ID

11703

Beschreibung

This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization). https://clinicaltrials.gov/ct2/show/NCT00699998

Link

https://clinicaltrials.gov/ct2/show/NCT00699998

Stichworte

Versionen (1)
  1. 28.07.15 28.07.15 -
Hochgeladen am

28. Juli 2015

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility TRILOGY ACS Acute Coronary Syndrome NCT00699998

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Key Inclusion Criteria
Beschreibung

Key Inclusion Criteria

Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
Beschreibung

Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization

Datentyp

boolean

Alias
UMLS CUI-1
C0002965
Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
Beschreibung

Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization

Datentyp

boolean

Alias
UMLS CUI-1
C3537184
Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
Beschreibung

Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event

Datentyp

boolean

Alias
UMLS CUI-1
C1532338
Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
Beschreibung

Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event

Datentyp

boolean

Alias
UMLS CUI-1
C0010055
Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event
Beschreibung

Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

Datentyp

boolean

Alias
UMLS CUI-1
C2024776
Key Exclusion Criteria
Beschreibung

Key Exclusion Criteria

ST-segment elevation myocardial infarction (STEMI) as the index event
Beschreibung

ST-segment elevation myocardial infarction (STEMI) as the index event

Datentyp

boolean

Alias
UMLS CUI-1
C1536220
Cardiogenic shock
Beschreibung

Cardiogenic shock

Datentyp

boolean

Alias
UMLS CUI-1
C0036980
Refractory ventricular arrhythmias
Beschreibung

Refractory ventricular arrhythmias

Datentyp

boolean

Alias
UMLS CUI-1
C0085612
New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours
Beschreibung

New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours

Datentyp

boolean

Alias
UMLS CUI-1
C0018802
History of ischemic or hemorrhagic stroke
Beschreibung

History of ischemic or hemorrhagic stroke

Datentyp

boolean

Alias
UMLS CUI-1
C0559159
History of transient ischemic attack (TIA)
Beschreibung

History of transient ischemic attack (TIA)

Datentyp

boolean

Alias
UMLS CUI-1
C0455536
History of Intracranial neoplasm
Beschreibung

History of Intracranial neoplasm

Datentyp

boolean

Alias
UMLS CUI-1
C1527390
arteriovenous malformation
Beschreibung

arteriovenous malformation

Datentyp

boolean

Alias
UMLS CUI-1
C0003857
aneurysm
Beschreibung

aneurysm

Datentyp

boolean

Alias
UMLS CUI-1
C0002940
History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence
Beschreibung

History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence

Datentyp

boolean

Alias
UMLS CUI-1
C0019080
Hemodialysis or peritoneal dialysis
Beschreibung

Hemodialysis or peritoneal dialysis

Datentyp

boolean

Alias
UMLS CUI-1
C0019004
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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Key Inclusion Criteria
Unstable angina
Item
Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
boolean
C0002965 (UMLS CUI-1)
NSTEMI
Item
Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
boolean
C3537184 (UMLS CUI-1)
PCI
Item
Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
boolean
C1532338 (UMLS CUI-1)
CABG
Item
Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
boolean
C0010055 (UMLS CUI-1)
Cardiac risk factors
Item
Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event
boolean
C2024776 (UMLS CUI-1)
Item Group
Key Exclusion Criteria
STEMI
Item
ST-segment elevation myocardial infarction (STEMI) as the index event
boolean
C1536220 (UMLS CUI-1)
Cardiogenic shock
Item
Cardiogenic shock
boolean
C0036980 (UMLS CUI-1)
Ventricular arrhythmias
Item
Refractory ventricular arrhythmias
boolean
C0085612 (UMLS CUI-1)
Congestive heart failure
Item
New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours
boolean
C0018802 (UMLS CUI-1)
History of stroke
Item
History of ischemic or hemorrhagic stroke
boolean
C0559159 (UMLS CUI-1)
History of TIA
Item
History of transient ischemic attack (TIA)
boolean
C0455536 (UMLS CUI-1)
Intracranial neoplasm
Item
History of 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)
Hemorrhage
Item
History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence
boolean
C0019080 (UMLS CUI-1)
Hemodialysis
Item
Hemodialysis or peritoneal dialysis
boolean
C0019004 (UMLS CUI-1)
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