Shanghai, China – On January 8, the launch meeting of the Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") pivotal study, the TARGET DAPT trial, which is focused on shortening DAPT duration for PCI patients after drug-eluting stent implantation, was held at Zhongshan Hospital Affiliated to Fudan University ("Zhongshan Hospital") in Shanghai, China. The TARGET DAPT trial is initiated by Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"). A total of 40 investigators and leaders attended the meeting, including Zhongshan Hospital Vice President Juying Qian, Prof. Feng Zhang, Prof. Lei Ge and Dr. Ming Zheng, Vice President of MicroPort® Clinical Science & Medical Affairs, Dr. Ming Zheng, who is also Dean of MicroPort® Knowledge & Action Medical Training Institute.
The TARGET DAPT trial is a prospective, multi-center, randomized controlled clinical trial, which is led by the Academician. Junbo Ge from Zhongshan Hospital. This trial aims to assess the safety and effectiveness of 3-month versus 12-month dual antiplatelet therapy in patients undergoing PCI with Firehawk® implantation. The study plans to recruit 2,446 subjects at up to 40 hospitals in China with successful Firehawk® implantation. All subjects meeting the inclusion criteria will be 1:1 randomized into the 3-month or 12-month DAPT group. The primary study endpoint is net adverse clinical and cerebral events ("NACCE") rate at 18 months. The secondary endpoints include the incidence of major adverse cardiovascular and cerebral events ("MACCE"), all-cause mortality, major bleeding (BARC definition), as well as the economic endpoint, that is the cost and benefit ratio of subjects at 18 months after the randomization. Subjects in TARGET DAPT will be followed for 36 months.
Prof. Feng Zhang announced the beginning of the meeting on behalf of Academician Ge. Prof. Feng Zhang stressed that MicroPort® Firehawk® was the best drug-eluting stent worldwide, and the clinical results of the TARGET AC trial had already been published in the Lancet, the world leading medical journal. The results from the OCT (Optical Coherence Tomography) sub-study of TARGET AC trial showed a 3-month stent strut cover rate of 99.9%, providing sufficient imaging evidence for 3-month DAPT after Firehawk® implantation. Furthermore, sufficient clinical evidence needs to be obtained through the TARGET DAPT trial, implying this study of extraordinary significance. It is also a highly scientific and rigorous big-scale clinical trial, which will have the all-out support from the department of Prof. Feng Zhang. He also hoped that all the investigators strictly follow the study protocol and GCP requirement and wished an early completion of enrollment and publication of the results, providing a viable, safe and effective treatment strategy for the DAPT after drug-eluting stent implantation in PCI patients.
Dr. Ming Zheng gave a speech on the project launch and an introduction to the background of the trial. The TARGET DAPT clinical trial is a pivotal study of Firehawk® and a key part of a series of global clinical trials. He stressed the high standard of the study, with a Silber-Score of 9, and expected that the clinical data to be published would support the conclusion that the Firehawk® implantation could shorten the duration of DAPT and bring about massive health economic benefit. Meanwhile, Dr. Ming Zheng emphasized the importance of quality control of the study. He said that Zhongshan Hospital had the resources of excellent trial experiences and outstanding investigators, and the clinical study could be completed in line with the strict quality requirement.
On January 10, Prof. Feng Zhang enrolled the first two subjects, who were randomized into the 3-month DAPT group and the 12-month DAPT group respectively. The day marked that the TARGET DAPT trial had officially entered the phase of enrollment.
In the future, MicroPort® will continue to steadily advance its plan of a series of global clinical studies. MicroPort® believes that with the support of the growing data from the global clinical studies, the conclusion that Firehawk® can shorten DAPT and reduce the burden of medical expenses will be further verified and bring hope to global patients.