TRILOGY-ACS TRIAL

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.