This is an interesting trial as it involved 4 competitors in the stent market. 20,000 individuals are slated to participate and Boston Scientific has signed on their first patient. The trials involve comparing the use of drugs after the placement of the stents and the use of aspirin to monitor which group has the best outcomes. You can read the entire article in it’s entirely as the trials vary a little from one company to the next. The trials are to be conducted worldwide. BD
"This study is the first post-market investigation in which the FDA brought together industry competitors who put aside competition and achieved an unprecedented level of cooperation with regulator s and academia to answer a major public health question," said Margaret A. Hamburg, commissioner of the U.S. Food and Drug Administration.
Participating in the four-year DAPT Study are Natick, Mass.-based Boston Scientific, manufacturer of the Taxus and Promus stents, along with device makers Medtronic Inc. (NYSE:MDT), Abbott Laboratories (NYSE:ABT) and Cordis Corp., the stents arm of healthcare conglomerate Johnson & Johnson (NYSE:JNJ). Drug-makers Bristol-Myers Squibb Co. (NYSE:BMY), Sanofi Pharmaceuticals (NYSE:SNY), Eli Lilly & Co. (NYSE:LLY) and Daiichi-Sankyo Company Ltd. (TYO:4568) also have signed on for the study.
The Harvard Clinical Research Institute, an industry-supported facility based in Boston, enrolled the first of 20,000 individuals slated to participate in the trial in October, 2009. Boston Scientific said its participation will look at the Taxus Liberté stent, which elutes a drug called paclitaxel, and the use of aspirin and Effient, an anti-coagulant made by Eli Lilly and Daiichi Sankyo. The company said it plans to contribute data on the first 1,524 eligible patients from its post-approval study of the Taxus Liberté to the DAPT Study.