ID

11715

Description

This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS). https://clinicaltrials.gov/ct2/show/NCT00356135

Link

https://clinicaltrials.gov/ct2/show/NCT00356135

Keywords

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

July 28, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility SWAP Acute Coronary Syndrome NCT00356135

English

Eligibility Criteria

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

Inclusion Criteria

Present with a recent history of an ACS event
Description

Present with a recent history of an ACS event

Data type

boolean

Alias
UMLS CUI-1
C0948089
who state that they are supposed to be taking daily aspirin
Description

who state that they are supposed to be taking daily aspirin

Data type

boolean

Alias
UMLS CUI-1
C0004057
who state that they are supposed to be taking maintenance dose 75-mg clopidogrel.
Description

who state that they are supposed to be taking maintenance dose 75-mg clopidogrel.

Data type

boolean

Alias
UMLS CUI-1
C0070166
Are of a legal age (and at least 18 years of age but less than 75 years of age)
Description

Are of a legal age (and at least 18 years of age but less than 75 years of age)

Data type

boolean

Alias
UMLS CUI-1
C0001779
Are competent mental condition to provide written informed consent before entering the study.
Description

Are competent mental condition to provide written informed consent before entering the study.

Data type

boolean

Alias
UMLS CUI-1
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Left main coronary artery stent
Description

Left main coronary artery stent

Data type

boolean

Alias
UMLS CUI-1
N
left anterior descending (LAD) bifurcation stent
Description

left anterior descending (LAD) bifurcation stent

Data type

boolean

Alias
UMLS CUI-1
C3836455
Have any form of coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) planned to occur during the study (from signing consent through the final visit).
Description

Have any form of coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) planned to occur during the study (from signing consent through the final visit).

Data type

boolean

Alias
UMLS CUI-1
C1532338
Have any form of coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) planned to occur during the study (from signing consent through the final visit).
Description

Have any form of coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) planned to occur during the study (from signing consent through the final visit).

Data type

boolean

Alias
UMLS CUI-1
C0010055
Receiving or will receive oral anticoagulation (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study.
Description

Receiving or will receive oral anticoagulation (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study.

Data type

boolean

Alias
UMLS CUI-1
C0354604
Receiving or will receive other antiplatelet therapy (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study.
Description

Receiving or will receive other antiplatelet therapy (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study.

Data type

boolean

Alias
UMLS CUI-1
C1096021
Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or are anticipated to require daily treatment with NSAIDs during the study.
Description

Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or are anticipated to require daily treatment with NSAIDs during the study.

Data type

boolean

Alias
UMLS CUI-1
C0003211
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

Alias
UMLS CUI-1
C0002940
History of transient ischemic attack (TIA)
Description

History of transient ischemic attack (TIA)

Data type

boolean

Alias
UMLS CUI-1
C0455536
Have a body weight less than 60 kilograms (kg)
Description

Have a body weight less than 60 kilograms (kg)

Data type

boolean

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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Acute coronary syndrome
Item
Present with a recent history of an ACS event
boolean
C0948089 (UMLS CUI-1)
Aspirin
Item
who state that they are supposed to be taking daily aspirin
boolean
C0004057 (UMLS CUI-1)
Clopidogrel
Item
who state that they are supposed to be taking maintenance dose 75-mg clopidogrel.
boolean
C0070166 (UMLS CUI-1)
Age
Item
Are of a legal age (and at least 18 years of age but less than 75 years of age)
boolean
C0001779 (UMLS CUI-1)
Informed consent
Item
Are competent mental condition to provide written informed consent before entering the study.
boolean
C0021430 (UMLS CUI-1)
Item Group
Exclusion Criteria
Left main coronary artery stent
Item
Left main coronary artery stent
boolean
N (UMLS CUI-1)
left anterior descending (LAD) bifurcation stent
Item
left anterior descending (LAD) bifurcation stent
boolean
C3836455 (UMLS CUI-1)
PCI
Item
Have any form of coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) planned to occur during the study (from signing consent through the final visit).
boolean
C1532338 (UMLS CUI-1)
CABG
Item
Have any form of coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) planned to occur during the study (from signing consent through the final visit).
boolean
C0010055 (UMLS CUI-1)
Oral anticoagulants
Item
Receiving or will receive oral anticoagulation (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study.
boolean
C0354604 (UMLS CUI-1)
Antiplatelet therapy
Item
Receiving or will receive other antiplatelet therapy (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study.
boolean
C1096021 (UMLS CUI-1)
NSAID
Item
Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or are anticipated to require daily treatment with NSAIDs during the study.
boolean
C0003211 (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
C0002940 (UMLS CUI-1)
History of TIA
Item
History of transient ischemic attack (TIA)
boolean
C0455536 (UMLS CUI-1)
Weight
Item
Have a body weight less than 60 kilograms (kg)
boolean
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