ID

20340

Descrição

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.

Palavras-chave

Versões (2)
  1. 15/02/2017 15/02/2017 -
  2. 20/02/2017 20/02/2017 -
Transferido a

20 de fevereiro de 2017

DOI

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Licença

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

Inglês

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

1 Formulários  
Visit
Descrição

Visit

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

Visit done

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0545082
If No, indicate reason:
Descrição

If No,reason

Tipo de dados

integer

Alias
UMLS CUI [1]
C0681841
3. If Yes date of visit (dd-mon-yy)
Descrição

If Yes date of visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
4. Type of visit
Descrição

Type of visit

Tipo de dados

integer

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

If not patient, indicate source

Tipo de dados

integer

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

Vital Signs

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

Systolic blood pressure

Tipo de dados

float

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

Diastolic Blood Pressure

Tipo de dados

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
7. Blood Pressure Position
Descrição

Blood Pressure Position

Tipo de dados

integer

Alias
UMLS CUI [1]
C1828063
Neurological Status
Descrição

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
Descrição

Clinical Neurological Status is different

Tipo de dados

integer

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

Modified Rankin Scale

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

Modified Rankin Scale to fill in

Tipo de dados

integer

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

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)
Descrição

Outcome Events or Serious Adverse Events

Tipo de dados

boolean

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

If Yes

Tipo de dados

integer

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

New Or Worsening Disease States

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

PAOD

Tipo de dados

boolean

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

PAOD Worsening

Tipo de dados

boolean

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

Foot ulcers/foot infection

Tipo de dados

boolean

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

Renal Dialysis

Tipo de dados

boolean

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

diabetic nephropathy

Tipo de dados

boolean

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

Other Nephropathy

Tipo de dados

boolean

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

Laser therapy for retinopathy

Tipo de dados

boolean

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

Cataract extraction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C0185115
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Similar models

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

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Visit
C0545082 (UMLS CUI-1)
Visit done
Item
1. Was visit done?
boolean
C0545082 (UMLS CUI [1])
Item
If No, indicate reason:
integer
C0681841 (UMLS CUI [1])
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
C1320303 (UMLS CUI [1])
Item
4. Type of visit
integer
C3641100 (UMLS CUI [1])
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
C0449416 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
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])
Diastolic Blood Pressure
Item
6. Diastolic Blood Pressure after 5 minutes sitting/supine
float
C0428883 (UMLS CUI [1])
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
C0038454 (UMLS CUI [1,1])
C2047944 (UMLS CUI [1,2])
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
C2984908 (UMLS CUI [1,1])
C2047944 (UMLS CUI [1,2])
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
C1705586 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
Item
11. If "YES" please indicate all that apply:
integer
C1521902 (UMLS CUI [1])
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
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])
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