None listed
Conditions
Interventions
Group 1 Type of group
Three Prasugrel 10 mg tablets and four placebo tablets identical to clopidogrel as loading dose. Maintenance dose: One tablet of Prasugrel 10 mg or one tablet of 5 mg and one placebo tablet identical to clopidogrel QD until the end of the study.
Group name:Group 2 Type of group
Four tablets of Clopidogrel 75 mg and three placebo tablets identical to prasugrel as loading dose. Maintenance dose: One tablet of Clopidogrel 75 mg and one placebo tablet identical to prasugrel QD Until the end of the study.
Sponsors
ELI LILLY AND COMPANY,
Eligibility
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Have had a UA / NSTEMI index event within 7 days (168 hours) before randomization (based on the diagnostic criteria for the disease included in Section 4.1.1). • Have made a decision about the medical treatment strategy with reasonable certainty; that is, neither a PCI nor a CABG is planned for the treatment of the index event. • Have had at least 1 of the following 3 characteristics that indicate high risk at the time of the UA / NSTEMI event: Age> 60 years, previous MI that is evidenced by pre-existing Q waves, or demonstration of infarction in the studies of imaging detection, or previous documentation of elevated cardiac markers, Diabetes mellitus, defined according to concomitant treatment with an oral hypoglycaemic agent and / or insulin. • Have at least 1 stenosis in native coronary arteries> 50% (applies only to those subjects who undergo diagnostic coronary angiography within a period of 7 days from the start of the index event, but who do not undergo a PCI or a CABG after the angiography was performed).
Exclusion criteria
Exclusion criteria: • Medical treatment decision> 24 hours after the start of the index event without treatment with commercial clopidogrel within 24 hours after the start of the index event (note: treatment with commercial clopidogrel should continue on a daily basis, hereinafter, until randomization). • PCI or CABG previous or planned (during index hospitalization or hereafter) as treatment for the index event. • PCI or CABG within the previous 30 days. • STEMI as the index event. • Cardiogenic shock within the previous 24 hours (defined as systolic blood pressure 1.5 at the time of selection. • Platelet count 2 weeks with NSAIDs or inhibitors is anticipated of C0X2 during the study. • Not be willing to give written informed consent or not have enough mental conditions to do so. • Personnel of the research center directly affiliated with the study or direct family of the personnel of the research center directly affiliated with the study. The spouse, parents, children or biological or legally adopted brothers are direct relatives. • Staff employed by Eli Lilly and Company, Ube Industries Limited, Daiichi Sankyo Pharma Inc, academic research organization (ARO), or contract research organization (CRO) (ie, employees, temporary contract workers or designated responsible persons) of the realization of the study). Direct family members of Lilly employees may participate in clinical studies sponsored by Lilly, but are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Cardiovascular death (CV death): Death due to a documented cardiovascular cause. Myocardial infarction (MI): depends on the clinical moment in which the event occurs in relation to the presentation of the syndrome and cardiovascular procedures. Stroke: The rapid onset of a new persistent neurological deficit lasting more than 24 hours. Measure:Time elapsed until the endpoint of cardiovascular death, Myocardial Infarction or stroke occurs for the first time. Timepoints:until the event occurs for the first time | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:ardiovascular death (CV death): Death due to a documented cardiovascular cause. Myocardial infarction (MI): depends on the clinical moment in which the event occurs in relation to the presentation of the syndrome and cardiovascular procedures. Measure:Time elapsed until the CV and MI death assessment criteria are produced for the first time. Timepoints:until the event occurs for the first time ; Outcome name:Cardiovascular death (CV death): Death due to a documented cardiovascular cause. Stroke: The rapid onset of a new persistent neurological deficit lasting more than 24 hours. Re-hospitalization for recurrent UA includes chest discomfort or equivalent ischemic symptoms of > 10 minutes duration at rest Measure:Time elapsed until the endpoint for CV death, MI, cerebrovascular accident or re-hospitalization due to recurrent UA occurs for the first time. Timepoints:until the event occurs for the first time ; Outcome name:Cardiovascular death (CV death): Death due to a documented cardiovascular cause. Myocardial infarction (MI): depends on the clinical moment in which the event occurs in relation to the presentation of the syndrome and cardiovascular procedures. Stroke: The rapid onset of a new persistent neurological deficit lasting more than 24 hours. Measure:Time elapsed until the endpoint for the first time, consisting of death from all causes, MI or stroke, occurs for the first time. Timepoints:until the event occurs for the first time | — |
Countries
Arabia Saudi, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Korea South, Lithuania, Malasya, MAlta, Mexico, Netherlands, New Zealand, Panama, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed