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