ID

20233

Descripción

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.

Palabras clave

Versiones (2)
  1. 15/2/17 15/2/17 -
  2. 20/2/17 20/2/17 -
Subido en

15 de febrero de 2017

DOI

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Licencia

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

Inglés

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

1 formularios  
Visit
Descripción

Visit

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

Visit done

Tipo de datos

boolean

If No, indicate reason:
Descripción

If No,reason

Tipo de datos

integer

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

If Yes date of visit

Tipo de datos

date

4. Type of visit
Descripción

Type of visit

Tipo de datos

integer

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

If not patient, indicate source

Tipo de datos

integer

Vital Signs
Descripción

Vital Signs

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

Systolic blood pressure

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0518766
mmHg
6. Diastolic Blood Pressure after 5 minutes sitting/supine
Descripción

Diastolic Blood Pressure

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0518766
mmHg
7. Blood Pressure Position
Descripción

Blood Pressure Position

Tipo de datos

integer

Alias
UMLS CUI [1]
C1828063
Neurological Status
Descripción

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
Descripción

Clinical Neurological Status is different

Tipo de datos

integer

Modified Rankin Scale
Descripción

Modified Rankin Scale

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

Modified Rankin Scale to fill in

Tipo de datos

integer

Events
Descripción

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)
Descripción

Outcome Events or Serious Adverse Events

Tipo de datos

boolean

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

If Yes

Tipo de datos

integer

New Or Worsening Disease States
Descripción

New Or Worsening Disease States

1. New peripheral arterial occlusive disease (PAOD)
Descripción

PAOD

Tipo de datos

boolean

2. Worsening peripheral arterial occlusive disease (PAOD)
Descripción

PAOD Worsening

Tipo de datos

boolean

3. Foot ulcers/foot infection requiring antibiotics
Descripción

Foot ulcers/foot infection

Tipo de datos

boolean

4. Renal Dialysis
Descripción

Renal Dialysis

Tipo de datos

boolean

5. Diabetic Nephropathy
Descripción

diabetic nephropathy

Tipo de datos

boolean

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

Other Nephropathy

Tipo de datos

boolean

7. Laser therapy for retinopathy
Descripción

Laser therapy for retinopathy

Tipo de datos

boolean

8. Cataract extraction
Descripción

Cataract extraction

Tipo de datos

boolean

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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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