ID

20387

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. End of Trial Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Keywords

Versions (1)
  1. 2/21/17 2/21/17 -
Uploaded on

February 21, 2017

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Creative Commons BY 4.0
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End of Trial Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

English

End of Trial Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 forms  
Phone Check Of Patient
Description

Phone Check Of Patient

Alias
UMLS CUI-1
C0039457
UMLS CUI-2
C1283174
1. Has a phone check been done since last visit?
Description

Telephone check

Data type

boolean

Alias
UMLS CUI [1,1]
C0039457
UMLS CUI [1,2]
C1283174
2. If Yes, date of phone call (dd-mon-yy)
Description

if Yes

Data type

date

Alias
UMLS CUI [1]
C0011008
Visit
Description

Visit

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

Visit done

Data type

boolean

Alias
UMLS CUI [1]
C0545082
4. If No, please indicate reason:
Description

If No,reason

Data type

integer

Alias
UMLS CUI [1]
C0681841
5. If Yes date of end of trial visit (dd-mon-yy)
Description

If Yes date of end of trial visit

Data type

date

Alias
UMLS CUI [1]
C1320303
6. Type of visit
Description

Type of visit

Data type

integer

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

If not patient, indicate source

Data type

integer

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

Vital Signs

Alias
UMLS CUI-1
C0518766
8. Abdominal girth (Waist Circumference)
Description

Abdominal girth

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0232501
cm
9. Systolic blood pressure after 5 minutes sitting/supine
Description

Systolic blood pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
9. Diastolic Blood Pressure after 5 minutes sitting/supine
Description

Diastolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
10. Blood Pressure Position
Description

Blood Pressure Position

Data type

integer

Alias
UMLS CUI [1]
C1828063
Neurological Status
Description

Neurological Status

Alias
UMLS CUI-1
C0746866
11. 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

Data type

integer

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C2047944
Events
Description

Events

Alias
UMLS CUI-1
C0877248
12. 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

Data type

boolean

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

If Yes

Data type

integer

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

New Or Worsening Disease States

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

PAOD

Data type

boolean

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

PAOD Worsening

Data type

boolean

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

Foot ulcers/foot infection

Data type

boolean

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

Renal Dialysis

Data type

boolean

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

diabetic nephropathy

Data type

boolean

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

Other Nephropathy

Data type

boolean

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

Laser therapy for retinopathy

Data type

boolean

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

Cataract extraction

Data type

boolean

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C0185115
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
9. Has an ECG been performed?
Description

ECG perfomance

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
If Yes, record patient number, visit number, and date of tracing on the ECG printout and fax to the Trial Data Centre.
Description

If Yes

Data type

text

Alias
UMLS CUI [1]
C1830427
UMLS CUI [2]
C1549755
UMLS CUI [3,1]
C0013798
UMLS CUI [3,2]
C0011008
10. Are there any new pathological Q waves since visit 1?
Description

Pathological Q waves

Data type

boolean

Alias
UMLS CUI [1,1]
C1305738
UMLS CUI [1,2]
C1521733
if Yes, in which leads (indicate all that apply)
Description

if Yes, in which leads

Data type

integer

Alias
UMLS CUI [1]
C0179504
11. Does the ECG show left ventricular hypertrophy (LVH)?
Description

ECG shows LVH

Data type

boolean

Alias
UMLS CUI [1]
C0149721
12. If Yes, was this confirmed by the Modified Cornell Criteria (see facing page)?
Description

Modified Cornell Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0521093
UMLS CUI [1,2]
C0025102
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
14. Has urine sample (preferably first morning) been collected for central analysis?
Description

Urine sample

Data type

boolean

Alias
UMLS CUI [1]
C0200354
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Similar models

End of Trial Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Phone Check Of Patient
C0039457 (UMLS CUI-1)
C1283174 (UMLS CUI-2)
Telephone check
Item
1. Has a phone check been done since last visit?
boolean
C0039457 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
if Yes
Item
2. If Yes, date of phone call (dd-mon-yy)
date
C0011008 (UMLS CUI [1])
Item Group
Visit
C0545082 (UMLS CUI-1)
Visit done
Item
3. Was visit done?
boolean
C0545082 (UMLS CUI [1])
Item
4. If No, please indicate reason:
integer
C0681841 (UMLS CUI [1])
If No,reason
Code List
4. If No, please 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 end of trial visit
Item
5. If Yes date of end of trial visit (dd-mon-yy)
date
C1320303 (UMLS CUI [1])
Item
6. Type of visit
integer
C3641100 (UMLS CUI [1])
Type of visit
Code List
6. Type of visit
CL Item
Clinic (in-person) (1)
CL Item
Telephone (2)
CL Item
Information obtained from source other than patient (3)
Item
7. 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
7. 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)
Abdominal girth
Item
8. Abdominal girth (Waist Circumference)
float
C0232501 (UMLS CUI [1])
Systolic blood pressure
Item
9. Systolic blood pressure after 5 minutes sitting/supine
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
9. Diastolic Blood Pressure after 5 minutes sitting/supine
float
C0428883 (UMLS CUI [1])
Item
10. Blood Pressure Position
integer
C1828063 (UMLS CUI [1])
Blood Pressure Position
Code List
10. Blood Pressure Position
CL Item
Sitting (1 )
CL Item
Supine (2 )
Item Group
Neurological Status
C0746866 (UMLS CUI-1)
Item
11. 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
11. 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
Events
C0877248 (UMLS CUI-1)
Outcome Events or Serious Adverse Events
Item
12. 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
13. If "YES" please indicate all that apply:
integer
C1521902 (UMLS CUI [1])
If Yes
Code List
13. 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])
Item Group
ECG
C1623258 (UMLS CUI-1)
ECG perfomance
Item
9. Has an ECG been performed?
boolean
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
If Yes
Item
If Yes, record patient number, visit number, and date of tracing on the ECG printout and fax to the Trial Data Centre.
text
C1830427 (UMLS CUI [1])
C1549755 (UMLS CUI [2])
C0013798 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
Pathological Q waves
Item
10. Are there any new pathological Q waves since visit 1?
boolean
C1305738 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
Item
if Yes, in which leads (indicate all that apply)
integer
C0179504 (UMLS CUI [1])
if Yes, in which leads
Code List
if Yes, in which leads (indicate all that apply)
CL Item
I (1)
CL Item
V6 (10)
CL Item
II (2)
CL Item
III (3)
CL Item
aVF (4)
CL Item
V1 (5)
CL Item
V2 (6)
CL Item
V3 (7)
CL Item
V4 (8)
CL Item
V5 (9)
ECG shows LVH
Item
11. Does the ECG show left ventricular hypertrophy (LVH)?
boolean
C0149721 (UMLS CUI [1])
Modified Cornell Criteria
Item
12. If Yes, was this confirmed by the Modified Cornell Criteria (see facing page)?
boolean
C0521093 (UMLS CUI [1,1])
C0025102 (UMLS CUI [1,2])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Urine sample
Item
14. Has urine sample (preferably first morning) been collected for central analysis?
boolean
C0200354 (UMLS CUI [1])
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