The TARGET SAFE trial is a rationale and design study evaluating 1-month versus 6-month dual antiplatelet therapy in 1,720 CAD patients with high bleeding risk, with no clinical results reported yet.
RCT (n=1,720)
Double-blind
1:1 ratio via Interactive Web Response System, stratified by trial site and medically treated diabetes status
Yes
Does 1-month DAPT achieve non-inferior clinical outcomes while maintaining safety compared to 6-month DAPT in CAD patients with high bleeding risk after biodegradable polymer stent implantation?
The TARGET SAFE trial will evaluate whether 1-month DAPT is safe and effective compared to 6-month DAPT in high bleeding risk patients receiving a biodegradable polymer sirolimus-eluting stent.
Abstract Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is the cornerstone for the prevention of ischemic events in patients with coronary artery disease (CAD) who have undergone percutaneous coronary intervention (PCI). However, it remains uncertain whether shortening DAPT from the standard 6–12 months to 1 month can achieve non-inferior clinical outcomes while maintaining safety. The TARGET SAFE study is a prospective, double-blind, multicenter, randomized, parallel-group controlled trial. Approximately 1,720 patients with CAD and high bleeding risk will be enrolled across 32 centers in China. Eligible patients will be randomized in a 1:1 ratio via the Interactive Web Response System, with stratification by trial site and medically treated diabetes status. All enrolled patients will receive either 1 month or 6 months of DAPT after implantation of the abluminal-grooved sirolimus-eluting stent loaded with a biodegradable polymer. Clinical follow-up will be conducted at 30 d, 6 months, 12 months, and 24 months after the procedure. The primary endpoint is net adverse clinical and cerebral events, defined as a composite of all-cause death, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding at 12 months. The secondary endpoints are ranked by clinical importance: target vessel failure, target lesion revascularization, target vessel revascularization, major adverse cardiac and cerebral events, myocardial infarction, death (all-cause, cardiac, non-cardiac), cardiac death or all myocardial infarction, BARC type 2, 3, or 5 bleeding, and definite or probable stent thrombosis at discharge, 30 d, 6 months, 12 months, and 24 months. The primary objective of this study is to generate evidence on the safety and efficacy of 1-month DAPT following implantation of a biodegradable polymer stent in CAD patients with high bleeding risk.
Wang et al. (Mon,) conducted a rct in Coronary artery disease and high bleeding risk (n=1,720). 1-month dual antiplatelet therapy vs. 6-month dual antiplatelet therapy was evaluated on Net adverse clinical and cerebral events (composite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleeding at 12 months). The TARGET SAFE trial is a rationale and design study evaluating 1-month versus 6-month dual antiplatelet therapy in 1,720 CAD patients with high bleeding risk, with no clinical results reported yet.