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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,720
Subjects will continue DAPT with clopidogrel and Aspirin (ASA) up to 1 month, after which patients will be given ASA and placebo in next 5 months and then continue on monotherapy with ASA only, unless contraindications for ASA emerge.
Subjects will continue DAPT with clopidogrel and Aspirin (ASA) up to 6 months, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.
The General Hospital of Shenyang Military
Shenyang, Liaoning, China
RECRUITINGNet Adverse Clinical and Cerebral Events (NACCE)
A composite of all-cause death, MI, cerebral vascular accident (CVA) and major bleeding at 18 months
Time frame: At 12 months after index procedure
Target Vessel Revascularization (TVR)
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
Target lesion Revascularization (TLR)
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
Target Vessel Failure (TVF)
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
Target Lesion Failure (TLF)
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
Stent Thrombosis (per ARC definition)
the definite and probable stent thrombosis
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
Major Adverse Cardiac and Cerebral Events(MACCE)
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
Net Adverse Clinical and Cerebral Events (NACCE)
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI)
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
Death (All cause, Cardiac, Non-cardiac)
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
Cardiac Death
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
Non-Cardiac Death
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
Major Bleeding
\[BARC\] definition
Time frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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