ID
11711
Beschrijving
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
Trefwoorden
Versies (1)
- 28-07-15 28-07-15 -
Geüploaded op
28 juli 2015
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Clopidogrel to Prasugrel Acute Coronary Syndrome NCT01115738
Eligibility Criteria
- StudyEvent: ODM
Beschrijving
Exclusion Criteria
Beschrijving
Have cardiogenic shock at the time of randomization
Datatype
boolean
Alias
- UMLS CUI-1
- C0036980
Beschrijving
Have refractory ventricular arrhythmias
Datatype
boolean
Alias
- UMLS CUI-1
- C0085612
Beschrijving
Have New York Heart Association (NYHA) Class IV congestive heart failure
Datatype
boolean
Alias
- UMLS CUI-1
- C0018802
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI-1
- C0871470
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI-1
- C0428883
Beschrijving
Have received fibrin-specific fibrinolytic therapy less than 24 hours prior to randomization
Datatype
boolean
Alias
- UMLS CUI-1
- C0040044
Beschrijving
Have active internal bleeding or history of bleeding diathesis
Datatype
boolean
Alias
- UMLS CUI-1
- C0019080
Beschrijving
Have clinical findings associated with an increased risk of bleeding
Datatype
boolean
Alias
- UMLS CUI-1
- C3251812
Beschrijving
Prior history of ischemic or hemorrhagic stroke
Datatype
boolean
Alias
- UMLS CUI-1
- C0559159
Beschrijving
Intracranial neoplasm
Datatype
boolean
Alias
- UMLS CUI-1
- C1527390
Beschrijving
arteriovenous malformation
Datatype
boolean
Alias
- UMLS CUI-1
- C0003857
Beschrijving
aneurysm
Datatype
boolean
Alias
- UMLS CUI-1
- C0002940
Beschrijving
Prior history of transient ischemic attack (TIA)
Datatype
boolean
Alias
- UMLS CUI-1
- C0455536
Beschrijving
Have an International Normalized Ratio (INR) known to be greater than 1.5 at the time of evaluation
Datatype
boolean
Alias
- UMLS CUI-1
- C0525032
Beschrijving
Have a platelet count of less than 100,000 per cubic millimeter (mm^3) at the time of evaluation
Datatype
boolean
Alias
- UMLS CUI-1
- C0032181
Beschrijving
Have anemia [hemoglobin (Hgb) less than 10 grams per deciliter (g/dL)] at the time of evaluation
Datatype
boolean
Alias
- UMLS CUI-1
- C0002871
Beschrijving
Have received 1 or more doses of a thienopyridine or other adenosine diphosphate (ADP) receptor inhibitor within 10 days prior to screening
Datatype
boolean
Alias
- UMLS CUI-1
- C2936588
Beschrijving
Have been administered glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitor within the past 7 days or planned use of a GPIIb/IIIa inhibitor during PCI
Datatype
boolean
Alias
- UMLS CUI-1
- C3640054
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI-1
- C0354604
Beschrijving
Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued during the study
Datatype
boolean
Alias
- UMLS CUI-1
- C0003211
Beschrijving
Are women who are known to be pregnant
Datatype
boolean
Alias
- UMLS CUI-1
- C0549206
Beschrijving
Breastfeeding
Datatype
boolean
Alias
- UMLS CUI-1
- C0006147
Beschrijving
Have known severe hepatic dysfunction (that is, with cirrhosis or portal hypertension)
Datatype
boolean
Alias
- UMLS CUI-1
- C0085605
Beschrijving
Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine, clopidogrel or prasugrel)
Datatype
boolean
Alias
- UMLS CUI-1
- C0004058
Similar models
Eligibility Criteria
- StudyEvent: ODM