Duke’s Med School, through its Clinical Research Institute arm, just put out its own press release, on this legacy Schering-Plough cardiac drug candidate — do go read it all [graphics shortly]:
. . . .We are pleased that we have gotten a green light from the Data Safety Monitoring Board to continue the trial in more than 20,000 of the patients enrolled,” said Eugene Braunwald, MD, chairman of the TIMI Trial. “It is exciting to study a drug that may improve the care of patients who have had a heart attack or who have peripheral arterial disease. It does not appear to be appropriate in patients who have had a stroke.“. . . .
The primary efficacy endpoint of the study was the first occurrence of any component of the composite of cardiovascular death, heart attack, stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization. The key secondary efficacy endpoint was the first occurrence of any one of the composite of cardiovascular death, heart attack, and stroke.
“While this is an unexpected development, the requisite number of endpoints has been acquired, which provides us with enough information to definitively answer the questions posed by the TRA•CER trial,” said Robert Harrington, MD, director of the DCRI and TRA•CER study chairman. “We are focused on working with our colleagues to conduct a timely closeout of the trial and complete a full analysis of the findings.”
The TRA 2ºP-TIMI 50 and TRA•CER trials are funded by Merck & Co, which is developing vorapaxar. . . .
Stay-tuned, but that sure does sound like a safety signal.