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

  • STATUS
    Recruiting
  • participants needed
    2446
  • sponsor
    Shanghai MicroPort Medical (Group) Co., Ltd.
Updated on 27 November 2022
aspirin
sirolimus
ejection fraction
ischemia
dapt
biodegradable polymer

Summary

This study is a prospective,multi-center, open-label, randomized controlled clinical trial,aims to assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients undergoing percutaneous coronary intervention implanted sirolimus target- eluting stent with abluminal grooves containing a biodegradable polymer (Firehawk stent). All participants met the inclusion criteria begin taking aspirin and open-label thienopyridine therapy before index procedure, and will be 1:1 randomized to 3 months or 12 month of DAPT at index procedure.

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 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.

Details
Condition Drug-Eluting Stents, Percutaneous Coronary Intervention
Treatment 3 months DAPT, 12 months DAPT
Clinical Study IdentifierNCT03008083
SponsorShanghai MicroPort Medical (Group) Co., Ltd.
Last Modified on27 November 2022

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