ID

20233

Descrizione

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

versioni (2)
  1. 15/02/17 15/02/17 -
  2. 20/02/17 20/02/17 -
Caricato su

15 febbraio 2017

DOI

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Licenza

Creative Commons BY-NC 3.0
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Visit 2 Treatment PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Inglese

Visit 2 Treatment PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 moduli  
Visit
Descrizione

Visit

Alias
UMLS CUI-1
C0545082
1. Was visit done?
Descrizione

Visit done

Tipo di dati

boolean

If No, indicate reason:
Descrizione

If No,reason

Tipo di dati

integer

3. If Yes date of visit (dd-mon-yy)
Descrizione

If Yes date of visit

Tipo di dati

date

4. Type of visit
Descrizione

Type of visit

Tipo di dati

integer

5. If not patient, indicate source (try to re-establish direct contact with patient)
Descrizione

If not patient, indicate source

Tipo di dati

integer

Vital Signs
Descrizione

Vital Signs

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

Systolic blood pressure

Tipo di dati

float

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0518766
mmHg
6. Diastolic Blood Pressure after 5 minutes sitting/supine
Descrizione

Diastolic Blood Pressure

Tipo di dati

float

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0518766
mmHg
7. Blood Pressure Position
Descrizione

Blood Pressure Position

Tipo di dati

integer

Alias
UMLS CUI [1]
C1828063
Neurological Status
Descrizione

Neurological Status

Alias
UMLS CUI-1
C0746866
8. 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
Descrizione

Clinical Neurological Status is different

Tipo di dati

integer

Modified Rankin Scale
Descrizione

Modified Rankin Scale

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

Modified Rankin Scale to fill in

Tipo di dati

integer

Events
Descrizione

Events

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

Outcome Events or Serious Adverse Events

Tipo di dati

boolean

11. If "YES" please indicate all that apply:
Descrizione

If Yes

Tipo di dati

integer

New Or Worsening Disease States
Descrizione

New Or Worsening Disease States

1. New peripheral arterial occlusive disease (PAOD)
Descrizione

PAOD

Tipo di dati

boolean

2. Worsening peripheral arterial occlusive disease (PAOD)
Descrizione

PAOD Worsening

Tipo di dati

boolean

3. Foot ulcers/foot infection requiring antibiotics
Descrizione

Foot ulcers/foot infection

Tipo di dati

boolean

4. Renal Dialysis
Descrizione

Renal Dialysis

Tipo di dati

boolean

5. Diabetic Nephropathy
Descrizione

diabetic nephropathy

Tipo di dati

boolean

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

Other Nephropathy

Tipo di dati

boolean

7. Laser therapy for retinopathy
Descrizione

Laser therapy for retinopathy

Tipo di dati

boolean

8. Cataract extraction
Descrizione

Cataract extraction

Tipo di dati

boolean

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Similar models

Visit 2 Treatment PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Visit
C0545082 (UMLS CUI-1)
Visit done
Item
1. Was visit done?
boolean
Item
If No, indicate reason:
integer
If No,reason
Code List
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
Item
3. If Yes date of visit (dd-mon-yy)
date
Item
4. Type of visit
integer
Type of visit
Code List
4. Type of visit
CL Item
Clinic (in-person) (1)
CL Item
Telephone (2)
CL Item
Information obtained from source other than patient (3)
Item
5. If not patient, indicate source (try to re-establish direct contact with patient)
integer
If not patient, indicate source
Code List
5. 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
6. Systolic blood pressure after 5 minutes sitting/supine
float
C0871470 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Diastolic Blood Pressure
Item
6. Diastolic Blood Pressure after 5 minutes sitting/supine
float
C0428883 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Item
7. Blood Pressure Position
integer
C1828063 (UMLS CUI [1])
Blood Pressure Position
Code List
7. Blood Pressure Position
CL Item
Sitting (1 )
CL Item
Supine (2 )
Item Group
Neurological Status
C0746866 (UMLS CUI-1)
Item
8. 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
Clinical Neurological Status is different
Code List
8. 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
9. Please fill in the current Modified Rankin Scale below. (Indicate only one)
integer
Modified Rankin Scale to fill in
Code List
9. Please fill in the current Modified Rankin Scale below. (Indicate only one)
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3  (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Grade 6 (fatal) (6)
Item Group
Events
C0877248 (UMLS CUI-1)
Outcome Events or Serious Adverse Events
Item
10. Have any Outcome Events or Serious Adverse Events been experienced, or has patient been hospitalised? (See instructions on facing page)
boolean
Item
11. If "YES" please indicate all that apply:
integer
If Yes
Code List
11. 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
PAOD
Item
1. New peripheral arterial occlusive disease (PAOD)
boolean
PAOD Worsening
Item
2. Worsening peripheral arterial occlusive disease (PAOD)
boolean
Foot ulcers/foot infection
Item
3. Foot ulcers/foot infection requiring antibiotics
boolean
Renal Dialysis
Item
4. Renal Dialysis
boolean
diabetic nephropathy
Item
5. Diabetic Nephropathy
boolean
C0011881 (UMLS CUI [1])
Other Nephropathy
Item
6. Other Nephropathy
boolean
Laser therapy for retinopathy
Item
7. Laser therapy for retinopathy
boolean
Cataract extraction
Item
8. Cataract extraction
boolean
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