred please indicate how it was treated (indicate all that apply):
CL Item
Analgestic (1)
CL Item
Down titration of study medication A (2)
CL Item
No treatment (3)
Outcome Events or Serious Adverse Events
Item
2. Have any Outcome Events or Serious Adverse Events been experienced? (See instructions on facing page)
boolean
C1705586 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
Item
if "Yes" please indicate all that apply
integer
C2348235 (UMLS CUI [1])
If Yes
Code List
if "Yes" please indicate all that apply
CL Item
Stroke (1)
CL Item
Myocardial Infarction (2)
CL Item
Death (3)
CL Item
New or worsening congestive heart failure (CHF) (4)
CL Item
Other designated vascular event (5)
CL Item
Hemorrhagic Event (6)
CL Item
Thrombotic Thrombocytopenia purpura (7)
CL Item
Neutropenia (8)
CL Item
Newly diagnosed diabetes (9)
Item Group
Please complete the respective forms
Signature of Investigator or Sub-Investigator
Item
4. Signature of Investigator or Sub-Investigator
text
C2346576 (UMLS CUI [1])
Date of Signature
Item
Date of Signature (dd mon yy)
date
C1519316 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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