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View Clinical Trial (Medical Research Study)

A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects - NCT00699998-Ede - 00259 (Clinical Trial 227189)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy227189.aspx



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City:  Ede
Country:  
Netherlands
Conditions: Acute Coronary Syndrome
Purpose: This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed UA/NSTEMI ACS population (that is, patients who are not managed with acute coronary revascularization).
Study summary: Based upon the significant number of subjects with UA/NSTEMI ACS who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. Potential subjects will be those with a recent UA/NSTEMI event who are to be medically managed. Eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. The TRILOGY ACS study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed UA/NSTEMI ACS subjects.
Criteria: Key Inclusion Criteria: - Have had a UA/NSTEMI index event within 10 days prior to randomization - Had a medical management strategy decision made with reasonable certainty that neither PCI nor CABG is planned for treatment of the index event - Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event Key Exclusion Criteria: - Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event. - Insignificant CAD on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel) - Previous or planned PCI or CABG as treatment for the index event - PCI/CABG within previous 30 days - STEMI as the index event - Cardiogenic shock, Refractory ventricular arrhythmias, NYHA Class IV CHF within the previous 24 hours - History of ischemic or hemorrhagic stroke, TIA, Intracranial neoplasm, arteriovenous malformation, or aneurysm - History of spontaneous GI or non-GI bleeding requiring hospitalization for treatment, unless definitive Rx has occurred and there is low likelihood of recurrence - Hemodialysis or peritoneal dialysis
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: September 12, 2009
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