ID

20233

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.

Mots-clés

  1. 15/02/2017 15/02/2017 -
  2. 20/02/2017 20/02/2017 -
Téléchargé le

15 février 2017

DOI

Pour une demande vous connecter.

Licence

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
Description

Visit

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

Visit done

Type de données

boolean

If No, indicate reason:
Description

If No,reason

Type de données

integer

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

If Yes date of visit

Type de données

date

4. Type of visit
Description

Type of visit

Type de données

integer

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

If not patient, indicate source

Type de données

integer

Vital Signs
Description

Vital Signs

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

Systolic blood pressure

Type de données

float

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

Diastolic Blood Pressure

Type de données

float

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0518766
mmHg
7. Blood Pressure Position
Description

Blood Pressure Position

Type de données

integer

Alias
UMLS CUI [1]
C1828063
Neurological Status
Description

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
Description

Clinical Neurological Status is different

Type de données

integer

Modified Rankin Scale
Description

Modified Rankin Scale

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

Modified Rankin Scale to fill in

Type de données

integer

Events
Description

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)
Description

Outcome Events or Serious Adverse Events

Type de données

boolean

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

If Yes

Type de données

integer

New Or Worsening Disease States
Description

New Or Worsening Disease States

1. New peripheral arterial occlusive disease (PAOD)
Description

PAOD

Type de données

boolean

2. Worsening peripheral arterial occlusive disease (PAOD)
Description

PAOD Worsening

Type de données

boolean

3. Foot ulcers/foot infection requiring antibiotics
Description

Foot ulcers/foot infection

Type de données

boolean

4. Renal Dialysis
Description

Renal Dialysis

Type de données

boolean

5. Diabetic Nephropathy
Description

diabetic nephropathy

Type de données

boolean

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

Other Nephropathy

Type de données

boolean

7. Laser therapy for retinopathy
Description

Laser therapy for retinopathy

Type de données

boolean

8. Cataract extraction
Description

Cataract extraction

Type de données

boolean

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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