A Prospective Multi-center Open-label Controlled Trial of Comparison 3 vs 12 Months of Dual Anti-Platelet Therapy After Implantation of Firehawk Sirolimus Target- Eluting Stent in Patients With Stable Coronary Artery Disease
Overview
- Phase
- Phase 4
- Intervention
- 3 months DAPT
- Conditions
- Drug-Eluting Stents
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Enrollment
- 2446
- Locations
- 1
- Primary Endpoint
- Net Adverse Clinical and Cerebral Events (NACCE)
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years;
- •Subjects (or legal guardians) understand the testing requirements and procedures, and provide written informed consent;
- •Subjects with symptomatic coronary artery disease or confirmed asymptomatic ischemia;
- •Target lesion should be new lesion with visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in autologous coronary artery;
- •Subjects willing to accept PCI therapy and to implant Firehawk™ stent only;
- •Left ventricular ejection fraction (LVEF) ≥ 30%;
- •Subjects willing to accept the trial plan calls for all subsequent evaluations.
- •Angiographic Inclusion Criteria:
- •Target lesions must be new and have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in autologous coronary artery;
- •No limitations in target lesion length and number;
Exclusion Criteria
- •Subjects with ST-segment elevation myocardial infarction:
- •Subjects having an organ transplant or waiting for an organ transplant
- •Subjects receiving chemotherapy or going to receive a chemotherapy within 30 days after PCI
- •Subjects undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome
- •Subjects with abnormal counts of platelet and white blood cell (WBC) (investigator assess clinical significance combine normal reference range of laboratory)
- •Subjects with confirmed or suspected liver disease, including hepatitis lab results
- •Subjects with elevated serum creatinine level \>3.0mg/dL or undergoing dialysis therapy
- •Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion
- •Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects
- •Subjects undergoing any PCI treatment in target vessels within 12 months prior to baseline
Arms & Interventions
3 months DAPT Intervention
After implantation of Firehawk coronary stents, all subjects in intervention group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor)for 3 months.
Intervention: 3 months DAPT
12 months DAPT Intervention
After implantation of Firehawk coronary stents, all subjects in control group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor)for 12 months.
Intervention: 12 months DAPT
Outcomes
Primary Outcomes
Net Adverse Clinical and Cerebral Events (NACCE)
Time Frame: At 18 months after index procedure
A composite of all-cause death, MI, cerebral vascular accident (CVA) and major bleeding at 18 months
Secondary Outcomes
- Cost-Effectiveness Ratio (CER)(At 18 months after index procedure)