This study is designed to verify the safety and efficacy of Lepu® NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System combined with different antiplatelet therapies in the treatment of coronary heart disease.
A total of 2150 subjects are planned to be enrolled in this trial. Subjects meeting the inclusion criteria and without exclusion criteria are implanted with NeoVas™ stents and randomly assigned to the experimental group and the control group in a 1:1 ratio. Patients in both groups will receive aspirin in combination with a P2Y12 receptor antagonist in the first year after PCI (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia). Aspirin will be discontinued one year after surgery and clopidogrel will be continued until 5 years after surgery in the experimental group. The control group will continue to take dual antiplatelet (DAPT) drugs, including aspirin and clopidogrel, for 2 more years; then aspirin will be used alone from the 4th year to the 5th year. Subjects will be followed up at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after surgery to observe whether the net adverse clinical events (NACEs) and other end points occur or not.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,150
Aspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Aspirin will be discontinued one year after surgery and clopidogrel will be continued until 5 years after surgery.
Aspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Patients continue to take dual antiplatelet (DAPT) drugs, including aspirin and clopidogrel, for 2 more years; then aspirin will be used alone from the 4th year to the 5th year.
Net adverse clinical event (NACE)
NACE includes POCE (including all-cause death, all non-fatal myocardial infarction (Universal Definition of Myocardial Infarction, 4th Edition), any revascularization, and stroke), and major bleeding events of grade 2, 3, and 5 as defined by BARC.
Time frame: 3 years
Target lesion failure (TLF)
Target lesion failure (TLF) includes cardiac death, target vessel myocardial infarction (TV-MI) and ischemic-driven target lesion revascularization (ID-TLR).
Time frame: 3 years
Comparison of net adverse clinical events
Time frame: 30 days, 6 months, 1 year, 2 years, 4 years, and 5 years
Bleeding events of grade 3 and 5 as defined by BARC
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Bleeding events of grade 2, 3 and 5 as defined by BARC
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Bleeding events of grade 1, 2, 3 and 5 as defined by BARC
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Comparison of target lesion failures
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Patient-oriented composite endpoint (PoCE)
Patient-oriented composite endpoint (PoCE) includes all-cause death, all MI, any revascularization, and stroke.
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The First Affiliated Hospital with Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital, Capital Medical University-12 Ward
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital, Capital Medical University-28 Ward
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital, Capital Medical University-33 Ward
Beijing, Beijing Municipality, China
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
...and 104 more locations
Ischemic-driven target lesion revascularization (iTLR)
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Ischemic-driven target vessel revascularization (iTVR)
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
All cardiac revascularization
All cardiac revascularization includes PCI and CABG.
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Two types of stent thrombosis events as defined by BRS_ARC2
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years