Prospective multicentre open-label randomised controlled trial of 3-month versus 12-month dual antiplatelet therapy after implantation of the new generation biodegradable polymer sirolimus TARGET-eluting coronary stent: protocol of the TARGET DAPT trial. Issue 12 (17th December 2019)

• Record Type: Journal Article
• Authors: Yang, Hongbo; Zhang, Feng; Yang, Ji'e; Zheng, Ming; Cao, Ruifen; Dai, Yuxiang; Li, Chenguang; Yao, Kang; Qian, Juying; Ge, Junbo
• Is Part Of: BMJ open. Volume 9:Issue 12(2019)
• Publication Date: 2019-12-17
• Subjects: coronary heart disease -- coronary intervention -- protocols & guidelines; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-033774
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Dual antiplatelet therapy (DAPT) with aspirin and thienopyridine is required after placement of coronary stents to prevent thrombotic complications. However, current recommendation for duration of DAPT remains controversial. Firehawk is a biodegradable polymer applied to recessed abluminal grooves, sirolimus target-eluting stent associated with early excellent healing response and almost complete strut coverage, as well as possibly reduced myocardial ischaemic events. But the optimal DAPT duration for such a new generation stent is less known. Therefore, the present trial seeks to evaluate the safety and efficacy of 3-month versus 12-month DAPT in broad patients receiving Firehawk stents. Methods and analysis: The TARGET DAPT study is designed to access the benefits and risks of short-term (3 months) versus long-term (12 months) DAPT in preventing stent thrombosis or major adverse cardiovascular and cerebrovascular events in subjects undergoing percutaneous coronary intervention for the treatment of coronary artery obstructive lesions. The TARGET DAPT trial is a large, prospective, multicentre, randomised (1:1) non-inferiority clinical trial that will enrol 2446 subjects treated with Firehawk stents. The primary endpoint is net adverse clinical and cerebral events, a composite of all-cause death, myocardial infarction, cerebral vascular accident and major bleeding (BARC 2, 3 or 5) at 18 months clinical follow-up postindex procedure. Ethics and dissemination: Ethics approval was obtained from the Ethics Committee of Zhongshan Hospital, Shanghai. The reference number is B2018-146R. Study findings will be made available to interested participants. Study results will be submitted for publication in a peer-reviewed journal. Also the protocol will be submitted and approved by the institutional Ethics Committee at each participating clinical centre. Trial registration: NCT03008083