Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease

  • STATUS
    Recruiting
  • End date
    Jul 30, 2023
  • participants needed
    1720
  • sponsor
    Shanghai MicroPort Medical (Group) Co., Ltd.
Updated on 1 March 2022
aspirin
coronary artery disease
stroke
sirolimus
ejection fraction
clopidogrel
percutaneous coronary intervention
antiplatelet therapy
ischemia
dapt
bypass graft
biodegradable polymer
arterial disease

Summary

This study is to assess the clinical non-inferiority of 1 month (short-term) vs 6 months (long-term) of dual anti-platelet therapy in patients undergoing percutaneous intervention implanted sirolimus -eluting stent with abluminal grooves containing a biodegradable polymer in High Bleeding Risk patients with coronary artery disease.

Description

This is a prospective, double -blind,multi-center,randomized controlled trial. Approximately 1,720 subjects in high bleeding risk with coronary artery disease will be enrolled in no more than 40 research centers in China. All participants met the inclusion criteria will be 1:1 randomized to 1 month or 6months of DAPT after implanting Firehawk coronary stent. Clinical follow-up will be carried out at 30 days, 6 months, 12 months, 2 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 ([BARC] definition) at 12 months. Subjects that complete of 12 months follow-up will be regarded as having completed the primary endpoint. The secondary study endpoints contain cost-effectiveness at 12 months, ARC defined stent thrombosis (ST) ; NACCE ;major adverse cardiovascular events (MACE),major adverse cardiovascular and cerebral events (MACCE),target lesion revascularization (TLR),target vessel failure(TVF) , major bleeding at 30 days,6,12 and 24 months of follow-up.

Details
Condition Coronary Disease, Drug Eluting Stent, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
Treatment 6 months DAPT, 1 month DAPT
Clinical Study IdentifierNCT03287167
SponsorShanghai MicroPort Medical (Group) Co., Ltd.
Last Modified on1 March 2022

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