TROPICAL-ACS (Testing responsiveness to platelet inhibition on chronic antiplatelet treatment for acute coronary syndromes) is a new investigator-initiated multicentre study designed to evaluate the benefit of personalised antiplatelet therapy in patients who have acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI).
A Roche press release reports that the primary purpose of the study is to evaluate whether a treatment approach guided by platelet function testing with Roche’s Multiplate1 analyser is non-inferior to a 12-month standard therapy with prasugrel. The study will involve 2,600 patients from 15 investigational centres in Europe.
The press release adds that TROPICAL-ACS is the first large evaluation conducted to assess the benefits of tailored antiplatelet treatment in ACS patients with combined ischaemic and bleeding events. Enrolment of patients is expected to be completed in mid-2015 with a subsequent 12-month period to conclude the entire follow-up.
“The innovative design of the TROPICAL-ACS trial focuses on a high risk ACS patient cohort, provides potent drug intervention for clopidogrel low responders, and uses a biomarker that is able to accurately identify patients at increased thrombotic risk. Most of the benefit for potent platelet inhibition with prasugrel over conventional clopidogrel treatment in ACS patients was seen in the early and acute phase of treatment; however, in the long term high levels of platelet inhibition may even be harmful due to the increased bleeding risk,” stated Dirk Sibbing, principal investigator and cardiologist at the Department of Cardiology at Ludwig-Maximilians University Hospital in Munich, Germany. “In the past, we have seen some negative results with the GRAVITAS and ARCTIC clinical trials, but we also have promising experiences from studies with Multiplate in clinical routine. These favour an individualised treatment approach.”
According to the press release, a tailored antiplatelet approach may trigger significant cost savings while maintaining the clinical benefit for patients—without exposing them to a potentially elevated risk of bleeding.