Clinical trial NCT04995159: Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Bioabsorbable Coronary Artery Rapamycin-eluting Stent System
Optimized Antiplatelet Therapy
Coronary Heart Disease
Randomized Controlled Trial
Lead sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 2150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Net adverse clinical event (NACE)
timeFrame: 3 years
Secondary outcomes:
measure: Target lesion failure (TLF)
timeFrame: 3 years
measure: Comparison of net adverse clinical events
timeFrame: 30 days, 6 months, 1 year, 2 years, 4 years, and 5 years
measure: Bleeding events of grade 3 and 5 as defined by BARC
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
measure: Bleeding events of grade 2, 3 and 5 as defined by BARC
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
measure: Bleeding events of grade 1, 2, 3 and 5 as defined by BARC
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
measure: Comparison of target lesion failures
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
measure: Patient-oriented composite endpoint (PoCE)
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
measure: Ischemic-driven target lesion revascularization (iTLR)
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
measure: Ischemic-driven target vessel revascularization (iTVR)
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
measure: All cardiac revascularization
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
measure: Two types of stent thrombosis events as defined by BRS_ARC2
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital with Anhui Medical University
state: Anhui
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University-12 Ward
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University-28 Ward
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University-33 Ward
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Xuan Wu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Jingmei Group General Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Foshan
country: China
facility: Foshan First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guangdong
city: Shantou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shantou
country: China
facility: The Second Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen University General Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Zhanjiang Central People's Hospital
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guilin
country: China
facility: Guilin People's Hospital
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: The First People's Hospital of Nanning
state: Guangxi
city: Yulin
country: China
facility: Yulin First People's Hospital
state: Guangxi
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Haikou
country: China
facility: Haikou People's Hospital
state: Hainan
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
state: Hainan
city: Sanya
country: China
facility: Sanya Central Hospital (Hainan Third People's Hospital)
state: Hainan
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Hengshui
country: China
facility: Hengshui People's Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
state: Hebei
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Harbin
country: China
facility: The Fourth Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The Second Hospital of Harbin Medical University
state: Heilongjiang
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Nanyang
country: China
facility: Nanyang Second General Hospital
state: Henan
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial Chest Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital, Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The 7th People's Hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital, Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Chinese Medicine
state: Henan
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Fifth Hospital in Wuhan
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science
state: Inner Mongolia
city: Huai'an
country: China
facility: Gynecology of Huai'an First People's Hospital, Nanjing Medical University
state: Jiangsu
city: Lianyungang
country: China
facility: Affiliated Lianyungang Hospital of Nanjing University of Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Cancer Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Ganzhou
country: China
facility: The First Affiliated Hospital of Gannan Medical College
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Yingtan
country: China
facility: Yingtan People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
state: Liaoning
city: Dalian
country: China
facility: Dalian Municipal Central Hospital Affiliated of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Weihai
country: China
facility: Weihai Central Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to School of Medicine, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to School of Medicine, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
state: Shanghai
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of the Fourth Military Medical University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Shanxi Provincial Hospital
state: Shanxi
city: Yanan
country: China
facility: Tangdu Hospital of the Fourth Military Medical University of the PLA
state: Shanxi
city: Yanan
country: China
facility: Yan'an University Affiliated Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Teda International Cardiovascular Hospital
state: Tianjin
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Kunming
country: China
facility: Fuwai Yunnan Cardiovascular Hospital
state: Yunnan
city: Kunming
country: China
facility: The First People's Hospital of Yunnan
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Yaling Han
role: STUDY_CHAIR
References: