A Prospective, Double -Blind ,Multi-center,Randomized Controled Trial of Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Sirolimus- Eluting Stent With Abluminal Grooves Containing A Biodegradable Polymer (FirehawkTM Stent ) in High Bleeding Risk Patients With Coronary Artery Disease
Overview
- Phase
- Phase 4
- Intervention
- 1 month DAPT
- Conditions
- Coronary Disease
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Enrollment
- 1720
- Locations
- 1
- Primary Endpoint
- Net Adverse Clinical and Cerebral Events (NACCE)
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years;
- •Subjects (or legal guardians) understand the testing requirements and procedures, and provide written informed consent;
- •Subjects could undergo percutaneous coronary intervention (PCI);
- •Subjects have symptomatic coronary artery disease or have confirmed asymptomatic ischemia;
- •Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);
- •Left ventricular ejection fraction (LVEF) within 60 days ≥ 30%;
- •Subjects were willing to accept the trial plan calls for all subsequent evaluations;
- •Subjects can endure 6 months dual anti-platelet therapy, and met one or more criteria as the following:
- •1.Age ≥ 75years; 2.Subjects with hemoglobin\<10g/dL, or subjects received transfusion therapy 4 weeks ago; 3.Subjects with renal insufficiency (eGFR \< 60 ml / min);
- •Subjects with HAS-BLED score ≥3.0; 5.Femal patients with acute cononary syndrome; 6.BMI \< 18.5 Kg/M2; 7.Subjects with congestive heart failure and with LVEF30%-50%; 8.Subjects had a history of hospitalization due to bleeding; 9.Subjects with thrombocytopenia (platelet \< 100,000 / mm3); 10.Subjects had a histroy of intracranial hemorrhage; 11.Subjects had a histroy of intracranial ischemia stroke in 6 months; 12.Subjects plan to receive non-steroidal anti-inflammatory or steroid treatment for more than 30 days after the baseline PCI; 14.Subjects were expected to receive additional treatment after PCI and cannot undergo long-term DAPT therapy; 15.Subjects had a history of stomach ulcers or active ulcers.
Exclusion Criteria
- •Subjects recently suffer from MI (within 4 week) and ECG changes/clinical symptoms consistent with AMI, or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) and at least one of the following :
- •CK-MB\> 3ULN, regardless of the value of total CK;
- •If CK-MB or CK was not detected, but cTN\> 1ULN, and at least one of the following:
- •Ischemic symptoms and ECG changes of new ischemia;
- •Development of pathologic Q waves in the ECG;
- •Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- •Subject had Re-MI before randomized;
- •Subject with hemodynamic instability (Killip class IV);
- •Subjects were detected ventricular aneurysm greater than 3.0\*2.0cm or intraventricular thrombosis by cardiac ultrasonography in 30 days;
- •Subjects with Life-threatening arrhythmias;
Arms & Interventions
1 month DAPT intervention
After implantation of Firehawk coronary stents, 860 subjects in intervention group will be given dual anti-platelet therapy (DAPT) including aspirin and clopidogrel for 1 month， then will be given aspirin and placebo for next 5 months.
Intervention: 1 month DAPT
6 months DAPT intervention
After implantation of Firehawk coronary stents, 860 subjects in control group will be given dual anti-platelet therapy (DAPT) including aspirin and clopidogrel for 6 months.
Intervention: 6 months DAPT
Outcomes
Primary Outcomes
Net Adverse Clinical and Cerebral Events (NACCE)
Time Frame: At 12 months after index procedure
A composite of all-cause death, MI, cerebral vascular accident (CVA) and major bleeding at 18 months
Secondary Outcomes
- Major Bleeding(In hospital and at 30 days,6, 12 and 24 months after index procedure)
- Stent Thrombosis (per ARC definition)(In hospital and at 30 days,6, 12 and 24 months after index procedure)
- Non-Cardiac Death(In hospital and at 30 days,6, 12 and 24 months after index procedure)
- Death (All cause, Cardiac, Non-cardiac)(In hospital and at 30 days,6, 12 and 24 months after index procedure)
- Target Vessel Revascularization (TVR)(In hospital and at 30 days,6, 12 and 24 months after index procedure)
- Target lesion Revascularization (TLR)(In hospital and at 30 days,6, 12 and 24 months after index procedure)
- Target Lesion Failure (TLF)(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)(In hospital and at 30 days,6, 12 and 24 months after index procedure)
- Target Vessel Failure (TVF)(In hospital and at 30 days,6, 12 and 24 months after index procedure)
- Major Adverse Cardiac and Cerebral Events(MACCE)(In hospital and at 30 days,6, 12 and 24 months after index procedure)
- Net Adverse Clinical and Cerebral Events (NACCE)(In hospital and at 30 days,6, 12 and 24 months after index procedure)
- Cardiac Death(In hospital and at 30 days,6, 12 and 24 months after index procedure)