Start of the TROPICAL-ACS large intervention study on Multiplate®-guided anti-platelet therapy in ACS patients
Rotkreuz/Switzerland, 04 September 2013
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the start of the TROPICAL-ACS (Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet treatment for Acute Coronary Syndromes) trial, an investigator-initiated multicenter study designed to evaluate the benefit of personalized antiplatelet therapy in patients who have acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI). The trial's primary purpose is to evaluate whether a treatment approach guided by platelet function testing with Roche’s Multiplate1 analyzer is non-inferior to a 12-month standard therapy with prasugrel. The study will involve 2600 patients from 15 investigational centers in Europe.
TROPICAL-ACS is a prospective, randomized, parallel-group, open-label, non-inferiority trial and will be the first large evaluation conducted to assess the benefits of tailored anti-platelet treatment in ACS patients with combined ischemic and bleeding events. Enrollment 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, MD, 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 favor an individualized treatment approach.”
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.
Prof. Christian Zaugg, Global Medical Leader at Roche Professional Diagnostics, states: “Our support for this investigator-initiated study reinforces Roche’s strong commitment to Personalized Healthcare. Tailoring anti-platelet therapy to the patients’ needs could support the cost-effective decision-making of healthcare professionals to improve the benefits and safety of platelet inhibiting drugs. This in turn drives Roche’s ambition to bring medical value to the patient.”
About TROPICAL-ACS trial
Platelet inhibitors such as Aspirin® and clopidogrel are commonly used to ensure blood fluidity and to minimize the risk of arterial thrombus formation. However, not all ACS patients adequately respond to anti thrombotic agents: Up to 25% respond insufficiently to a treatment with clopidogrel after PCI, exhibiting high residual on-treatment reactivity (HPR).2 Patients with HPR have been shown to be at increased risk of stent thrombosis, myocardial infarction and stroke.
Prasugrel is a new generation ADP receptor antagonist that has shown its superiority compared to clopidogrel in terms of thrombotic risk reduction. However, it comes at a substantially higher cost than the generic clopidogrel and is accompanied by increased exposure for bleeding, including life threatening bleeding3, predominantly during the long-term treatment4.
The trial’s design randomizes the 2600 patients under investigation into two groups: While one group will continue receiving standard treatment with prasugrel over the course of 12 months, a second group will receive short-term prasugrel in the first week after PCI, followed by a treatment with clopidogrel in the second week. Individuals with an adequate response will continue on clopidogrel therapy for another 11.5 months, whereas patients with high on-clopidogrel platelet reactivity will switch to an 11.5–month course of treatment with prasugrel.
The TROPICAL-ACS Steering Committee comprises a group of internationally recognized physicians in the field of cardiology and includes Prof. Steffen Massberg, MD, Prof. Julinda Mehilli, MD, Prof. Jörg Hausleiter, MD, Dr. Dirk Sibbing, MD, all from the Department of Cardiology at the Ludwig-Maximilians University in Munich, Germany; Prof. Franz-Josef Neumann, MD, University Heart Center in Bad Krozingen, Germany; Prof. Kurt Huber, MD, Wilhelminen Hospital in Vienna, Austria; Dr. Daniel Arádi, MD, State Heart Center in Balatonfüred, Hungary.
Results of prior studies provide evidence that Multiplate aids healthcare professionals in predicting thrombotic5,6,7 and bleeding risk8,9 in patients undergoing coronary stenting. A consensus document by the Working Group on High Platelet Reactivity10 acknowledged the high predictive value of Multiplate, and three recently published registry studies with more than 2000 patients confirm Multiplate’s utility for routine guidance of antiplatelet treatment in patients undergoing coronary stenting11-13.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
1)Available worldwide but in the U.S. for research use only
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12) Aradi, D. et al. (2013). J Am Coll Cardiol; 61(10), Suppl. E1922
13) Mayer K. et al. (2013). ESC congress; P4872
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