ID
11711
Beskrivning
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
Länk
https://clinicaltrials.gov/ct2/show/NCT01115738
Nyckelord
Versioner (1)
- 2015-07-28 2015-07-28 -
Uppladdad den
28 juli 2015
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Clopidogrel to Prasugrel Acute Coronary Syndrome NCT01115738
Eligibility Criteria
- StudyEvent: ODM
Beskrivning
Exclusion Criteria
Beskrivning
Have cardiogenic shock at the time of randomization
Datatyp
boolean
Alias
- UMLS CUI-1
- C0036980
Beskrivning
Have refractory ventricular arrhythmias
Datatyp
boolean
Alias
- UMLS CUI-1
- C0085612
Beskrivning
Have New York Heart Association (NYHA) Class IV congestive heart failure
Datatyp
boolean
Alias
- UMLS CUI-1
- C0018802
Beskrivning
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
Datatyp
boolean
Alias
- UMLS CUI-1
- C0871470
Beskrivning
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
Datatyp
boolean
Alias
- UMLS CUI-1
- C0428883
Beskrivning
Have received fibrin-specific fibrinolytic therapy less than 24 hours prior to randomization
Datatyp
boolean
Alias
- UMLS CUI-1
- C0040044
Beskrivning
Have active internal bleeding or history of bleeding diathesis
Datatyp
boolean
Alias
- UMLS CUI-1
- C0019080
Beskrivning
Have clinical findings associated with an increased risk of bleeding
Datatyp
boolean
Alias
- UMLS CUI-1
- C3251812
Beskrivning
Prior history of ischemic or hemorrhagic stroke
Datatyp
boolean
Alias
- UMLS CUI-1
- C0559159
Beskrivning
Intracranial neoplasm
Datatyp
boolean
Alias
- UMLS CUI-1
- C1527390
Beskrivning
arteriovenous malformation
Datatyp
boolean
Alias
- UMLS CUI-1
- C0003857
Beskrivning
aneurysm
Datatyp
boolean
Alias
- UMLS CUI-1
- C0002940
Beskrivning
Prior history of transient ischemic attack (TIA)
Datatyp
boolean
Alias
- UMLS CUI-1
- C0455536
Beskrivning
Have an International Normalized Ratio (INR) known to be greater than 1.5 at the time of evaluation
Datatyp
boolean
Alias
- UMLS CUI-1
- C0525032
Beskrivning
Have a platelet count of less than 100,000 per cubic millimeter (mm^3) at the time of evaluation
Datatyp
boolean
Alias
- UMLS CUI-1
- C0032181
Beskrivning
Have anemia [hemoglobin (Hgb) less than 10 grams per deciliter (g/dL)] at the time of evaluation
Datatyp
boolean
Alias
- UMLS CUI-1
- C0002871
Beskrivning
Have received 1 or more doses of a thienopyridine or other adenosine diphosphate (ADP) receptor inhibitor within 10 days prior to screening
Datatyp
boolean
Alias
- UMLS CUI-1
- C2936588
Beskrivning
Have been administered glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitor within the past 7 days or planned use of a GPIIb/IIIa inhibitor during PCI
Datatyp
boolean
Alias
- UMLS CUI-1
- C3640054
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI-1
- C0354604
Beskrivning
Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued during the study
Datatyp
boolean
Alias
- UMLS CUI-1
- C0003211
Beskrivning
Are women who are known to be pregnant
Datatyp
boolean
Alias
- UMLS CUI-1
- C0549206
Beskrivning
Breastfeeding
Datatyp
boolean
Alias
- UMLS CUI-1
- C0006147
Beskrivning
Have known severe hepatic dysfunction (that is, with cirrhosis or portal hypertension)
Datatyp
boolean
Alias
- UMLS CUI-1
- C0085605
Beskrivning
Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine, clopidogrel or prasugrel)
Datatyp
boolean
Alias
- UMLS CUI-1
- C0004058
Similar models
Eligibility Criteria
- StudyEvent: ODM