Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System
- Conditions
- Coronary Heart Disease
- Interventions
- Drug: Single anti-platelet therapyDrug: Dual anti-platelet therapy
- Registration Number
- NCT04995159
- Lead Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2150
- Age 18 or above, male or non-pregnant female.
- Evidence of myocardial ischemia (e.g., stable angina, unstable angina, medium-low risk NSTEMI, STEMI with onset more than 1 week, old myocardial infarction or asymptomatic myocardial ischemia), and suitable for PCI surgery.
- The target lesion is in-situ coronary artery lesion, the total length of single lesion is no more than 40mm (the total length of stent is no more than 48mm), and the diameter of the target lesion is between 2.75mm and 3.75mm (visual measurement).
- The diameter stenosis of target lesion is ≥70% in visual (or ≥50% with clinical evidence of myocardial ischemia in that range), and the TIMI blood flow is greater than grade 1.
- The stent with diameter more than 3.0mm is allowed to overlap with another stent once, the overlapping methods could be edge to edge or at most 1mm overlap. The total number of stents per patient is no more than 4, with a maximum of 2 stents per vessel (the 2.75mm diameter stent is not allowed to overlap).
- Patient with indications for coronary artery bypass surgery.
- Aspirin and clopidogrel could be used continuously during the study.
- Patient who can understand the purpose of this trial, is willing to participate in the trial and to conduct clinical follow-up as required by the study protocol.
- Acute ST-segment elevation myocardial infarction within 1 week.
- Left main coronary artery disease, branch vessel diameter≥2.0mm, three-vessel coronary artery disease and bridge vessel disease; visible thrombus in the target vessel.
- Severe distortion, severe calcification that cannot be successfully predilated, and other lesions that are not suitable for stent delivery and deployment.
- Intra-stent restenosis.
- Severe heart failure (NYHA≥III or left ventricular ejection fraction<35%).
- Severe renal insufficiency, eGFR<30ml/min/1.73m2 or serum creatinine>2.5mg/dL (221μmol/L).
- Patients with bleeding tendency, active gastrointestinal ulcer, history of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within half a year, fundus hemorrhage affecting vision, antiplatelet agents and anticoagulant treatment contraindications who cannot receive antithrombotic therapy.
- Patients requiring long-term oral anticoagulants during the study period.
- Patients who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- Patients with malignancies, organ transplants, or drug addiction that can seriously affect study compliance.
- Patients with contraindications to aspirin, clopidogrel or ticagrelor.
- Known allergy to aspirin, clopidogrel, ticagrelor, heparin, contrast agent, polylactic acid polymer and rapamycin.
- Thrombosis occurred during previous clopidogrel treatment.
- Life expectancy is less than 36 months.
- Participated in clinical trials of other drugs or medical devices before enrollment and failed to meet the time limit of the primary end point.
- Patients who will have elective surgery within a year and need to discontinue aspirin, clopidogrel or ticagrelor.
- Subjects are deemed unsuitable for enrollment by investigators.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Poststent SAPT treatment cohort Single anti-platelet therapy receiving the treatment with NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System of Lepu Medical combined with SAPT strategy Poststent DAPT treatment cohort Dual anti-platelet therapy receiving the treatment with NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System of Lepu Medical combined with DAPT strategy
- Primary Outcome Measures
Name Time Method Net adverse clinical event (NACE) 3 years 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.
- Secondary Outcome Measures
Name Time Method Target lesion failure (TLF) 3 years Target lesion failure (TLF) includes cardiac death, target vessel myocardial infarction (TV-MI) and ischemic-driven target lesion revascularization (ID-TLR).
Comparison of net adverse clinical events 30 days, 6 months, 1 year, 2 years, 4 years, and 5 years Bleeding events of grade 3 and 5 as defined by BARC 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 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 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years Comparison of target lesion failures 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years Patient-oriented composite endpoint (PoCE) 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years Patient-oriented composite endpoint (PoCE) includes all-cause death, all MI, any revascularization, and stroke.
Ischemic-driven target lesion revascularization (iTLR) 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years Ischemic-driven target vessel revascularization (iTVR) 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years All cardiac revascularization 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years All cardiac revascularization includes PCI and CABG.
Two types of stent thrombosis events as defined by BRS_ARC2 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Trial Locations
- Locations (114)
Yingtan People's Hospital
🇨🇳Yingtan, Jiangxi, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The First Affiliated Hospital with Anhui Medical University
🇨🇳Hefei, Anhui, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Beijing Chaoyang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Anzhen Hospital, Capital Medical University-12 Ward
🇨🇳Beijing, Beijing, China
Beijing Shijitan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Anzhen Hospital, Capital Medical University-33 Ward
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Xuan Wu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Gansu Provincial Hospital
🇨🇳Lanzhou, Gansu, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Foshan First People's Hospital
🇨🇳Foshan, Guangdong, China
Shantou Central Hospital
🇨🇳Shantou, Guangdong, China
Shenzhen University General Hospital
🇨🇳Shenzhen, Guangdong, China
The Third Affiliated Hospital of Guangdong Medical University
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Zhanjiang Central People's Hospital
🇨🇳Zhanjiang, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
🇨🇳Zhuhai, Guangdong, China
Guilin People's Hospital
🇨🇳Guilin, Guangxi, China
Liuzhou People's Hospital
🇨🇳Liuzhou, Guangxi, China
Liuzhou Worker's Hospital
🇨🇳Liuzhou, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The First People's Hospital of Nanning
🇨🇳Nanning, Guangxi, China
Yulin First People's Hospital
🇨🇳Yulin, Guangxi, China
Guizhou Provincial People's Hospital
🇨🇳Guiyang, Guizhou, China
Haikou People's Hospital
🇨🇳Haikou, Hainan, China
Sanya Central Hospital (Hainan Third People's Hospital)
🇨🇳Sanya, Hainan, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Hengshui People's Hospital
🇨🇳Hengshui, Hebei, China
Hebei General Hospital
🇨🇳Shijiazhuang, Hebei, China
the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
🇨🇳Shijiazhuang, Hebei, China
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, China
The Fourth Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The Second Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Nanyang Second General Hospital
🇨🇳Nanyang, Henan, China
Xinxiang Central Hospital
🇨🇳Xinxiang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Zhengzhou Central Hospital
🇨🇳Zhengzhou, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Henan Provincial Chest Hospital
🇨🇳Zhengzhou, Henan, China
The Second Affiliated Hospital, Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital, Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of Chinese Medicine
🇨🇳Zhengzhou, Henan, China
Fuwai Central China Cardiovascular Hospital
🇨🇳Zhengzhou, Henan, China
Fifth Hospital in Wuhan
🇨🇳Wuhan, Hubei, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China
Xiangtan Central Hospital
🇨🇳Xiangtan, Hunan, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science
🇨🇳Baotou, Inner Mongolia, China
Gynecology of Huai'an First People's Hospital, Nanjing Medical University
🇨🇳Huai'an, Jiangsu, China
Affiliated Lianyungang Hospital of Nanjing University of Chinese Medicine
🇨🇳Lianyungang, Jiangsu, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Xuzhou Cancer Hospital
🇨🇳Xuzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
The First Affiliated Hospital of Gannan Medical College
🇨🇳Ganzhou, Jiangxi, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Weihai Central Hospital
🇨🇳Weihai, Shandong, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
The People's Hospital of Liaoning Province
🇨🇳Shenyang, Liaoning, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Zibo Central Hospital
🇨🇳Zibo, Shandong, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoning, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
General Hospital of Northern Theater Command
🇨🇳Shenyang, Liaoning, China
Ruijin Hospital Affiliated to School of Medicine, Shanghai Jiaotong University
🇨🇳Shanghai, Shanghai, China
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China
Xinhua Hospital Affiliated to School of Medicine, Shanghai Jiaotong University
🇨🇳Shanghai, Shanghai, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai 6th People's Hospital
🇨🇳Shanghai, Shanghai, China
Baoji Central Hospital
🇨🇳Baoji, Shanxi, China
Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Shanxi Cardiovascular Hospital
🇨🇳Taiyuan, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
First Affiliated Hospital of the Fourth Military Medical University
🇨🇳Xi'an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Tangdu Hospital of the Fourth Military Medical University of the PLA
🇨🇳Yanan, Shanxi, China
Yan'an University Affiliated Hospital
🇨🇳Yanan, Shanxi, China
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China
Teda International Cardiovascular Hospital
🇨🇳Tianjin, Tianjin, China
People's Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Urumqi, Xinjiang, China
Fuwai Yunnan Cardiovascular Hospital
🇨🇳Kunming, Yunnan, China
The First People's Hospital of Yunnan
🇨🇳Kunming, Yunnan, China
Sir Run Run Shaw Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
The Second Affiliated Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
The Second Affiliated Hospital of Hainan Medical University
🇨🇳Haikou, Hainan, China
Nanyang Central Hospital
🇨🇳Nanyang, Henan, China
The 7th People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Shanxi Provincial Hospital
🇨🇳Xi'an, Shanxi, China
Beijing Anzhen Hospital, Capital Medical University-28 Ward
🇨🇳Beijing, Beijing, China
Beijing Jingmei Group General Hospital
🇨🇳Beijing, Beijing, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China