Informatie:
Fout:
ID
42247
Beschrijving
Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS. https://clinicaltrials.gov/ct2/show/NCT00391872
Link
https://clinicaltrials.gov/ct2/show/NCT00391872
Trefwoorden
Versies (3)
- 28-11-15 28-11-15 -
- 14-04-21 14-04-21 - Ahmed Rafee, MD
- 15-04-21 15-04-21 - Ahmed Rafee, MD
Houder van rechten
AstraZeneca
Geüploaded op
15 april 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Excerpt PLATO Acute coronary Syndrome NCT00391872
Section Event Forms
Similar models
Section Event Forms
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Event tracking number
Item
Event tracking number
text
C0441471 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Time of death
Item
Time of death
time
C1301931 (UMLS CUI [1])
Autopsy performed
Item
Autopsy performed
boolean
C0004398 (UMLS CUI [1])
Death witnessed
Item
Death witnessed
boolean
C2924291 (UMLS CUI [1])
CL Item
Vascular (Vascular)
I (UMLS CUI-1)
CL Item
Non-vascular (Non-vascular)
I (UMLS CUI-1)
CL Item
Unknown (Unknown)
I (UMLS CUI-1)
CL Item
Sudden death (Sudden death)
CL Item
Myocardial infarction (Myocardial infarction)
CL Item
Unstable angina (Unstable angina)
CL Item
Other coronary artery disease (Other coronary artery disease)
CL Item
Stroke (Stroke)
CL Item
Arterial embolism (Arterial embolism)
CL Item
Pulmonary embolism (Pulmonary embolism)
CL Item
Ruptured aortic aneurysm (Ruptured aortic aneurysm)
CL Item
Aortic dissection (Aortic dissection)
CL Item
Heart failure (Heart failure)
CL Item
Cardiac arrhythmia (Cardiac arrhythmia)
CL Item
Death from bleeding (not related to trauma) (Death from bleeding (not related to trauma))
CL Item
Endocarditis (Endocarditis)
CL Item
Valvular disease (Valvular disease)
CL Item
Other (Other)
Item
If Non-vascular death, Sub-classification
text
C0007465 (UMLS CUI [1])
CL Item
Respiratory failure (Respiratory failure)
CL Item
Pneumonia (Pneumonia)
CL Item
Cancer (Cancer)
CL Item
Trauma (Trauma)
CL Item
Suicide (Suicide)
CL Item
Liver failure (Liver failure)
CL Item
Renal failure (Renal failure)
CL Item
Sepsis (Sepsis)
CL Item
Multiorgan failure (Multiorgan failure)
CL Item
Other (Other)
Event tracking number
Item
Event tracking number
text
C0441471 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Supportive data
Item
Any other supportive data
boolean
C1320722 (UMLS CUI [1])
Event tracking number
Item
Event tracking number
text
C0441471 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Event text
Item
Event text
text
C1527021 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,2])
Event started date and time
Item
Event started date and time
datetime
C2585732 (UMLS CUI [1,1])
C0151744 (UMLS CUI [1,2])
C0151744 (UMLS CUI [1,2])
CL Item
≥10-<20 mins (≥10-<20 mins)
CL Item
≥20 mins (≥20 mins)
Ischaemic symptoms at rest
Item
Ischaemic symptoms at rest
boolean
C0745417 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
C0443144 (UMLS CUI [1,2])
Related to a procedure/ surgery
Item
Related to a procedure/surgery
boolean
C2924519 (UMLS CUI [1])
Urgent cardiac revascularization
Item
Event resulted in an urgent revascularization
boolean
C0027056 (UMLS CUI [1,1])
C0439609 (UMLS CUI [1,2])
C0439609 (UMLS CUI [1,2])
Item
Specify main reason urgent revascularization not performed
text
C0027056 (UMLS CUI [1,1])
C0439609 (UMLS CUI [1,2])
C0445106 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0439609 (UMLS CUI [1,2])
C0445106 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Code List
Specify main reason urgent revascularization not performed
CL Item
Subject refusal (Subject refusal)
CL Item
No significant coronary lesion (No significant coronary lesion)
CL Item
Vascular anatomy not suitable (Vascular anatomy not suitable)
CL Item
Subject’s condition not suitable (Subject’s condition not suitable)
CL Item
PCI planned within 30 days (PCI planned within 30 days)
CL Item
PCI planned after 30 days (PCI planned after 30 days)
CL Item
CABG planned within 30 days (CABG planned within 30 days)
CL Item
CABG planned after 30 days (CABG planned after 30 days)
CL Item
Other (Other)
Event prolonged an ongoing hospitalization
Item
Event prolonged an ongoing hospitalization
boolean
C0745041 (UMLS CUI [1])
Event resulted in a hospitalization
Item
Event resulted in a hospitalization
boolean
C0019993 (UMLS CUI [1])
Event did not result in or prolong an ongoing hospitalization
Item
Event did not result in or prolong an ongoing hospitalization
boolean
C1519255 (UMLS CUI [1,1])
C3640791 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
C3640791 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
Q waves
Item
New Q waves (> 0.03 sec in width and > 1 mm in depth)
boolean
C1305738 (UMLS CUI [1])
ST depression
Item
New ST depression (> 0.5 mm)
boolean
C0520887 (UMLS CUI [1])
T wave inversion
Item
New pathological T wave inversion (> 1 mm)
boolean
C0520888 (UMLS CUI [1])
ST elevation
Item
New ST elevation (> 1 mm)
boolean
C0520886 (UMLS CUI [1])
left bundle branch block
Item
New left bundle branch block
boolean
C0023211 (UMLS CUI [1])
Cardiac biomarker measurements
Item
Local cardiac biomarker measurements
text
C1271630 (UMLS CUI [1])
Death
Item
Did this event result in death
boolean
C1306577 (UMLS CUI [1])
CL Item
STEMI (STEMI)
I (UMLS CUI-1)
CL Item
NSTEMI (NSTEMI)
I (UMLS CUI-1)
CL Item
Unstable angina (Unstable angina)
I (UMLS CUI-1)
CL Item
Stable angina (Stable angina)
I (UMLS CUI-1)
CL Item
Other (Other)
I (UMLS CUI-1)
Additional cardiac ischaemic events
Item
Did the Subject experience any additional cardiac ischaemic events since previous visit
boolean
C0151744 (UMLS CUI [1])
Event tracking number
Item
Event tracking number
text
C0877248 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Event text
Item
Event text
text
C1527021 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Event started date and time
Item
Event started date and time
date
C2585732 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,2])
CL Item
Stroke (Stroke)
C0038454 (UMLS CUI-1)
CL Item
TIA (TIA)
C0007787 (UMLS CUI-1)
Item
Symptoms of stroke/TIA
text
C1457887 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,2])
CL Item
Hemiplegia/paresis (Hemiplegia/paresis)
CL Item
Hemianaesthesia/sensory deficit (Hemianaesthesia/sensory deficit)
CL Item
Hemianopsia (Hemianopsia)
CL Item
Neglect (Neglect)
CL Item
Isolated facial weakness/droop (Isolated facial weakness/droop)
CL Item
Ataxia/dysmetria (Ataxia/dysmetria)
CL Item
Dysarthria/speech impairment (Dysarthria/speech impairment)
CL Item
Aphasia (expressive and/or (Aphasia (expressive and/or)
CL Item
receptive (receptive)
CL Item
Other (Other)
CL Item
<24 hrs (1)
I (UMLS CUI-1)
CL Item
>24 hrs (2)
I (UMLS CUI-1)
CL Item
Persistent (3)
I (UMLS CUI-1)
hospitalization prolonged
Item
Event prolonged an ongoing hospitalization
boolean
C0745041 (UMLS CUI [1])
Hospitalization
Item
Event resulted in a hospitalization
boolean
C0019993 (UMLS CUI [1])
Event did not result in or prolong an ongoing hospitalization
Item
Event did not result in or prolong an ongoing hospitalization
boolean
C0745041 (UMLS CUI [1])
Item
Stroke/TIA verified by
text
C1711411 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,2])
CL Item
Autopsy (Autopsy)
I (UMLS CUI-1)
CL Item
Clinical diagnosis (Clinical diagnosis)
I (UMLS CUI-1)
CL Item
CT scan (CT scan)
I (UMLS CUI-1)
CL Item
MRI (MRI)
I (UMLS CUI-1)
CL Item
Lumbar puncture (Lumbar puncture)
I (UMLS CUI-1)
CL Item
Neurosurgery (Neurosurgery)
I (UMLS CUI-1)
CL Item
Other (Other)
I (UMLS CUI-1)
Event tracking number
Item
Event tracking number
text
C0877248 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Event text
Item
Event text
text
C1527021 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
Major bleed, fatal/life-threatening (Major bleed, fatal/life-threatening)
C3160769 (UMLS CUI-1)
CL Item
Major bleed, other (Major bleed, other)
C3160769 (UMLS CUI-1)
CL Item
Minor bleed (Minor bleed)
C3160770 (UMLS CUI-1)
CL Item
Minimal bleed (Minimal bleed)
N (UMLS CUI-1)
Item
Primary location of bleed
text
C0019080 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
CL Item
Subcutaneous/dermal (Subcutaneous/dermal)
I (UMLS CUI-1)
CL Item
Cardiac cath/PCI access site (Cardiac cath/PCI access site)
I (UMLS CUI-1)
CL Item
Epistaxis (Epistaxis)
I (UMLS CUI-1)
CL Item
Gastrointestinal (Gastrointestinal)
I (UMLS CUI-1)
CL Item
Urinary (Urinary)
I (UMLS CUI-1)
CL Item
Retroperitoneal (Retroperitoneal)
I (UMLS CUI-1)
CL Item
Pericardial (Pericardial)
I (UMLS CUI-1)
CL Item
Intracranial (Intracranial)
I (UMLS CUI-1)
CL Item
Hemoptysis (Hemoptysis)
I (UMLS CUI-1)
CL Item
Intraocular (Intraocular)
I (UMLS CUI-1)
CL Item
Intraspinal (Intraspinal)
I (UMLS CUI-1)
CL Item
Intra-articular (Intra-articular)
I (UMLS CUI-1)
CL Item
Other bleeding site (Other bleeding site)
I (UMLS CUI-1)
CL Item
Spontaneous bleed (Spontaneous bleed)
C1321132 (UMLS CUI-1)
CL Item
Related to procedure (Related to procedure)
C0032788 (UMLS CUI-1)
Administration of pressors
Item
Administration of pressors
boolean
C0237795 (UMLS CUI [1])
Haemodynamic compromise
Item
Haemodynamic compromise
boolean
C0948268 (UMLS CUI [1])
Surgical intervention required to stop or treat bleeding
Item
Surgical intervention required to stop or treat bleeding
boolean
C0149533 (UMLS CUI [1])
Haemoglobin measurements
Item
Haemoglobin measurements relevant to event
text
C0518015 (UMLS CUI [1])
Haemoglobin measurements not available preceding event
Item
Haemoglobin measurements not available preceding event
boolean
C0149533 (UMLS CUI [1])
Event tracking number
Item
Event tracking number
text
C0877248 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Event text
Item
Event text
text
C1527021 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Event started date and time
Item
Event started date and time
datetime
C2585732 (UMLS CUI [1,1])
C0151942 (UMLS CUI [1,2])
C0151942 (UMLS CUI [1,2])
CL Item
Abrupt development of pain in an extremity (Abrupt development of pain in an extremity)
I (UMLS CUI-1)
CL Item
Abrupt development of flank pain (Abrupt development of flank pain)
I (UMLS CUI-1)
CL Item
Abrupt development of abdominal pain (Abrupt development of abdominal pain)
I (UMLS CUI-1)
CL Item
Absent pulses, pallor, and/or paresis (Absent pulses, pallor, and/or paresis)
I (UMLS CUI-1)
CL Item
in an extremity (at least an entire digit) (in an extremity (at least an entire digit))
I (UMLS CUI-1)
CL Item
Change in laboratory values (Change in laboratory values)
I (UMLS CUI-1)
CL Item
Abrupt loss in vision (Abrupt loss in vision)
I (UMLS CUI-1)
CL Item
Other (Other)
I (UMLS CUI-1)
CL Item
Angiography (Angiography)
I (UMLS CUI-1)
CL Item
CT scan (CT scan)
I (UMLS CUI-1)
CL Item
MRI (MRI)
I (UMLS CUI-1)
CL Item
Ultrasound (Ultrasound)
I (UMLS CUI-1)
CL Item
Colonoscopy (Colonoscopy)
I (UMLS CUI-1)
CL Item
Other (Other)
I (UMLS CUI-1)
hospitalization prolonged
Item
Event prolonged an ongoing hospitalization
boolean
C0745041 (UMLS CUI [1])
Hospitalization
Item
Event resulted in a hospitalization
boolean
C0019993 (UMLS CUI [1])
Event did not result in or prolong an ongoing hospitalization
Item
Event did not result in or prolong an ongoing hospitalization
boolean
C0745041 (UMLS CUI [1])
CL Item
Renal infarction (Renal infarction)
I (UMLS CUI-1)
CL Item
Retinal infarction (Retinal infarction)
I (UMLS CUI-1)
CL Item
Bowel infarction (Bowel infarction)
I (UMLS CUI-1)
CL Item
Peripheral ischaemia (Peripheral ischaemia)
I (UMLS CUI-1)
CL Item
Other (Other)
I (UMLS CUI-1)