0 Ratings
ID

20371

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. Visit 7 (Month 24) Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Link

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

Keywords

Versions (2)
  1. 21/02/2017 21/02/2017 -
  2. 21/02/2017 21/02/2017 -
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21 de fevereiro de 2017

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Creative Commons BY 4.0
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    Visit 7 Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

    English

    Visit 7 Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

    1 forms  
    Month 21 Phone Check Of Patient
    Description

    Month 21 Phone Check Of Patient

    Alias
    UMLS CUI-1
    C0039457
    UMLS CUI-2
    C1283174
    1. Was telephone check done?
    Description

    Telephone check

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0039457
    UMLS CUI [1,2]
    C1283174
    2. If Yes, date of phone call (dd-mon-yy)
    Description

    if Yes

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Visit
    Description

    Visit

    Alias
    UMLS CUI-1
    C0545082
    3. Was visit 7 done?
    Description

    Visit done

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0545082
    4. If No, indicate reason:
    Description

    If No,reason

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0681841
    5. If Yes date of visit 7 (dd-mon-yy)
    Description

    If Yes date of visit 3

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    6. Type of visit
    Description

    Type of visit

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3641100
    7. If not patient, indicate source (try to re-establish direct contact with patient)
    Description

    If not patient, indicate source

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0449416
    UMLS CUI [1,2]
    C3146298
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    8. Systolic blood pressure after 5 minutes sitting/supine
    Description

    Systolic blood pressure

    Data type

    float

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    8. Diastolic Blood Pressure after 5 minutes sitting/supine
    Description

    Diastolic Blood Pressure

    Data type

    float

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    9. Blood Pressure Position
    Description

    Blood Pressure Position

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1828063
    Neurological Status
    Description

    Neurological Status

    Alias
    UMLS CUI-1
    C0746866
    10. Please check careful whether the present clinical neurological status is different from baseline to determine if the patient may have experienced a stroke since the last visit
    Description

    Clinical Neurological Status is different

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0038454
    UMLS CUI [1,2]
    C2047944
    Modified Rankin Scale
    Description

    Modified Rankin Scale

    Alias
    UMLS CUI-1
    C2984908
    11. Please fill in the current Modified Rankin Scale below. (Indicate only one)
    Description

    Modified Rankin Scale to fill in

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2984908
    UMLS CUI [1,2]
    C2047944
    Events
    Description

    Events

    Alias
    UMLS CUI-1
    C0877248
    12. Have any Outcome Events or Serious Adverse Events been experienced, or has patient been hospitalised? (See instructions on facing page)
    Description

    Outcome Events or Serious Adverse Events

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1705586
    UMLS CUI [2]
    C0877248
    13. If "YES" please indicate all that apply:
    Description

    If Yes

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1521902
    New Or Worsening Disease States
    Description

    New Or Worsening Disease States

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C1442792
    1. New peripheral arterial occlusive disease (PAOD)
    Description

    PAOD

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1306889
    UMLS CUI [1,2]
    C0205314
    2. Worsening peripheral arterial occlusive disease (PAOD)
    Description

    PAOD Worsening

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1306889
    UMLS CUI [1,2]
    C0332271
    3. Foot ulcers/foot infection requiring antibiotics
    Description

    Foot ulcers/foot infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085119
    UMLS CUI [2,1]
    C0016504
    UMLS CUI [2,2]
    C3714514
    UMLS CUI [3]
    C0003232
    4. Renal Dialysis
    Description

    Renal Dialysis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011946
    5. Diabetic Nephropathy
    Description

    diabetic nephropathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011881
    6. Other Nephropathy
    Description

    Other Nephropathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0022658
    7. Laser therapy for retinopathy
    Description

    Laser therapy for retinopathy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0035309
    UMLS CUI [1,2]
    C1955835
    8. Cataract extraction
    Description

    Cataract extraction

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0086543
    UMLS CUI [1,2]
    C0185115
    ECG
    Description

    ECG

    Alias
    UMLS CUI-1
    C1623258
    9. Has an ECG been performed?
    Description

    ECG perfomance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0456984
    If Yes, record patient number, visit number, and date of tracing on the ECG printout and fax to the Trial Data Centre.
    Description

    If Yes

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830427
    UMLS CUI [2]
    C1549755
    UMLS CUI [3,1]
    C0013798
    UMLS CUI [3,2]
    C0011008
    10. Are there any new pathological Q waves since visit 1?
    Description

    Pathological Q waves

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1305738
    UMLS CUI [1,2]
    C1521733
    if Yes, in which leads (indicate all that apply)
    Description

    if Yes, in which leads

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0179504
    11. Does the ECG show left ventricular hypertrophy (LVH)?
    Description

    ECG shows LVH

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0149721
    12. If Yes, was this confirmed by the Modified Cornell Criteria (see facing page)?
    Description

    Modified Cornell Criteria

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0521093
    UMLS CUI [1,2]
    C0025102
    Tobacco Use Status
    Description

    Tobacco Use Status

    Alias
    UMLS CUI-1
    C0543414
    UMLS CUI-2
    C0449438
    13. Has the patient smoked in the last week?
    Description

    Smoked last week

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C2987125
    If the patient smoked cigarettes number of cigarettes per day
    Description

    Number of cigarettes per day

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C3694146
    Urinalysis
    Description

    Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    14. Has urine sample (preferably first morning) been collected for central analysis?
    Description

    Urine sample

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0200354
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    Similar models

    Visit 7 Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Month 21 Phone Check Of Patient
    C0039457 (UMLS CUI-1)
    C1283174 (UMLS CUI-2)
    Telephone check
    Item
    1. Was telephone check done?
    boolean
    C0039457 (UMLS CUI [1,1])
    C1283174 (UMLS CUI [1,2])
    if Yes
    Item
    2. If Yes, date of phone call (dd-mon-yy)
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Visit
    C0545082 (UMLS CUI-1)
    Visit done
    Item
    3. Was visit 7 done?
    boolean
    C0545082 (UMLS CUI [1])
    Item
    4. If No, indicate reason:
    integer
    C0681841 (UMLS CUI [1])
    If No,reason
    Code List
    4. If No, indicate reason:
    CL Item
    Died (complete respective outcome event form and End of Trial visit) (1)
    CL Item
    Patients refuses further participation (2)
    CL Item
    Unable to contact patient or other source (3)
    If Yes date of visit 3
    Item
    5. If Yes date of visit 7 (dd-mon-yy)
    date
    C1320303 (UMLS CUI [1])
    Item
    6. Type of visit
    integer
    C3641100 (UMLS CUI [1])
    Type of visit
    Code List
    6. Type of visit
    CL Item
    Clinic (in-person) (1)
    CL Item
    Telephone (2)
    CL Item
    Information obtained from source other than patient (3)
    Item
    7. If not patient, indicate source (try to re-establish direct contact with patient)
    integer
    C0449416 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    If not patient, indicate source
    Code List
    7. If not patient, indicate source (try to re-establish direct contact with patient)
    CL Item
    Physician (1)
    CL Item
    Relative or friend (2)
    CL Item
    Other (3)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Systolic blood pressure
    Item
    8. Systolic blood pressure after 5 minutes sitting/supine
    float
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    8. Diastolic Blood Pressure after 5 minutes sitting/supine
    float
    C0428883 (UMLS CUI [1])
    Item
    9. Blood Pressure Position
    integer
    C1828063 (UMLS CUI [1])
    Blood Pressure Position
    Code List
    9. Blood Pressure Position
    CL Item
    Sitting (1 )
    CL Item
    Supine (2 )
    Item Group
    Neurological Status
    C0746866 (UMLS CUI-1)
    Item
    10. Please check careful whether the present clinical neurological status is different from baseline to determine if the patient may have experienced a stroke since the last visit
    integer
    C0038454 (UMLS CUI [1,1])
    C2047944 (UMLS CUI [1,2])
    Clinical Neurological Status is different
    Code List
    10. Please check careful whether the present clinical neurological status is different from baseline to determine if the patient may have experienced a stroke since the last visit
    CL Item
    Unchanged (1)
    CL Item
    Improved (2)
    CL Item
    Worsened (3)
    Item Group
    Modified Rankin Scale
    C2984908 (UMLS CUI-1)
    Item
    11. Please fill in the current Modified Rankin Scale below. (Indicate only one)
    integer
    C2984908 (UMLS CUI [1,1])
    C2047944 (UMLS CUI [1,2])
    Modified Rankin Scale to fill in
    Code List
    11. Please fill in the current Modified Rankin Scale below. (Indicate only one)
    CL Item
    Grade 0 (1)
    CL Item
    Grade 1 (2)
    CL Item
    Grade 2 (3)
    CL Item
    Grade 3 (4)
    CL Item
    Grade 4 (5)
    CL Item
    Grade 5 (6)
    CL Item
    Grade 6(fatal) (7)
    Item Group
    Events
    C0877248 (UMLS CUI-1)
    Outcome Events or Serious Adverse Events
    Item
    12. Have any Outcome Events or Serious Adverse Events been experienced, or has patient been hospitalised? (See instructions on facing page)
    boolean
    C1705586 (UMLS CUI [1])
    C0877248 (UMLS CUI [2])
    Item
    13. If "YES" please indicate all that apply:
    integer
    C1521902 (UMLS CUI [1])
    If Yes
    Code List
    13. 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 Thrombocytopenic purpura (7)
    CL Item
    Neutropenia (8)
    CL Item
    Other Hospitalization (9)
    CL Item
    Newly diagnosed diabetes (10)
    Item Group
    New Or Worsening Disease States
    C0012634 (UMLS CUI-1)
    C1442792 (UMLS CUI-2)
    PAOD
    Item
    1. New peripheral arterial occlusive disease (PAOD)
    boolean
    C1306889 (UMLS CUI [1,1])
    C0205314 (UMLS CUI [1,2])
    PAOD Worsening
    Item
    2. Worsening peripheral arterial occlusive disease (PAOD)
    boolean
    C1306889 (UMLS CUI [1,1])
    C0332271 (UMLS CUI [1,2])
    Foot ulcers/foot infection
    Item
    3. Foot ulcers/foot infection requiring antibiotics
    boolean
    C0085119 (UMLS CUI [1])
    C0016504 (UMLS CUI [2,1])
    C3714514 (UMLS CUI [2,2])
    C0003232 (UMLS CUI [3])
    Renal Dialysis
    Item
    4. Renal Dialysis
    boolean
    C0011946 (UMLS CUI [1])
    diabetic nephropathy
    Item
    5. Diabetic Nephropathy
    boolean
    C0011881 (UMLS CUI [1])
    Other Nephropathy
    Item
    6. Other Nephropathy
    boolean
    C0022658 (UMLS CUI [1])
    Laser therapy for retinopathy
    Item
    7. Laser therapy for retinopathy
    boolean
    C0035309 (UMLS CUI [1,1])
    C1955835 (UMLS CUI [1,2])
    Cataract extraction
    Item
    8. Cataract extraction
    boolean
    C0086543 (UMLS CUI [1,1])
    C0185115 (UMLS CUI [1,2])
    Item Group
    ECG
    C1623258 (UMLS CUI-1)
    ECG perfomance
    Item
    9. Has an ECG been performed?
    boolean
    C1623258 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    If Yes
    Item
    If Yes, record patient number, visit number, and date of tracing on the ECG printout and fax to the Trial Data Centre.
    text
    C1830427 (UMLS CUI [1])
    C1549755 (UMLS CUI [2])
    C0013798 (UMLS CUI [3,1])
    C0011008 (UMLS CUI [3,2])
    Pathological Q waves
    Item
    10. Are there any new pathological Q waves since visit 1?
    boolean
    C1305738 (UMLS CUI [1,1])
    C1521733 (UMLS CUI [1,2])
    Item
    if Yes, in which leads (indicate all that apply)
    integer
    C0179504 (UMLS CUI [1])
    if Yes, in which leads
    Code List
    if Yes, in which leads (indicate all that apply)
    CL Item
    I (1)
    CL Item
    V6 (10)
    CL Item
    II (2)
    CL Item
    III (3)
    CL Item
    aVF (4)
    CL Item
    V1 (5)
    CL Item
    V2 (6)
    CL Item
    V3 (7)
    CL Item
    V4 (8)
    CL Item
    V5 (9)
    ECG shows LVH
    Item
    11. Does the ECG show left ventricular hypertrophy (LVH)?
    boolean
    C0149721 (UMLS CUI [1])
    Modified Cornell Criteria
    Item
    12. If Yes, was this confirmed by the Modified Cornell Criteria (see facing page)?
    boolean
    C0521093 (UMLS CUI [1,1])
    C0025102 (UMLS CUI [1,2])
    Item Group
    Tobacco Use Status
    C0543414 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Smoked last week
    Item
    13. Has the patient smoked in the last week?
    boolean
    C0543414 (UMLS CUI [1,1])
    C2987125 (UMLS CUI [1,2])
    Number of cigarettes per day
    Item
    If the patient smoked cigarettes number of cigarettes per day
    float
    C0543414 (UMLS CUI [1,1])
    C3694146 (UMLS CUI [1,2])
    Item Group
    Urinalysis
    C0042014 (UMLS CUI-1)
    Urine sample
    Item
    14. Has urine sample (preferably first morning) been collected for central analysis?
    boolean
    C0200354 (UMLS CUI [1])
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