ID

20877

Beschrijving

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

Trefwoorden

  1. 23-03-17 23-03-17 -
Geüploaded op

23 maart 2017

DOI

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Licentie

Creative Commons BY 4.0

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

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

Study Medication
Beschrijving

Study Medication

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

Patient on study medication

Datatype

boolean

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

if NO

Datatype

integer

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

Pulmonary embolism

Alias
UMLS CUI-1
C0034065
2. Pulmonary embolism
Beschrijving

Pulmonary embolism

Datatype

boolean

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

If Yes

Datatype

date

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

ancillary examination

Datatype

text

Alias
UMLS CUI [1]
C0582103
Angiography
Beschrijving

Angiography

Datatype

boolean

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

V/Q Scan

Datatype

boolean

Alias
UMLS CUI [1]
C0849974
Deep vein thrombosis
Beschrijving

Deep vein thrombosis

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

Deep vein thrombosis

Datatype

boolean

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

If Yes

Datatype

date

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

ancillary examination

Datatype

text

Alias
UMLS CUI [1]
C0582103
Doppler
Beschrijving

Doppler

Datatype

boolean

Alias
UMLS CUI [1]
C0242845
Angiography
Beschrijving

Angiography

Datatype

boolean

Alias
UMLS CUI [1]
C0002978
Scintigraphy
Beschrijving

Scintigraphy

Datatype

boolean

Alias
UMLS CUI [1]
C0034606
Retinal Vascular Events
Beschrijving

Retinal Vascular Events

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

Retinal Vascular accidents

Datatype

boolean

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

If Yes

Datatype

date

Alias
UMLS CUI [1]
C0011008
Peripheral arterial occlusion
Beschrijving

Peripheral arterial occlusion

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

Peripheral Arterial Occlusion

Datatype

boolean

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

If Yes

Datatype

date

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

ancillary examination

Datatype

text

Alias
UMLS CUI [1]
C0582103
Doppler
Beschrijving

Doppler

Datatype

boolean

Alias
UMLS CUI [1]
C0242845
Angiography
Beschrijving

Angiography

Datatype

boolean

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

claudication

Datatype

boolean

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

gangrene

Datatype

boolean

Alias
UMLS CUI [1]
C0017086
Ischemic Attack
Beschrijving

Ischemic Attack

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

Transient Ischemic Attack

Datatype

boolean

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

duration of event

Datatype

time

Alias
UMLS CUI [1]
C0449238
Hospitalization
Beschrijving

Hospitalization

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

If Yes please complete the Hospitalization Report Form

Datatype

boolean

Alias
UMLS CUI [1]
C0019993
Fatal Outcome
Beschrijving

Fatal Outcome

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

Fatal Event

Datatype

boolean

Invenstigator´s Declaration
Beschrijving

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.
Beschrijving

Invenstigator´s Declaration

Datatype

text

Investigator´s signature
Beschrijving

Investigator´s signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Beschrijving

Date of Signature

Datatype

date

Alias
UMLS CUI [1]
C0807937

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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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