ID

11734

Beskrivning

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.

Nyckelord

  1. 2015-07-28 2015-07-28 -
  2. 2015-11-21 2015-11-21 -
Uppladdad den

28 juli 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Eligibility Criteria: The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)

Eligiblity Criteria

  1. StudyEvent: ODM
    1. Eligiblity Criteria
Inclusion Criteria
Beskrivning

Inclusion Criteria

Present with acute coronary syndrome (ACS)
Beskrivning

Present with acute coronary syndrome (ACS)

Datatyp

boolean

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

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

Datatyp

boolean

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

Are between the ages of 18 and 85 years.

Datatyp

boolean

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

Willing and able to sign informed consent.

Datatyp

boolean

Alias
UMLS CUI-1
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

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

Datatyp

boolean

Alias
UMLS CUI-1
C1536220
Have cardiogenic shock.
Beskrivning

Have cardiogenic shock.

Datatyp

boolean

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

Have refractory ventricular arrhythmias.

Datatyp

boolean

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

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

Datatyp

boolean

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

Have severe and uncontrolled hypertension.

Datatyp

boolean

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

Have active internal bleeding or history of bleeding diathesis.

Datatyp

boolean

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

Have an increased risk of bleeding.

Datatyp

boolean

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

Have history of cerebrovascular accidents.

Datatyp

boolean

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

Have certain abnormal blood level values.

Datatyp

boolean

Alias
UMLS CUI-1
N
Are currently receiving chemotherapy
Beskrivning

Are currently receiving chemotherapy

Datatyp

boolean

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

Are currently receiving radiation therapy.

Datatyp

boolean

Alias
UMLS CUI-1
C1522449

Similar models

Eligiblity Criteria

  1. StudyEvent: ODM
    1. Eligiblity Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
N (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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