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ID

20420

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 (1)
  1. 22-02-17 22-02-17 -
Geüploaded op

22 februari 2017

DOI

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Licentie

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

    Engels

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

    1 Formulieren  
    Permanent Trial Medication
    Beschrijving

    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)
    Beschrijving

    Last Intake of Drug A, B and C

    Datatype

    date

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

    Last Intake of Drug D

    Datatype

    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
    Beschrijving

    Permanently stopped taking medication

    Datatype

    boolean

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

    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):
    Beschrijving

    If Yes

    Datatype

    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)
    Beschrijving

    Outcome events

    Datatype

    integer

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

    Adverse Event

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0877248
    Specify Adverse Event
    Beschrijving

    Adverse Event

    Datatype

    text

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

    Non Compliant With Protocol

    Datatype

    integer

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

    Lost to follow-up

    Datatype

    integer

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    E. Consent withdrawn (not due to adverse event, explain below)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

    Consent withdrawn

    Datatype

    integer

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

    Other

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0205394
    Explain
    Beschrijving

    Explain

    Datatype

    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 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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