ID

20877

Beschreibung

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

Link

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

Stichworte

Versionen (1)
  1. 23.03.17 23.03.17 -
Hochgeladen am

23. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Other Designated Vascular Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Englisch

Other Designated Vascular Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulare  
Study Medication
Beschreibung

Study Medication

Alias
UMLS CUI-1
C0013227
1. Was the patient on study medication within the 7 days prior to event?
Beschreibung

Patient on study medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
If NO, which medication was the patient was not taking (please indicate all that apply):
Beschreibung

if NO

Datentyp

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0457432
Pulmonary embolism
Beschreibung

Pulmonary embolism

Alias
UMLS CUI-1
C0034065
2. Pulmonary embolism
Beschreibung

Pulmonary embolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0034065
If Yes please complete the date of event (dd mon yy)
Beschreibung

If Yes

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Please indicate the supporting ancillary examinations:
Beschreibung

ancillary examination

Datentyp

text

Alias
UMLS CUI [1]
C0582103
Angiography
Beschreibung

Angiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0002978
V/Q Scan
Beschreibung

V/Q Scan

Datentyp

boolean

Alias
UMLS CUI [1]
C0849974
Deep vein thrombosis
Beschreibung

Deep vein thrombosis

Alias
UMLS CUI-1
C0149871
3. Deep vein thrombosis
Beschreibung

Deep vein thrombosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0149871
If Yes please complete the date of event (dd mon yy)
Beschreibung

If Yes

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Please indicate the supporting ancillary examinations:
Beschreibung

ancillary examination

Datentyp

text

Alias
UMLS CUI [1]
C0582103
Doppler
Beschreibung

Doppler

Datentyp

boolean

Alias
UMLS CUI [1]
C0242845
Angiography
Beschreibung

Angiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0002978
Scintigraphy
Beschreibung

Scintigraphy

Datentyp

boolean

Alias
UMLS CUI [1]
C0034606
Retinal Vascular Events
Beschreibung

Retinal Vascular Events

Alias
UMLS CUI-1
C0035309
4. Retinal Vascular accidents (not confirmed as retinal arterial occlusion)
Beschreibung

Retinal Vascular accidents

Datentyp

boolean

Alias
UMLS CUI [1]
C0035309
If Yes please complete the date of event (dd mon yy)
Beschreibung

If Yes

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Peripheral arterial occlusion
Beschreibung

Peripheral arterial occlusion

Alias
UMLS CUI-1
C1306889
5. Peripheral Arterial Occlusion
Beschreibung

Peripheral Arterial Occlusion

Datentyp

boolean

Alias
UMLS CUI [1]
C1306889
If Yes please complete the date of event (dd mon yy)
Beschreibung

If Yes

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Please indicate the supporting ancillary examinations:
Beschreibung

ancillary examination

Datentyp

text

Alias
UMLS CUI [1]
C0582103
Doppler
Beschreibung

Doppler

Datentyp

boolean

Alias
UMLS CUI [1]
C0242845
Angiography
Beschreibung

Angiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0002978
Were clinical symptoms of claudication observed?
Beschreibung

claudication

Datentyp

boolean

Alias
UMLS CUI [1]
C1456822
Was gangrene observed?
Beschreibung

gangrene

Datentyp

boolean

Alias
UMLS CUI [1]
C0017086
Ischemic Attack
Beschreibung

Ischemic Attack

Alias
UMLS CUI-1
C0007787
6. Transient Ischemic Attack
Beschreibung

Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0007787
If Yes please complete the duration of event
Beschreibung

duration of event

Datentyp

time

Alias
UMLS CUI [1]
C0449238
Hospitalization
Beschreibung

Hospitalization

Alias
UMLS CUI-1
C0019993
7. Did the lead to hospitalization? If Yes please complete the Hospitalization Report Form.
Beschreibung

If Yes please complete the Hospitalization Report Form

Datentyp

boolean

Alias
UMLS CUI [1]
C0019993
Fatal Outcome
Beschreibung

Fatal Outcome

Alias
UMLS CUI-1
C1705586
8. Was the event fatal (death within 28 days)? If yes please complete Death Report Form.
Beschreibung

Fatal Event

Datentyp

boolean

Invenstigator´s Declaration
Beschreibung

Invenstigator´s Declaration

Alias
UMLS CUI-1
C0008961
9. By signing and dating this page, I declare that I have reviewed for accuracy all case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed in the dates specified.
Beschreibung

Invenstigator´s Declaration

Datentyp

text

Investigator´s signature
Beschreibung

Investigator´s signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Beschreibung

Date of Signature

Datentyp

date

Alias
UMLS CUI [1]
C0807937
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Ähnliche Modelle

Other Designated Vascular Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Study Medication
C0013227 (UMLS CUI-1)
Patient on study medication
Item
1. Was the patient on study medication within the 7 days prior to event?
boolean
C0013227 (UMLS CUI [1])
Item
If NO, which medication was the patient was not taking (please indicate all that apply):
integer
C0030705 (UMLS CUI [1,1])
C0457432 (UMLS CUI [1,2])
if NO
Code List
If NO, which medication was the patient was not taking (please indicate all that apply):
CL Item
Bottle A (1)
CL Item
Bottle B (2)
CL Item
Blister card C (3)
CL Item
Blister card D (4)
Item Group
Pulmonary embolism
C0034065 (UMLS CUI-1)
Pulmonary embolism
Item
2. Pulmonary embolism
boolean
C0034065 (UMLS CUI [1])
If Yes
Item
If Yes please complete the date of event (dd mon yy)
date
C0011008 (UMLS CUI [1])
ancillary examination
Item
Please indicate the supporting ancillary examinations:
text
C0582103 (UMLS CUI [1])
Angiography
Item
Angiography
boolean
C0002978 (UMLS CUI [1])
V/Q Scan
Item
V/Q Scan
boolean
C0849974 (UMLS CUI [1])
Item Group
Deep vein thrombosis
C0149871 (UMLS CUI-1)
Deep vein thrombosis
Item
3. Deep vein thrombosis
boolean
C0149871 (UMLS CUI [1])
If Yes
Item
If Yes please complete the date of event (dd mon yy)
date
C0011008 (UMLS CUI [1])
ancillary examination
Item
Please indicate the supporting ancillary examinations:
text
C0582103 (UMLS CUI [1])
Doppler
Item
Doppler
boolean
C0242845 (UMLS CUI [1])
Angiography
Item
Angiography
boolean
C0002978 (UMLS CUI [1])
Scintigraphy
Item
Scintigraphy
boolean
C0034606 (UMLS CUI [1])
Item Group
Retinal Vascular Events
C0035309 (UMLS CUI-1)
Retinal Vascular accidents
Item
4. Retinal Vascular accidents (not confirmed as retinal arterial occlusion)
boolean
C0035309 (UMLS CUI [1])
If Yes
Item
If Yes please complete the date of event (dd mon yy)
date
C0011008 (UMLS CUI [1])
Item Group
Peripheral arterial occlusion
C1306889 (UMLS CUI-1)
Peripheral Arterial Occlusion
Item
5. Peripheral Arterial Occlusion
boolean
C1306889 (UMLS CUI [1])
If Yes
Item
If Yes please complete the date of event (dd mon yy)
date
C0011008 (UMLS CUI [1])
ancillary examination
Item
Please indicate the supporting ancillary examinations:
text
C0582103 (UMLS CUI [1])
Doppler
Item
Doppler
boolean
C0242845 (UMLS CUI [1])
Angiography
Item
Angiography
boolean
C0002978 (UMLS CUI [1])
claudication
Item
Were clinical symptoms of claudication observed?
boolean
C1456822 (UMLS CUI [1])
gangrene
Item
Was gangrene observed?
boolean
C0017086 (UMLS CUI [1])
Item Group
Ischemic Attack
C0007787 (UMLS CUI-1)
Transient Ischemic Attack
Item
6. Transient Ischemic Attack
boolean
C0007787 (UMLS CUI [1])
duration of event
Item
If Yes please complete the duration of event
time
C0449238 (UMLS CUI [1])
Item Group
Hospitalization
C0019993 (UMLS CUI-1)
Hospitalization
Item
7. Did the lead to hospitalization? If Yes please complete the Hospitalization Report Form.
boolean
C0019993 (UMLS CUI [1])
Item Group
Fatal Outcome
C1705586 (UMLS CUI-1)
Fatal Event
Item
8. Was the event fatal (death within 28 days)? If yes please complete Death Report Form.
boolean
Item Group
Invenstigator´s Declaration
C0008961 (UMLS CUI-1)
Invenstigator´s Declaration
Item
9. By signing and dating this page, I declare that I have reviewed for accuracy all case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed in the dates specified.
text
Investigator´s signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C0807937 (UMLS CUI [1])
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