ID

20233

Beskrivning

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.

Nyckelord

  1. 2017-02-15 2017-02-15 -
  2. 2017-02-20 2017-02-20 -
Uppladdad den

15 februari 2017

DOI

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Licens

Creative Commons BY-NC 3.0

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

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

Visit
Beskrivning

Visit

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

Visit done

Datatyp

boolean

If No, indicate reason:
Beskrivning

If No,reason

Datatyp

integer

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

If Yes date of visit

Datatyp

date

4. Type of visit
Beskrivning

Type of visit

Datatyp

integer

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

If not patient, indicate source

Datatyp

integer

Vital Signs
Beskrivning

Vital Signs

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

Systolic blood pressure

Datatyp

float

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0518766
mmHg
6. Diastolic Blood Pressure after 5 minutes sitting/supine
Beskrivning

Diastolic Blood Pressure

Datatyp

float

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0518766
mmHg
7. Blood Pressure Position
Beskrivning

Blood Pressure Position

Datatyp

integer

Alias
UMLS CUI [1]
C1828063
Neurological Status
Beskrivning

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
Beskrivning

Clinical Neurological Status is different

Datatyp

integer

Modified Rankin Scale
Beskrivning

Modified Rankin Scale

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

Modified Rankin Scale to fill in

Datatyp

integer

Events
Beskrivning

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)
Beskrivning

Outcome Events or Serious Adverse Events

Datatyp

boolean

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

If Yes

Datatyp

integer

New Or Worsening Disease States
Beskrivning

New Or Worsening Disease States

1. New peripheral arterial occlusive disease (PAOD)
Beskrivning

PAOD

Datatyp

boolean

2. Worsening peripheral arterial occlusive disease (PAOD)
Beskrivning

PAOD Worsening

Datatyp

boolean

3. Foot ulcers/foot infection requiring antibiotics
Beskrivning

Foot ulcers/foot infection

Datatyp

boolean

4. Renal Dialysis
Beskrivning

Renal Dialysis

Datatyp

boolean

5. Diabetic Nephropathy
Beskrivning

diabetic nephropathy

Datatyp

boolean

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

Other Nephropathy

Datatyp

boolean

7. Laser therapy for retinopathy
Beskrivning

Laser therapy for retinopathy

Datatyp

boolean

8. Cataract extraction
Beskrivning

Cataract extraction

Datatyp

boolean

Similar models

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

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Visit
C0545082 (UMLS CUI-1)
Visit done
Item
1. Was visit done?
boolean
Item
If No, indicate reason:
integer
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
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
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])
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
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
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
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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