ID

12473

Descripción

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

Palabras clave

Versiones (2)
  1. 28/7/15 28/7/15 -
  2. 21/11/15 21/11/15 -
Subido en

21 de noviembre de 2015

DOI

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Licencia

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

Inglés

Eligiblity Criteria

1 formularios  
  1. StudyEvent: ODM
    1. Eligiblity Criteria
Inclusion Criteria
Descripción

Inclusion Criteria

Present with acute coronary syndrome (ACS)
Descripción

Present with acute coronary syndrome (ACS)

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

Are between the ages of 18 and 85 years.

Tipo de datos

boolean

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

Willing and able to sign informed consent.

Tipo de datos

boolean

Alias
UMLS CUI-1
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

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

Tipo de datos

boolean

Alias
UMLS CUI-1
C1536220
Have cardiogenic shock.
Descripción

Have cardiogenic shock.

Tipo de datos

boolean

Alias
UMLS CUI-1
C0036980
Have refractory ventricular arrhythmias.
Descripción

Have refractory ventricular arrhythmias.

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

Have severe and uncontrolled hypertension.

Tipo de datos

boolean

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

Have active internal bleeding or history of bleeding diathesis.

Tipo de datos

boolean

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

Have an increased risk of bleeding.

Tipo de datos

boolean

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

Have history of cerebrovascular accidents.

Tipo de datos

boolean

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

Have certain abnormal blood level values.

Tipo de datos

boolean

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

Are currently receiving chemotherapy

Tipo de datos

boolean

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

Are currently receiving radiation therapy.

Tipo de datos

boolean

Alias
UMLS CUI-1
C1522449
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Similar models

Eligiblity Criteria

1 formularios
  1. StudyEvent: ODM
    1. Eligiblity Criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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