Coronary Heart Disease Clinical Trial
Official title:
Evaluate the Safety and Efficacy of Optimized Antiplatelet Therapy in Patients With Coronary Heart Disease After Implantation of NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System.
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. ;
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