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TRILOGY-ACS TRIAL |
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| Problem | UA/NSTEMI no for revasc. |
| Format | Randomized, double-blind, double-dummy, active-control, event-driven trial |
| Treatment | Prasugrel |
| Control | Clopidogrel |
| Population | 9326 patients |
| Inclusion criteria | UA/NSTEMI with medical management without revascularization within 10 days after the index event. -NSTEMI patients had elevated cardiac markers, whereas patients with unstable angina with negative cardiac markers had an ST-segment depression of more than 1 mm in two or more electrocardiographic leads At least one of four risk criteria: 1) An age of at least 60 years 2) The presence of diabetes mellitus 3) Previous myocardial infarction 4) Previous revascularization with either PCI or coronary-artery bypass grafting (CABG). Angiography was not required for enrollment, but if such a procedure was planned, it had to be performed before randomization. Patients who underwent angiography were required to have evidence of coronary disease (native coronary stenosis of >30% or previous PCI or CABG) |
| Exclusion criteria | History of transient ischemic attack or stroke, PCI or CABG within the previous 30 days Renal failure requiring dialysis Concomitant treatment with an oral anticoagulant |
| Follow-up | Median 17.1 months |
| Primary endpoint | Composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke among patients under the age of 75 years |
| Secondary endpoint(s) | First occurrence of: cardiovascular death or MI Cardiovascular death, MI, stroke, or rehospitalization for recurrent UA All-cause death, MI, or stroke Stent thrombosis Although TRILOGY ACS will enroll medically managed patients, rates of stent thrombosis will be examined per regulatory requirements because it is anticipated that some subjects will have undergone previous coronary stenting before the index ACS event or may undergo coronary stenting during study follow-up for a recurrent ischemic event. |
| Details | Patients who underwent randomization within 72 hours after the first medical contact without previous clopidogrel treatment received a loading dose of 30 mg of prasugrel or 300 mg of clopidogrel, which was followed by daily blinded maintenance administration of a study drug. The prasugrel maintenance dose was 10 mg, which was adjusted to 5 mg for patients who were 75 years of age or older or who weighed less than 60 kg. The clopidogrel maintenance dose was 75 mg for all patients. Pharmacokinetic modeling from previous trials showed that 5 mg of prasugrel in patients weighing less than 60 kg resulted in an antiplatelet effect that was similar to that for 10 mg in heavier patients. The 5-mg dose that was used in participants 75 years of age or older had not been evaluated in previous outcomes trials. |
| Brief summary: | No improvement in mortality for prasugrel vs. clopidogrel in UA/NSTEMI if no PCI |
| PAPER: Prasugrel versus Clopidogrel for Acute Coronary Syndromes without Revascularization. | |
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| Date | 25 Aug 2012 |
| Journal | N Engl J Med. 2012 Aug 25. [Epub ahead of print] |
| Information | Prasugrel vs. clopidogrel (loadining & maintenance) in UA/NSTEMI not for revasc -No difference at 17mo in death from cardiovascular causes/myocardial infarction/stroke -Suggested reduction in multiple recurrent ischaemic events (HR 0.85; p=0.04) -No difference in severe, major, or life-threatening bleeding -Higher rates of minor or moderate bleeding -Higher frequency of heart failure in the clopidogrel group |