ID

11711

Beschreibung

This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on platelet inhibition in patients presenting with acute coronary syndrome (ACS). Platelet inhibition following a prasugrel LD in clopidogrel pretreated patients' will be determined in a time-dependent manner for two different prasugrel loading doses (30 mg and 60 mg). Understanding the effects of this combination on platelet inhibition will provide guidance to physicians on the use of prasugrel in patients who have already been pretreated with clopidogrel. https://clinicaltrials.gov/ct2/show/NCT01115738

Link

https://clinicaltrials.gov/ct2/show/NCT01115738

Stichworte

Versionen (1)
  1. 28.07.15 28.07.15 -
Hochgeladen am

28. Juli 2015

DOI

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Creative Commons BY 4.0
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Eligibility Clopidogrel to Prasugrel Acute Coronary Syndrome NCT01115738

Englisch

Eligibility Criteria

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

Inclusion Criteria

Participants hospitalized with acute coronary syndrome (ACS)
Beschreibung

Participants hospitalized with acute coronary syndrome (ACS)

Datentyp

boolean

Alias
UMLS CUI-1
C0948089
anticipated to undergo percutaneous coronary intervention (PCI)
Beschreibung

anticipated to undergo percutaneous coronary intervention (PCI)

Datentyp

boolean

Alias
UMLS CUI-1
C1532338
Participants provide signed informed consent form (ICF)
Beschreibung

Participants provide signed informed consent form (ICF)

Datentyp

boolean

Alias
UMLS CUI-1
C0021430
Participants weigh at least 60 kilograms (kg) at the time of screening
Beschreibung

Participants weigh at least 60 kilograms (kg) at the time of screening

Datentyp

boolean

Alias
UMLS CUI-1
C0005910
test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test
Beschreibung

test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test

Datentyp

boolean

Alias
UMLS CUI-1
C0549206
Exclusion Criteria
Beschreibung

Exclusion Criteria

Have cardiogenic shock at the time of randomization
Beschreibung

Have cardiogenic shock at the time of randomization

Datentyp

boolean

Alias
UMLS CUI-1
C0036980
Have refractory ventricular arrhythmias
Beschreibung

Have refractory ventricular arrhythmias

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI-1
C0018802
Have systolic blood pressure greater than 180 mm Hg, or diastolic blood pressure greater than 100 mm Hg on more than 1 assessment at any time from participant presentation of ACS treatment to enrollment
Beschreibung

Have systolic blood pressure greater than 180 mm Hg, or diastolic blood pressure greater than 100 mm Hg on more than 1 assessment at any time from participant presentation of ACS treatment to enrollment

Datentyp

boolean

Alias
UMLS CUI-1
C0871470
Have systolic blood pressure greater than 180 mm Hg, or diastolic blood pressure greater than 100 mm Hg on more than 1 assessment at any time from participant presentation of ACS treatment to enrollment
Beschreibung

Have systolic blood pressure greater than 180 mm Hg, or diastolic blood pressure greater than 100 mm Hg on more than 1 assessment at any time from participant presentation of ACS treatment to enrollment

Datentyp

boolean

Alias
UMLS CUI-1
C0428883
Have received fibrin-specific fibrinolytic therapy less than 24 hours prior to randomization
Beschreibung

Have received fibrin-specific fibrinolytic therapy less than 24 hours prior to randomization

Datentyp

boolean

Alias
UMLS CUI-1
C0040044
Have active internal bleeding or history of bleeding diathesis
Beschreibung

Have active internal bleeding or history of bleeding diathesis

Datentyp

boolean

Alias
UMLS CUI-1
C0019080
Have clinical findings associated with an increased risk of bleeding
Beschreibung

Have clinical findings associated with an increased risk of bleeding

Datentyp

boolean

Alias
UMLS CUI-1
C3251812
Prior history of ischemic or hemorrhagic stroke
Beschreibung

Prior history of ischemic or hemorrhagic stroke

Datentyp

boolean

Alias
UMLS CUI-1
C0559159
Intracranial neoplasm
Beschreibung

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
Prior history of transient ischemic attack (TIA)
Beschreibung

Prior history of transient ischemic attack (TIA)

Datentyp

boolean

Alias
UMLS CUI-1
C0455536
Have an International Normalized Ratio (INR) known to be greater than 1.5 at the time of evaluation
Beschreibung

Have an International Normalized Ratio (INR) known to be greater than 1.5 at the time of evaluation

Datentyp

boolean

Alias
UMLS CUI-1
C0525032
Have a platelet count of less than 100,000 per cubic millimeter (mm^3) at the time of evaluation
Beschreibung

Have a platelet count of less than 100,000 per cubic millimeter (mm^3) at the time of evaluation

Datentyp

boolean

Alias
UMLS CUI-1
C0032181
Have anemia [hemoglobin (Hgb) less than 10 grams per deciliter (g/dL)] at the time of evaluation
Beschreibung

Have anemia [hemoglobin (Hgb) less than 10 grams per deciliter (g/dL)] at the time of evaluation

Datentyp

boolean

Alias
UMLS CUI-1
C0002871
Have received 1 or more doses of a thienopyridine or other adenosine diphosphate (ADP) receptor inhibitor within 10 days prior to screening
Beschreibung

Have received 1 or more doses of a thienopyridine or other adenosine diphosphate (ADP) receptor inhibitor within 10 days prior to screening

Datentyp

boolean

Alias
UMLS CUI-1
C2936588
Have been administered glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitor within the past 7 days or planned use of a GPIIb/IIIa inhibitor during PCI
Beschreibung

Have been administered glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitor within the past 7 days or planned use of a GPIIb/IIIa inhibitor during PCI

Datentyp

boolean

Alias
UMLS CUI-1
C3640054
Are receiving or will receive oral anticoagulation or other antiplatelet therapy, other than aspirin (ASA), which cannot be safely discontinued for the duration of the study.
Beschreibung

Are receiving or will receive oral anticoagulation or other antiplatelet therapy, other than aspirin (ASA), which cannot be safely discontinued for the duration of the study.

Datentyp

boolean

Alias
UMLS CUI-1
C0354604
Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued during the study
Beschreibung

Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued during the study

Datentyp

boolean

Alias
UMLS CUI-1
C0003211
Are women who are known to be pregnant
Beschreibung

Are women who are known to be pregnant

Datentyp

boolean

Alias
UMLS CUI-1
C0549206
Breastfeeding
Beschreibung

Breastfeeding

Datentyp

boolean

Alias
UMLS CUI-1
C0006147
Have known severe hepatic dysfunction (that is, with cirrhosis or portal hypertension)
Beschreibung

Have known severe hepatic dysfunction (that is, with cirrhosis or portal hypertension)

Datentyp

boolean

Alias
UMLS CUI-1
C0085605
Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine, clopidogrel or prasugrel)
Beschreibung

Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine, clopidogrel or prasugrel)

Datentyp

boolean

Alias
UMLS CUI-1
C0004058
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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
Inclusion Criteria
Acute coronary syndrome
Item
Participants hospitalized with acute coronary syndrome (ACS)
boolean
C0948089 (UMLS CUI-1)
PCI
Item
anticipated to undergo percutaneous coronary intervention (PCI)
boolean
C1532338 (UMLS CUI-1)
Informed consent
Item
Participants provide signed informed consent form (ICF)
boolean
C0021430 (UMLS CUI-1)
Weight
Item
Participants weigh at least 60 kilograms (kg) at the time of screening
boolean
C0005910 (UMLS CUI-1)
Pregnancy
Item
test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test
boolean
C0549206 (UMLS CUI-1)
Item Group
Exclusion Criteria
Cardiogenic shock
Item
Have cardiogenic shock at the time of randomization
boolean
C0036980 (UMLS CUI-1)
Ventricular arrhythmia
Item
Have refractory ventricular arrhythmias
boolean
C0085612 (UMLS CUI-1)
Congestive heart failure
Item
Have New York Heart Association (NYHA) Class IV congestive heart failure
boolean
C0018802 (UMLS CUI-1)
Systolic blood pressure
Item
Have systolic blood pressure greater than 180 mm Hg, or diastolic blood pressure greater than 100 mm Hg on more than 1 assessment at any time from participant presentation of ACS treatment to enrollment
boolean
C0871470 (UMLS CUI-1)
Diastolic blood pressure
Item
Have systolic blood pressure greater than 180 mm Hg, or diastolic blood pressure greater than 100 mm Hg on more than 1 assessment at any time from participant presentation of ACS treatment to enrollment
boolean
C0428883 (UMLS CUI-1)
Thrombolytic therapy
Item
Have received fibrin-specific fibrinolytic therapy less than 24 hours prior to randomization
boolean
C0040044 (UMLS CUI-1)
Hemorrhage
Item
Have active internal bleeding or history of bleeding diathesis
boolean
C0019080 (UMLS CUI-1)
Bleeding risk
Item
Have clinical findings associated with an increased risk of bleeding
boolean
C3251812 (UMLS CUI-1)
History of stroke
Item
Prior 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
Prior history of transient ischemic attack (TIA)
boolean
C0455536 (UMLS CUI-1)
INR
Item
Have an International Normalized Ratio (INR) known to be greater than 1.5 at the time of evaluation
boolean
C0525032 (UMLS CUI-1)
Platelet count
Item
Have a platelet count of less than 100,000 per cubic millimeter (mm^3) at the time of evaluation
boolean
C0032181 (UMLS CUI-1)
Anemia
Item
Have anemia [hemoglobin (Hgb) less than 10 grams per deciliter (g/dL)] at the time of evaluation
boolean
C0002871 (UMLS CUI-1)
Thienopyridines
Item
Have received 1 or more doses of a thienopyridine or other adenosine diphosphate (ADP) receptor inhibitor within 10 days prior to screening
boolean
C2936588 (UMLS CUI-1)
GPIIb/IIIa antagonist
Item
Have been administered glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitor within the past 7 days or planned use of a GPIIb/IIIa inhibitor during PCI
boolean
C3640054 (UMLS CUI-1)
Oral anticoagulants
Item
Are receiving or will receive oral anticoagulation or other antiplatelet therapy, other than aspirin (ASA), which cannot be safely discontinued for the duration of the study.
boolean
C0354604 (UMLS CUI-1)
NSAID
Item
Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued during the study
boolean
C0003211 (UMLS CUI-1)
Pregnancy
Item
Are women who are known to be pregnant
boolean
C0549206 (UMLS CUI-1)
Breastfeeding
Item
Breastfeeding
boolean
C0006147 (UMLS CUI-1)
Liver failure
Item
Have known severe hepatic dysfunction (that is, with cirrhosis or portal hypertension)
boolean
C0085605 (UMLS CUI-1)
Aspirin allergy
Item
Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine, clopidogrel or prasugrel)
boolean
C0004058 (UMLS CUI-1)
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