ID
11711
Descripción
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
Palabras clave
Versiones (1)
- 28/7/15 28/7/15 -
Subido en
28 de julio de 2015
DOI
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Licencia
Creative Commons BY 4.0
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Eligibility Clopidogrel to Prasugrel Acute Coronary Syndrome NCT01115738
Eligibility Criteria
- StudyEvent: ODM
Descripción
Exclusion Criteria
Descripción
Have cardiogenic shock at the time of randomization
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0036980
Descripción
Have refractory ventricular arrhythmias
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0085612
Descripción
Have New York Heart Association (NYHA) Class IV congestive heart failure
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0018802
Descripción
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 datos
boolean
Alias
- UMLS CUI-1
- C0871470
Descripción
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 datos
boolean
Alias
- UMLS CUI-1
- C0428883
Descripción
Have received fibrin-specific fibrinolytic therapy less than 24 hours prior to randomization
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0040044
Descripción
Have active internal bleeding or history of bleeding diathesis
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0019080
Descripción
Have clinical findings associated with an increased risk of bleeding
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C3251812
Descripción
Prior history of ischemic or hemorrhagic stroke
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0559159
Descripción
Intracranial neoplasm
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C1527390
Descripción
arteriovenous malformation
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0003857
Descripción
aneurysm
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0002940
Descripción
Prior history of transient ischemic attack (TIA)
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0455536
Descripción
Have an International Normalized Ratio (INR) known to be greater than 1.5 at the time of evaluation
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0525032
Descripción
Have a platelet count of less than 100,000 per cubic millimeter (mm^3) at the time of evaluation
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0032181
Descripción
Have anemia [hemoglobin (Hgb) less than 10 grams per deciliter (g/dL)] at the time of evaluation
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0002871
Descripción
Have received 1 or more doses of a thienopyridine or other adenosine diphosphate (ADP) receptor inhibitor within 10 days prior to screening
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C2936588
Descripción
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 datos
boolean
Alias
- UMLS CUI-1
- C3640054
Descripción
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 datos
boolean
Alias
- UMLS CUI-1
- C0354604
Descripción
Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued during the study
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0003211
Descripción
Are women who are known to be pregnant
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0549206
Descripción
Breastfeeding
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0006147
Descripción
Have known severe hepatic dysfunction (that is, with cirrhosis or portal hypertension)
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0085605
Descripción
Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine, clopidogrel or prasugrel)
Tipo de datos
boolean
Alias
- UMLS CUI-1
- C0004058
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Eligibility Criteria
- StudyEvent: ODM