ID

11711

Descrição

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

Palavras-chave

Versões (1)
  1. 28/07/2015 28/07/2015 -
Transferido a

28 de julho de 2015

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Clopidogrel to Prasugrel Acute Coronary Syndrome NCT01115738

Inglês

Eligibility Criteria

1 Formulários  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Descrição

Inclusion Criteria

Participants hospitalized with acute coronary syndrome (ACS)
Descrição

Participants hospitalized with acute coronary syndrome (ACS)

Tipo de dados

boolean

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

anticipated to undergo percutaneous coronary intervention (PCI)

Tipo de dados

boolean

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

Participants provide signed informed consent form (ICF)

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

Alias
UMLS CUI-1
C0549206
Exclusion Criteria
Descrição

Exclusion Criteria

Have cardiogenic shock at the time of randomization
Descrição

Have cardiogenic shock at the time of randomization

Tipo de dados

boolean

Alias
UMLS CUI-1
C0036980
Have refractory ventricular arrhythmias
Descrição

Have refractory ventricular arrhythmias

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

Have active internal bleeding or history of bleeding diathesis

Tipo de dados

boolean

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

Have clinical findings associated with an increased risk of bleeding

Tipo de dados

boolean

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

Prior history of ischemic or hemorrhagic stroke

Tipo de dados

boolean

Alias
UMLS CUI-1
C0559159
Intracranial neoplasm
Descrição

Intracranial neoplasm

Tipo de dados

boolean

Alias
UMLS CUI-1
C1527390
arteriovenous malformation
Descrição

arteriovenous malformation

Tipo de dados

boolean

Alias
UMLS CUI-1
C0003857
aneurysm
Descrição

aneurysm

Tipo de dados

boolean

Alias
UMLS CUI-1
C0002940
Prior history of transient ischemic attack (TIA)
Descrição

Prior history of transient ischemic attack (TIA)

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

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.
Descrição

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.

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

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

Are women who are known to be pregnant

Tipo de dados

boolean

Alias
UMLS CUI-1
C0549206
Breastfeeding
Descrição

Breastfeeding

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

Alias
UMLS CUI-1
C0004058
Voltar ao início da página

Similar models

Eligibility Criteria

1 Formulários
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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)
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial