News | September 06, 2012

TRILOGY ACS Shows Prasugrel Not Superior to Clopidogrel in Medically Managed Non-STEMI Patients Without Revascularization

Study does not meet primary objective of demonstrating prasugrel superiority over clopidogrel in patient population

September 6, 2012 — Daiichi Sankyo Co. Ltd. and Eli Lilly and Co. announced data from the TRILOGY ACS study, a phase III trial comparing prasugrel plus aspirin to clopidogrel plus aspirin in patients with unstable angina (UA) or non-ST elevation myocardial infarction (NSTEMI), who were managed medically without an artery-opening procedure.

At 30 months, 13.9 percent of prasugrel patients vs. 16 percent of clopidogrel patients experienced the combined primary endpoint of heart attack, stroke or cardiovascular (CV) death in patients less than 75 years of age, the primary analysis population (HR=0.91; 95 percent CI: 0.79-1.05). This outcome was not statistically significant (P=0.21). Different from other large-scale trials, TRILOGY ACS (TaRgeted platelet Inhibition to cLarify the Optimal strateGy to edicallY manage Acute Coronary Syndromes) prospectively studied only the UA/NSTEMI population medically managed without revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery). Results of this study were published in the New England Journal of Medicine and also presented during a late-breaking session at the European Society of Cardiology (ESC) Congress 2012 in Munich, Germany.

From a safety perspective, TRILOGY ACS showed that rates of TIMI major bleeding events (including life-threatening or fatal bleeds) did not differ significantly between the prasugrel plus aspirin and clopidogrel plus aspirin treatment groups in patients less than 75 years of age or in the overall study population. In patients under age 75, non-CABG TIMI major bleeding occurred in 2.1 percent of prasugrel patients versus 1.5 percent of clopidogrel patients (HR=1.31, 95 percent CI: 0.81-2.11, P=0.27). However, the rates of TIMI major or minor bleeding were higher in patients treated with prasugrel (3.3 percent of prasugrel patients versus 2.1 percent of clopidogrel patients; HR=1.54; 95 percent CI: 1.06-2.23; P=0.02).

"TRILOGY ACS was designed to evaluate dual oral antiplatelet therapy in UA/NSTEMI patients who are managed medically without revascularization," said E. Magnus Ohman, M.D., Duke Clinical Research Institute and Chairperson of the TRILOGY ACS trial. "While the study did not demonstrate prasugrel was superior to clopidogrel in these patients, TRILOGY ACS provided some additional observations in this previously understudied population. The delayed treatment effect beyond 12 months observed in TRILOGY ACS had not been seen in earlier studies of shorter duration." 

An analysis performed to account for multiple recurrent ischemic events suggested a lower risk among participants less than 75 years old treated with prasugrel (HR=0.85; 95 percent CI: 0.72–1.00; P=0.044).

A post-hoc exploratory analysis observed a trend for a lower risk in heart attack, stroke and death among patients treated with prasugrel beyond one year; HRs and 95 percent CIs for the time period of <12 months versus the time period of >12 months comparing prasugrel versus clopidogrel for the primary efficacy endpoint were 0.99 (0.84-1.16) versus 0.72 (0.54-0.97) (interaction P=0.07).

"Large-scale clinical trials in understudied populations, such as TRILOGY ACS, are important regardless of the result because they generate a sizeable amount of information for the medical community," said J. Anthony Ware, M.D., group vice president and cardiovascular/acute care platform leader, Eli Lilly and Co. "We look forward to presenting additional data from the platelet function sub-study, analyses of the elderly population data, as well as genomics information in future peer-reviewed forums." 

"While this is not the outcome we anticipated, we believe this study contributes to the knowledge base about ACS patients who are medically managed," said Glenn Gormley, M.D., Ph.D., global head of R&D and senior executive officer at Daiichi Sankyo Co. Ltd. "The group of patients in the TRILOGY ACS trial is different from those who participated in the prior TRITON-TIMI 38 trial, where almost all ACS patients underwent percutaneous intervention."

The TRILOGY ACS study was conducted by Daiichi Sankyo and Eli Lilly and Co. in conjunction with the Duke Clinical Research Institute, one of the world's leading academic clinical research organizations and a part of Duke University Medical Center in Durham, N.C.

For more information: http://clinicaltrials.gov/ct2/show/NCT00699998

Related Content

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

News | Cardiovascular Clinical Studies | July 22, 2020
July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to re
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp