ID

12473

Description

This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel. https://clinicaltrials.gov/ct2/show/NCT00385944

Link

https://clinicaltrials.gov/ct2/show/NCT00385944

Keywords

Versions (2)
  1. 28/07/15 28/07/15 -
  2. 21/11/15 21/11/15 -
Uploaded on

21 novembre 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Prasugrel vs Clopidogrel Acute Coronary Syndrome NCT00385944

English

Eligiblity Criteria

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

Inclusion Criteria

Present with acute coronary syndrome (ACS)
Description

Present with acute coronary syndrome (ACS)

Data type

boolean

Alias
UMLS CUI-1
C0948089
Have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel
Description

Have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel

Data type

boolean

Alias
UMLS CUI-1
C0070166
Are between the ages of 18 and 85 years.
Description

Are between the ages of 18 and 85 years.

Data type

boolean

Alias
UMLS CUI-1
C0001779
Willing and able to sign informed consent.
Description

Willing and able to sign informed consent.

Data type

boolean

Alias
UMLS CUI-1
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Have overt ST-segment elevation myocardial infarction (STEMI).
Description

Have overt ST-segment elevation myocardial infarction (STEMI).

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.
Description

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

Data type

boolean

Alias
UMLS CUI-1
C0018801
Have severe and uncontrolled hypertension.
Description

Have severe and uncontrolled hypertension.

Data type

boolean

Alias
UMLS CUI-1
C0020538
Have active internal bleeding or history of bleeding diathesis.
Description

Have active internal bleeding or history of bleeding diathesis.

Data type

boolean

Alias
UMLS CUI-1
C0019080
Have an increased risk of bleeding.
Description

Have an increased risk of bleeding.

Data type

boolean

Alias
UMLS CUI-1
C3251812
Have history of cerebrovascular accidents.
Description

Have history of cerebrovascular accidents.

Data type

boolean

Alias
UMLS CUI-1
C0559159
Have certain abnormal blood level values.
Description

Have certain abnormal blood level values.

Data type

boolean

Alias
UMLS CUI [1]
C0438258
Are currently receiving chemotherapy
Description

Are currently receiving chemotherapy

Data type

boolean

Alias
UMLS CUI-1
C3665472
Are currently receiving radiation therapy.
Description

Are currently receiving radiation therapy.

Data type

boolean

Alias
UMLS CUI-1
C1522449
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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
Present with acute coronary syndrome (ACS)
boolean
C0948089 (UMLS CUI-1)
Clopidogrel
Item
Have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel
boolean
C0070166 (UMLS CUI-1)
Age
Item
Are between the ages of 18 and 85 years.
boolean
C0001779 (UMLS CUI-1)
Informed consent
Item
Willing and able to sign informed consent.
boolean
C0021430 (UMLS CUI-1)
Item Group
Exclusion Criteria
STEMI
Item
Have overt ST-segment elevation myocardial infarction (STEMI).
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)
Heart failure
Item
Have New York Heart Association (NYHA) Class IV congestive heart failure.
boolean
C0018801 (UMLS CUI-1)
Hypertension
Item
Have severe and uncontrolled hypertension.
boolean
C0020538 (UMLS CUI-1)
Hemorrhage
Item
Have active internal bleeding or history of bleeding diathesis.
boolean
C0019080 (UMLS CUI-1)
Bleeding risk
Item
Have an increased risk of bleeding.
boolean
C3251812 (UMLS CUI-1)
History of stroke
Item
Have history of cerebrovascular accidents.
boolean
C0559159 (UMLS CUI-1)
Abnormal blood level values
Item
Have certain abnormal blood level values.
boolean
C0438258 (UMLS CUI [1])
Chemotherapy
Item
Are currently receiving chemotherapy
boolean
C3665472 (UMLS CUI-1)
Radiation therapy
Item
Are currently receiving radiation therapy.
boolean
C1522449 (UMLS CUI-1)
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