ID

20877

Descripción

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

Palabras clave

Versiones (1)
  1. 23/3/17 23/3/17 -
Subido en

23 de marzo de 2017

DOI

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Licencia

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

Inglés

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

1 formularios  
Study Medication
Descripción

Study Medication

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

Patient on study medication

Tipo de datos

boolean

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

if NO

Tipo de datos

integer

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

Pulmonary embolism

Alias
UMLS CUI-1
C0034065
2. Pulmonary embolism
Descripción

Pulmonary embolism

Tipo de datos

boolean

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

If Yes

Tipo de datos

date

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

ancillary examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0582103
Angiography
Descripción

Angiography

Tipo de datos

boolean

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

V/Q Scan

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0849974
Deep vein thrombosis
Descripción

Deep vein thrombosis

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

Deep vein thrombosis

Tipo de datos

boolean

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

If Yes

Tipo de datos

date

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

ancillary examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0582103
Doppler
Descripción

Doppler

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242845
Angiography
Descripción

Angiography

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002978
Scintigraphy
Descripción

Scintigraphy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0034606
Retinal Vascular Events
Descripción

Retinal Vascular Events

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

Retinal Vascular accidents

Tipo de datos

boolean

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

If Yes

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Peripheral arterial occlusion
Descripción

Peripheral arterial occlusion

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

Peripheral Arterial Occlusion

Tipo de datos

boolean

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

If Yes

Tipo de datos

date

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

ancillary examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0582103
Doppler
Descripción

Doppler

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242845
Angiography
Descripción

Angiography

Tipo de datos

boolean

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

claudication

Tipo de datos

boolean

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

gangrene

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017086
Ischemic Attack
Descripción

Ischemic Attack

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

Transient Ischemic Attack

Tipo de datos

boolean

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

duration of event

Tipo de datos

time

Alias
UMLS CUI [1]
C0449238
Hospitalization
Descripción

Hospitalization

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

If Yes please complete the Hospitalization Report Form

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019993
Fatal Outcome
Descripción

Fatal Outcome

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

Fatal Event

Tipo de datos

boolean

Invenstigator´s Declaration
Descripción

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.
Descripción

Invenstigator´s Declaration

Tipo de datos

text

Investigator´s signature
Descripción

Investigator´s signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Descripción

Date of Signature

Tipo de datos

date

Alias
UMLS CUI [1]
C0807937
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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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