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Information:
Fel:
ID
20430
Beskrivning
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. Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1
Länk
https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1
Nyckelord
Versioner (2)
- 2017-02-22 2017-02-22 -
- 2017-04-03 2017-04-03 -
Uppladdad den
22 februari 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Stroke Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062
Stroke Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062
Similar models
Stroke Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Study Medication Prior To Event
Item
1. Was the patient on study medication within the 7 days prior to the event?
boolean
Item
If NO, indicate which medication the patient was not taking (please indicate all that apply):
integer
C0030705 (UMLS CUI [1,1])
C0457432 (UMLS CUI [1,2])
C0457432 (UMLS CUI [1,2])
Code List
If NO, indicate which medication 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)
Date of onset stroke symptoms
Item
2. Date of onset stroke symptoms (dd mon yy)
date
Time of onset stroke symptoms
Item
3. Time of onset stroke symptoms (24 hour clock time-hh:mm)
time
CL Item
0-1 hour (1)
CL Item
1-24 hours (2)
CL Item
<24 hours (3)
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
CL Item
Present (1)
CL Item
Absent (2)
CL Item
Unknown (3)
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
CL Item
Left Normal (1)
CL Item
Left Abnormal (2)
CL Item
Left Unknown (3)
CL Item
Right Normal (4)
CL Item
Right Abnormal (5)
CL Item
Right Unknown (6)
CL Item
left hemispheric (1)
CL Item
right hemispheric (2)
CL Item
brainstem (3)
CL Item
bilateral (4)
CL Item
uncertain (5)
Item
23. Please indicate which of the following were done in conjunction with the stroke:
integer
Code List
23. Please indicate which of the following were done in conjunction with the stroke:
CL Item
Magnetic resonance imaging (1)
CL Item
Computerized Tomography (2)
CL Item
Diffusion weighted imaging (3)
CL Item
Perfusion imaging (4)
CL Item
Angiography (5)
CL Item
Doppler/Duplex (6)
CL Item
Treated with Thrombolytics (7)
CL Item
Treated with surgery (8)
CL Item
Other (9)
Specification
Item
Specify other:
text
C2348235 (UMLS CUI [1])
new stroke confirmed by brain imaging
Item
boolean
CL Item
Ischemic (infarction) (1)
CL Item
Subarachnoid hemorrhage (2)
CL Item
Intracerebral hemorrhage (3)
CL Item
Uncertain type (4)
Ischemic infarction
Item
Was new stroke confined to a central retinal arterial occlusion?
boolean
Item
2. For ischemic stroke, please categories the etiologic subtype below (indicate one only)
integer
C0038454 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
Code List
2. For ischemic stroke, please categories the etiologic subtype below (indicate one only)
CL Item
Large-artery atherosclerosis (1)
CL Item
Cardioembolism (2)
CL Item
Small-artery occlusion (lacune) (3)
CL Item
Acute stroke of other determined etiology (4)
CL Item
Stroke of underdetermined etiology (5)
Item
3. Please fill in the Modified Rankin Scale below. (indicate only one) ->Please keep patient on trial medication if possible. It is strongly recommended to continue the treatment until the end of the trial period despite the occurrence of a non-fatal stroke.
integer
C2984908 (UMLS CUI [1])
Code List
3. Please fill in the Modified Rankin Scale below. (indicate only one) ->Please keep patient on trial medication if possible. It is strongly recommended to continue the treatment until the end of the trial period despite the occurrence of a non-fatal stroke.
CL Item
Grad 0 (1)
CL Item
Grade 1 (2)
CL Item
Grade 2 (3)
CL Item
Grade 3 (4)
CL Item
Grade 4 (5)
CL Item
Grade 5 (6)
CL Item
Grade 6 (fatal) (7)
Fatal Event
Item
5. Was the event fatal (death within 28 days)? If yes please complete Death Report Form.
boolean
Item Group
Please remember to fax supporting documentation clearly identified with the patient number
Item
6. Please indicate which supporting documentation has been supplied:
integer
Code List
6. Please indicate which supporting documentation has been supplied:
CL Item
Brain Imaging (1)
CL Item
Vascular Imaging (2)
CL Item
Cardiac Evaluation (3)
CL Item
Other supporting testing (4)
Invenstigator´s Declaration
Item
8. Invenstigator´s Declaration 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
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])