ID

12455

Description

The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke. (https://clinicaltrials.gov/ct2/show/NCT00097591)

Link

https://clinicaltrials.gov/ct2/show/NCT00097591

Keywords

Versions (2)
  1. 7/28/15 7/28/15 -
  2. 11/20/15 11/20/15 -
Uploaded on

November 20, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Comparison of Prasugrel and Clopidogrel Acute Coronary Syndrome NCT00097591

English

Eligiblity Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligiblity Criteria
Inclusion Criteria
Description

Inclusion Criteria

A person who has been diagnosed with acute coronary syndrome
Description

A person who has been diagnosed with acute coronary syndrome

Data type

boolean

Alias
UMLS CUI-1
C0948089
A person who is to undergo a percutaneous coronary intervention.
Description

A person who is to undergo a percutaneous coronary intervention.

Data type

boolean

Alias
UMLS CUI-1
C1532338
A person who is of the legal age of 18
Description

A person who is of the legal age of 18

Data type

boolean

Alias
UMLS CUI-1
C0001779
A person who is mentally competent to provide a signed written informed consent.
Description

A person who is mentally competent to provide a signed written informed consent.

Data type

boolean

Alias
UMLS CUI-1
C0021430
If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy
Description

If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy

Data type

boolean

Alias
UMLS CUI-1
C0549206
If a woman is of childbearing potential (i.e., before menopause), she must agree to use a reliable method of birth control.
Description

If a woman is of childbearing potential (i.e., before menopause), she must agree to use a reliable method of birth control.

Data type

boolean

Alias
UMLS CUI-1
C0700589
Exclusion Criteria
Description

Exclusion Criteria

A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.
Description

A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.

Data type

boolean

Alias
UMLS CUI-1
C0559159
A person who has active internal bleeding or has a history of a bleeding disorder.
Description

A person who has active internal bleeding or has a history of a bleeding disorder.

Data type

boolean

Alias
UMLS CUI-1
C0019080
Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.
Description

Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.

Data type

boolean

Alias
UMLS CUI-1
C3251812
A person who has liver disease; for example, cirrhosis.
Description

A person who has liver disease; for example, cirrhosis.

Data type

boolean

Alias
UMLS CUI-1
C0085605
A person who has a condition such as alcoholism
Description

A person who has a condition such as alcoholism

Data type

boolean

Alias
UMLS CUI [1]
C0038586
mental illness
Description

mental illness

Data type

boolean

Alias
UMLS CUI-1
C0004936
drug dependent
Description

drug dependent

Data type

boolean

Alias
UMLS CUI-1
C1510472
A person who has cardiogenic shock
Description

A person who has cardiogenic shock

Data type

boolean

Alias
UMLS CUI-1
C0036980
refractory ventricular arrhythmia
Description

refractory ventricular arrhythmia

Data type

boolean

Alias
UMLS CUI-1
C0085612
congestive heart failure (class IV)
Description

congestive heart failure (class IV)

Data type

boolean

Alias
UMLS CUI-1
C0018801
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Similar models

Eligiblity Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligiblity Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Acute coronary syndrome
Item
A person who has been diagnosed with acute coronary syndrome
boolean
C0948089 (UMLS CUI-1)
PCI
Item
A person who is to undergo a percutaneous coronary intervention.
boolean
C1532338 (UMLS CUI-1)
Age
Item
A person who is of the legal age of 18
boolean
C0001779 (UMLS CUI-1)
Informed consent
Item
A person who is mentally competent to provide a signed written informed consent.
boolean
C0021430 (UMLS CUI-1)
Pregnancy
Item
If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy
boolean
C0549206 (UMLS CUI-1)
Contraception
Item
If a woman is of childbearing potential (i.e., before menopause), she must agree to use a reliable method of birth control.
boolean
C0700589 (UMLS CUI-1)
Item Group
Exclusion Criteria
History of stroke
Item
A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.
boolean
C0559159 (UMLS CUI-1)
Hemorrhage
Item
A person who has active internal bleeding or has a history of a bleeding disorder.
boolean
C0019080 (UMLS CUI-1)
Bleeding risk
Item
Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.
boolean
C3251812 (UMLS CUI-1)
Liver failure
Item
A person who has liver disease; for example, cirrhosis.
boolean
C0085605 (UMLS CUI-1)
Alcoholism
Item
A person who has a condition such as alcoholism
boolean
C0038586 (UMLS CUI [1])
mental disorder
Item
mental illness
boolean
C0004936 (UMLS CUI-1)
drug dependence
Item
drug dependent
boolean
C1510472 (UMLS CUI-1)
Cardiogenic shock
Item
A person who has cardiogenic shock
boolean
C0036980 (UMLS CUI-1)
Ventricular arrhythmia
Item
refractory ventricular arrhythmia
boolean
C0085612 (UMLS CUI-1)
Heart failure
Item
congestive heart failure (class IV)
boolean
C0018801 (UMLS CUI-1)
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