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: |
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Ede |
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Country:
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Netherlands |
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| Conditions: |
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Acute Coronary Syndrome |
| Purpose: |
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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).
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| Study summary: |
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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: |
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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 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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September 12, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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