ID

11700

Description

The study will compare the safety and efficacy of prasugrel, administered at different doses with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention.

Keywords

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

July 28, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility Criteria: A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome

English

Eligibiltiy Critera

1 forms  
  1. StudyEvent: ODM
    1. Eligibiltiy Critera
Inclusion Criteria
Description

Inclusion Criteria

A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI)
Description

A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI)

Data type

boolean

Alias
UMLS CUI-1
C0948089
A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI)
Description

A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI)

Data type

boolean

Alias
UMLS CUI-1
C1532338
A person who is of East or Southeast Asian descent
Description

A person who is of East or Southeast Asian descent

Data type

boolean

Alias
UMLS CUI-1
C0078988
A person who is of the legal age of 18 (or age 21 in Singapore)
Description

A person who is of the legal age of 18 (or age 21 in Singapore)

Data type

boolean

Alias
UMLS CUI-1
C0001779
Is mentally competent to provide a signed written informed consent before entering the study
Description

Is mentally competent to provide a signed written informed consent before entering the study

Data type

boolean

Alias
UMLS CUI-1
C0021430
If a woman is of childbearing potential, she must test negative for pregnancy
Description

If a woman is of childbearing potential, she must test negative for pregnancy

Data type

boolean

Alias
UMLS CUI-1
C0549206
agree to use a reliable method of birth control
Description

agree to use a reliable method of birth control

Data type

boolean

Alias
UMLS CUI-1
C0700589
Exclusion Criteria
Description

Exclusion Criteria

cardiogenic shock
Description

cardiogenic shock

Data type

boolean

Alias
UMLS CUI-1
C0036980
ventricular arrhythmias
Description

ventricular arrhythmias

Data type

boolean

Alias
UMLS CUI-1
C0085612
congestive heart failure
Description

congestive heart failure

Data type

boolean

Alias
UMLS CUI-1
C0018802
A person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study)
Description

A person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study)

Data type

boolean

Alias
UMLS CUI-1
C3251812
History of ischemic or hemorrhagic stroke
Description

History of ischemic or hemorrhagic stroke

Data type

boolean

Alias
UMLS CUI-1
C0559159
intracranial neoplasm
Description

intracranial neoplasm

Data type

boolean

Alias
UMLS CUI-1
C1527390
arteriovenous malformation
Description

arteriovenous malformation

Data type

boolean

Alias
UMLS CUI-1
C0003857
aneurysm
Description

aneurysm

Data type

boolean

prior history of transient ischemic attack (TIA)
Description

prior history of transient ischemic attack (TIA)

Data type

boolean

Alias
UMLS CUI-1
C0455536
A person who needs to take other antiplatelet therapy other than Aspirin for the duration of the study
Description

A person who needs to take other antiplatelet therapy other than Aspirin for the duration of the study

Data type

boolean

Alias
UMLS CUI-1
C1096021
A person who receives daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued
Description

A person who receives daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued

Data type

boolean

Alias
UMLS CUI-1
C0003211
A person who has a severe liver disease, such as cirrhosis
Description

A person who has a severe liver disease, such as cirrhosis

Data type

boolean

Alias
UMLS CUI-1
C0085605
Alcoholism
Description

Alcoholism

Data type

boolean

Alias
UMLS CUI-1
C0455500
mental illness
Description

mental illness

Data type

boolean

Alias
UMLS CUI-1
C0004936
drug dependence
Description

drug dependence

Data type

boolean

Alias
UMLS CUI-1
C1510472
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Similar models

Eligibiltiy Critera

1 forms
  1. StudyEvent: ODM
    1. Eligibiltiy Critera
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 (ACS) and is to undergo a percutaneous coronary intervention (PCI)
boolean
C0948089 (UMLS CUI-1)
PCI
Item
A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI)
boolean
C1532338 (UMLS CUI-1)
Asian
Item
A person who is of East or Southeast Asian descent
boolean
C0078988 (UMLS CUI-1)
Age
Item
A person who is of the legal age of 18 (or age 21 in Singapore)
boolean
C0001779 (UMLS CUI-1)
Informed consent
Item
Is mentally competent to provide a signed written informed consent before entering the study
boolean
C0021430 (UMLS CUI-1)
Pregnancy
Item
If a woman is of childbearing potential, she must test negative for pregnancy
boolean
C0549206 (UMLS CUI-1)
Birth control
Item
agree to use a reliable method of birth control
boolean
C0700589 (UMLS CUI-1)
Item Group
Exclusion Criteria
cardiogenic shock
Item
cardiogenic shock
boolean
C0036980 (UMLS CUI-1)
ventricular arrhythmia
Item
ventricular arrhythmias
boolean
C0085612 (UMLS CUI-1)
congestive heart failure
Item
congestive heart failure
boolean
C0018802 (UMLS CUI-1)
Bleeding risk
Item
A person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study)
boolean
C3251812 (UMLS CUI-1)
History of stroke
Item
History of ischemic or hemorrhagic stroke
boolean
C0559159 (UMLS CUI-1)
intracranial neoplasm
Item
intracranial neoplasm
boolean
C1527390 (UMLS CUI-1)
arteriovenous malformation
Item
arteriovenous malformation
boolean
C0003857 (UMLS CUI-1)
aneurysm
Item
aneurysm
boolean
History of TIA
Item
prior history of transient ischemic attack (TIA)
boolean
C0455536 (UMLS CUI-1)
antiplatelet therapy
Item
A person who needs to take other antiplatelet therapy other than Aspirin for the duration of the study
boolean
C1096021 (UMLS CUI-1)
NSAID
Item
A person who receives daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued
boolean
C0003211 (UMLS CUI-1)
liver failure
Item
A person who has a severe liver disease, such as cirrhosis
boolean
C0085605 (UMLS CUI-1)
Alcoholism
Item
Alcoholism
boolean
C0455500 (UMLS CUI-1)
mental disorders
Item
mental illness
boolean
C0004936 (UMLS CUI-1)
drug dependence
Item
drug dependence
boolean
C1510472 (UMLS CUI-1)
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