ID

42241

Description

The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI). https://clinicaltrials.gov/ct2/show/NCT01015287

Link

https://clinicaltrials.gov/ct2/show/NCT01015287

Keywords

  1. 7/28/15 7/28/15 -
  2. 4/14/21 4/14/21 - Ahmed Rafee, MD
  3. 4/14/21 4/14/21 - Ahmed Rafee, MD
Copyright Holder

folgt

Uploaded on

April 14, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility ACCOAST Acute Coronary Syndrome NCT01015287

Eligibility criteria

  1. StudyEvent: ODM
    1. Eligibility criteria
Inclusion Criteria
Description

Inclusion Criteria

Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
Description

Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin

Data type

boolean

Alias
UMLS CUI-1
C0948089
Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
Description

Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin

Data type

boolean

Alias
UMLS CUI-1
C3537184
Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
Description

Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin

Data type

boolean

Alias
UMLS CUI-1
C0523952
Scheduled for coronary angiography greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization
Description

Scheduled for coronary angiography greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization

Data type

boolean

Alias
UMLS CUI-1
C0085532
Scheduled for coronary PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization
Description

Scheduled for coronary PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization

Data type

boolean

Alias
UMLS CUI-1
C1532338
Must be eligible for treatment with prasugrel
Description

Must be eligible for treatment with prasugrel

Data type

boolean

Alias
UMLS CUI-1
C1620287
Must be eligible for treatment with aspirin (ASA)
Description

Must be eligible for treatment with aspirin (ASA)

Data type

boolean

Alias
UMLS CUI-1
C0004057
Must be eligible for treatment with a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor
Description

Must be eligible for treatment with a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor

Data type

text

Alias
UMLS CUI-1
C3640054
May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel
Description

May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel

Data type

boolean

Alias
UMLS CUI-1
C0070166
Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital
Description

Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital

Data type

boolean

Alias
UMLS CUI [1,1]
C0019994
UMLS CUI [1,2]
C0018795
Exclusion Criteria
Description

Exclusion Criteria

Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization
Description

Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization

Data type

boolean

Alias
UMLS CUI-1
C1536220
Have cardiogenic shock
Description

Have cardiogenic shock

Data type

boolean

Alias
UMLS CUI-1
C0036980
Have refractory ventricular arrhythmias
Description

Have refractory ventricular arrhythmias

Data type

boolean

Alias
UMLS CUI-1
C0085612
Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)
Description

Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)

Data type

text

Alias
UMLS CUI-1
C1319796
UMLS CUI-2
C0018802
Have had cardiac arrest within 1 week of entry or randomization into the study
Description

Have had cardiac arrest within 1 week of entry or randomization into the study

Data type

boolean

Alias
UMLS CUI-1
C0018790

Similar models

Eligibility criteria

  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Acute coronary syndrome
Item
Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
boolean
C0948089 (UMLS CUI-1)
NSTEMI
Item
Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
boolean
C3537184 (UMLS CUI-1)
Troponin
Item
Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
boolean
C0523952 (UMLS CUI-1)
Coronary angiography
Item
Scheduled for coronary angiography greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization
boolean
C0085532 (UMLS CUI-1)
PCI
Item
Scheduled for coronary PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization
boolean
C1532338 (UMLS CUI-1)
Prasugrel
Item
Must be eligible for treatment with prasugrel
boolean
C1620287 (UMLS CUI-1)
Aspirin
Item
Must be eligible for treatment with aspirin (ASA)
boolean
C0004057 (UMLS CUI-1)
GP IIb/IIIa antagonist
Item
Must be eligible for treatment with a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor
text
C3640054 (UMLS CUI-1)
Clopidogrel
Item
May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel
boolean
C0070166 (UMLS CUI-1)
Cardiac catheterization laboratory
Item
Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital
boolean
C0019994 (UMLS CUI [1,1])
C0018795 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
STEMI
Item
Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization
boolean
C1536220 (UMLS CUI-1)
Cardiogenic shock
Item
Have cardiogenic shock
boolean
C0036980 (UMLS CUI-1)
Ventricular arrhythmia
Item
Have refractory ventricular arrhythmias
boolean
C0085612 (UMLS CUI-1)
Congestive heart failure
Item
Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)
text
C1319796 (UMLS CUI-1)
C0018802 (UMLS CUI-2)
Cardiac arrest
Item
Have had cardiac arrest within 1 week of entry or randomization into the study
boolean
C0018790 (UMLS CUI-1)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial