Clinical Studies

Effient Was Studied in TRITON-TIMI 38, a Head-to-Head Trial

The objective of the TRITON-TIMI 38 clinical trial was to evaluate the efficacy and safety of Effient^® (prasugrel) plus aspirin (ASA) compared with Plavix^® (clopidogrel bisulfate) plus ASA in patients with ACS managed with PCI.^1,2

*Secondary efficacy endpoints included the primary composite endpoint at 30 and 90 days; composite of the rate of death from CV causes, nonfatal myocardial infarction (MI), or urgent target-vessel revascularization (UTVR) at 30 and 90 days; composite of the rate of death from CV causes, nonfatal MI, nonfatal stroke, or rehospitalization due to a cardiac ischemic event; stent thrombosis; and all-cause death, nonfatal MI, or nonfatal stroke. ^†Intracranial hemorrhage or clinically overt bleeding associated with a fall in hemoglobin ≥5 g/dL. ^‡Clinically overt bleeding associated with a fall in hemoglobin of ≥3 g/dL but <5 g/dL.

Additional trial information

• In TRITON-TIMI 38, the loading dose of Plavix was delayed relative to the placebo-controlled trials that supported its approval for ACS²
• 74% were UA/NSTEMI patients (n=10,074) and approximately one-fourth (26%) were STEMI patients (n =3534)^1,2
• The TRITON-TIMI 38 trial was not designed to evaluate a correlation between platelet inhibition and clinical outcomes^1,2

Treatment considerations²

• Effient plus ASA and Plavix plus ASA were not administered to UA/NSTEMI patients until coronary anatomy was established in the TRITON-TIMI 38 clinical trial. Because the large majority of patients are managed without CABG, treatment can be considered before determining the coronary anatomy if the need for CABG is considered unlikely
  • For the small fraction of patients who required urgent CABG after treatment with Effient, the risk of significant bleeding was substantial. The advantages of earlier treatment with Effient must be balanced against the increased rate of bleeding in patients who need to undergo urgent CABG