Comparison Three vs Twelve Months of Dual Anti-Platelet Therapy After Stent Implantation

Summary

Participation Requirements

Description

This study will recruit 2,446 subjects with stable coronary artery disease in no more than 40 research centers in China. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 12 month of DAPT after implanting Firehawk™ coronary stent.Clinical follow-up will be carried out...

This study will recruit 2,446 subjects with stable coronary artery disease in no more than 40 research centers in China. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 12 month of DAPT after implanting Firehawk™ coronary stent.Clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months, 18 months, 2 years and 3 years after index procedure.The primary study endpoint is Net Adverse Clinical and Cerebral Events (NACCE), a composite of all-cause death, myocardial infarction (MI), cerebral vascular accident (CVA) and major bleeding (academic research consortium [ARC] definition and GUSTO definition) at 18 months. Subjects that complete of 18 months follow-up will be regarded as having completed the primary endpoint. The secondary study endpoints contain ARC defined stent thrombosis (ST) at all study time-points; NACCE at 30 days,6,12,24 and 36 months of follow-up;major adverse cardiovascular events (MACE),major adverse cardiovascular and cerebral events (MACCE),target lesion revascularization (TLR),target lesion failure(TLF),ST at 30 days,6,12 ,18,24 and 36 months of follow-up; major bleeding at 1, 3, 6, 12 ,18,24 and 36 months of follow up; as well as cost-effective at 18 months of follow-up.

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