Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04995159
• Other study ID #: OPT-BRS
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: January 2028

Study information

• Verified date: July 2021
• Source: Lepu Medical Technology (Beijing) Co., Ltd.
• Contact: Ting Zhang
• Phone: +86-010-80120666
• Email: ting_zhang[@]lepumedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 2150
• Est. completion date: January 2028
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Single anti-platelet therapy
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.
• Dual anti-platelet therapy
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.

Locations

Country	Name	City	State
China	Baoji Central Hospital	Baoji	Shanxi
China	The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science	Baotou	Inner Mongolia
China	Beijing Anzhen Hospital, Capital Medical University-12 Ward	Beijing	Beijing
China	Beijing Anzhen Hospital, Capital Medical University-28 Ward	Beijing	Beijing
China	Beijing Anzhen Hospital, Capital Medical University-33 Ward	Beijing	Beijing
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Jingmei Group General Hospital	Beijing	Beijing
China	Beijing Luhe Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Shijitan Hospital, Capital Medical University	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Xuan Wu Hospital, Capital Medical University	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Affiliated Zhongshan Hospital of Dalian University	Dalian	Liaoning
China	Dalian Municipal Central Hospital Affiliated of Dalian Medical University	Dalian	Liaoning
China	Foshan First People's Hospital	Foshan	Guangdong
China	The First Affiliated Hospital of Gannan Medical College	Ganzhou	Jiangxi
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Guangdong Medical University	Guangzhou	Guangdong
China	Guilin People's Hospital	Guilin	Guangxi
China	Guizhou Provincial People's Hospital	Guiyang	Guizhou
China	Haikou People's Hospital	Haikou	Hainan
China	The Second Affiliated Hospital of Hainan Medical University	Haikou	Hainan
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 Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The First Affiliated Hospital with Anhui Medical University	Hefei	Anhui
China	Hengshui People's Hospital	Hengshui	Hebei
China	Gynecology of Huai'an First People's Hospital, Nanjing Medical University	Huai'an	Jiangsu
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Jingzhou Central Hospital	Jingzhou	Hubei
China	Fuwai Yunnan Cardiovascular Hospital	Kunming	Yunnan
China	The First People's Hospital of Yunnan	Kunming	Yunnan
China	Gansu Provincial Hospital	Lanzhou	Gansu
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Affiliated Lianyungang Hospital of Nanjing University of Chinese Medicine	Lianyungang	Jiangsu
China	Liuzhou People's Hospital	Liuzhou	Guangxi
China	Liuzhou Worker's Hospital	Liuzhou	Guangxi
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	The First People's Hospital of Nanning	Nanning	Guangxi
China	Nanyang Central Hospital	Nanyang	Henan
China	Nanyang Second General Hospital	Nanyang	Henan
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Sanya Central Hospital (Hainan Third People's Hospital)	Sanya	Hainan
China	Changhai Hospital	Shanghai	Shanghai
China	Ruijin Hospital Affiliated to School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai
China	Shanghai 6th People's Hospital	Shanghai	Shanghai
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	Shanghai General Hospital	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai
China	Shantou Central Hospital	Shantou	Guangdong
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	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning
China	Shenzhen University General Hospital	Shenzhen	Guangdong
China	Hebei General Hospital	Shijiazhuang	Hebei
China	the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force	Shijiazhuang	Hebei
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi
China	Teda International Cardiovascular Hospital	Tianjin	Tianjin
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang
China	Weihai Central Hospital	Weihai	Shandong
China	Fifth Hospital in Wuhan	Wuhan	Hubei
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui
China	First Affiliated Hospital of the Fourth Military Medical University	Xi'an	Shanxi
China	Shanxi Provincial Hospital	Xi'an	Shanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Xiangtan Central Hospital	Xiangtan	Hunan
China	Xingtai People's Hospital	Xingtai	Hebei
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Xinxiang Central Hospital	Xinxiang	Henan
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Xuzhou Cancer Hospital	Xuzhou	Jiangsu
China	Tangdu Hospital of the Fourth Military Medical University of the PLA	Yanan	Shanxi
China	Yan'an University Affiliated Hospital	Yanan	Shanxi
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Yingtan People's Hospital	Yingtan	Jiangxi
China	Yulin First People's Hospital	Yulin	Guangxi
China	Zhanjiang Central People's Hospital	Zhanjiang	Guangdong
China	Fuwai Central China Cardiovascular Hospital	Zhengzhou	Henan
China	Henan Provincial Chest Hospital	Zhengzhou	Henan
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The 7th People's Hospital of Zhengzhou	Zhengzhou	Henan
China	The First Affiliated Hospital of Henan University of Chinese Medicine	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 Second Affiliated Hospital, Zhengzhou University	Zhengzhou	Henan
China	Zhengzhou Central Hospital	Zhengzhou	Henan
China	The Fifth Affiliated Hospital of Sun Yat-sen University	Zhuhai	Guangdong
China	Zibo Central Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Lepu Medical Technology (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Secondary	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).	3 years
Secondary	Comparison of net adverse clinical events		30 days, 6 months, 1 year, 2 years, 4 years, and 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Comparison of target lesion failures		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Secondary	Patient-oriented composite endpoint (PoCE)	Patient-oriented composite endpoint (PoCE) includes all-cause death, all MI, any revascularization, and stroke.	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Secondary	Ischemic-driven target lesion revascularization (iTLR)		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Secondary	Ischemic-driven target vessel revascularization (iTVR)		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Secondary	All cardiac revascularization	All cardiac revascularization includes PCI and CABG.	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Secondary	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