Clinical trial NCT03822975: Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI
Official title: Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: Primary percutaneous coronary intervention
anticoagulant agents
bivalirudin
heparin
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 6016
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to investigate if the bivaliruding with prolonged full dose infusion after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a 1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy decisions in STEMI patients.


Eligibility criteria: Inclusion Criteria:

* Any age;
* STEMI patients undergoing primary PCI with ST elevation≥1mm in≥2 contiguous leads or new LBBB with symptom onset 48h;
* Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin);
* Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor);
* The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent.

Exclusion Criteria:

* Not suitable for emergency primary PCI;
* STEMI treated by thrombolysis;
* Patients received heparin, LMWH, fondaparinux, bivalirudin, or GPI within 48 hours before the index PCI;
* Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);
* Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor
* Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study).

Primary outcomes:
measure: Composite of all-cause death or BARC type 3~5 bleeding
timeFrame: 30 days
Secondary outcomes:
measure: All cause mortality
timeFrame: 30 days
measure: BARC type 3-5 bleeding
timeFrame: 30 days
measure: Major adverse cardiac and cerebral events (MACE)
timeFrame: 30 days
measure: Net adverse clinical events (NACE)
timeFrame: 30 days
measure: Composite of all-cause death or BARC type 2-5 bleeding
timeFrame: 30 days
measure: BARC type 2-5 bleeding
timeFrame: 30 days
measure: Stent thrombosis
timeFrame: 30 days
measure: Thrombocytopenia
timeFrame: 30 days
measure: All cause mortality
timeFrame: 1 years
Other outcomes:
Locations:
city: Bengbu
country: China
facility: Bengbu Second People's Hospital
state: Anhui
city: Fuyang
country: China
facility: Fu Yang People'S Hospital
state: Anhui
city: Fuyang
country: China
facility: Linquan County Peoples Hospital
state: Anhui
city: Fuyang
country: China
facility: NO.2 People's Hospital of Fuyang City
state: Anhui
city: Fuyang
country: China
facility: Taihe County People'S Hospital
state: Anhui
city: Haozhou
country: China
facility: Bozhou Peoples Hospital
state: Anhui
city: Huainan
country: China
facility: Huainan Oriental Hospital Group Affiliated Hospital of Anhui University of Science & Technology
state: Anhui
city: Huainan
country: China
facility: The First Hospital of Anhui University of Science&Technology
state: Anhui
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Luhe Hospital.Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital Yanqing Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Fuling Hospital
state: Chongqing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Meizhou
country: China
facility: Meizhou Peopie's Hospital
state: Guangdong
city: Yulin
country: China
facility: Yulin First People's Hospital
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Zunyi
country: China
facility: Affiliated Hospital Ofzunyi Medical University
state: Guizhou
city: Hengshui
country: China
facility: Hengshuicardiovascularhospital
state: Hebei
city: Jiaozuo
country: China
facility: Jiaozuo People's Hospital
state: Henan
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Luohe
country: China
facility: Luohe Central Hospital
state: Henan
city: Ruzhou
country: China
facility: The First People'S Hospital of Ruzhou
state: Henan
city: Shangqiu
country: China
facility: Shangqiu first people's Hospital
state: Henan
city: Xinxiang
country: China
facility: The Third Affiliated Hospital Of Xinxiang Medical University
state: Henan
city: Yuzhou
country: China
facility: Yuzhoucitypeopleshospital
state: Henan
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University Center 1
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University Center 2
state: Henan
city: Zhengzhou
country: China
facility: The First People'S Hospital of Xinmi
state: Henan
city: Wuhan
country: China
facility: Itchoshtal Tonjinee Colere Hoatono Innehatyor Seene Ano Thohholdcy
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of Hust
state: Hubei
city: Wuhan
country: China
facility: Wuhanasia Heart Hospital
state: Hubei
city: Loudi
country: China
facility: Lou Di Central Hospital
state: Hunan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
city: Yueyang
country: China
facility: Yueyang Central Hospital
state: Hunan
city: Chifeng
country: China
facility: Chifeng College Affiliated Hospital
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing Firsthospital
state: Jiangsu
city: Taizhou
country: China
facility: Jiangsutaizhou Peoples Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: First Affiliated Hospital Of Gannan Medical University
state: Jiangxi
city: Ganzhou
country: China
facility: Ganzhou Municipal Hospital
state: Jiangxi
city: Ganzhou
country: China
facility: Nan Fang Hospital.Ganzhou
state: Jiangxi
city: Nanchang
country: China
facility: The Jiangxi Provincial People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital Of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: Thefirstaffiliated Hospitalofnanchang University
state: Jiangxi
city: Chang chun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Chang chun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Yanbian
country: China
facility: Yanbian University Hospital
state: Jilin
city: Benxi
country: China
facility: General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group
state: Liaoning
city: Dalian
country: China
facility: Dalian No.3 People'S Hospital
state: Liaoning
city: Diaobingshan
country: China
facility: Jiangpiqiao99@sina.com
state: Liaoning
city: Fushun
country: China
facility: Fushun Central Hospital
state: Liaoning
city: Fushun
country: China
facility: General Hospital of Fushun Mining Industry Group of Liaoning Health Industry Group
state: Liaoning
city: Fuxin
country: China
facility: General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Shenyang
country: China
facility: The Fourth Affiliated Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The Second Hospital of Shen Yang Medical College
state: Liaoning
city: Heze
country: China
facility: Heze Mudan People's Hospital
state: Shandong
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Scend Provincial General Hosptial
state: Shandong
city: Jinan
country: China
facility: The Fifth People's Hospital of Jinan
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Tai'an
country: China
facility: Taian City Central Hospital
state: Shandong
city: Xintai
country: China
facility: The People's Hospital ofXin Tai City
state: Shandong
city: Zaozhuang
country: China
facility: Zao Zhuang Central Hospital Of Shandong Guoxin Healthcare Group
state: Shandong
city: Datong
country: China
facility: Datong Third People'S Hospiatl
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Xi'an
country: China
facility: Department of Cardiology, Tangdu Hospital, Airforce Medical University
state: Shanxi
city: Xi'an
country: China
facility: The Amliated HospitalofNorthwest University Xi'an No.3 Hospital
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital Of Xian Jiaotong University
state: Shanxi
city: Yanan
country: China
facility: Yan 'an university Affiliated Hospital
state: Shanxi
city: Xichang
country: China
facility: The First Hospital of Liangshan
state: Sichaun
city: Bazhong
country: China
facility: The People's Hospital Of Pingchang
state: Sichuan
city: Chengdu
country: China
facility: "West China Hospital Sichuan University"
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Second People'S Hospital
state: Sichuan
city: Chengdu
country: China
facility: Hospital of Chengdu University of TCM
state: Sichuan
city: Luzhou
country: China
facility: The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
state: Sichuan
city: Xichang
country: China
facility: Xi Chang People'S Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Ürümqi
country: China
facility: The Fifth Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yunnan St.John'S Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of Chinese Medicine
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Yaling Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Liang Z, Qin L, Wang M, Wang X, Zhang H, Liu Y, Li Y, Jia Z, Liu L, Zhang H, Luo J, Dong S, Guo J, Zhu H, Li S, Zheng H, Liu L, Wu Y, Zhong Y, Qiu M, Han Y, Stone GW. Bivalirudin plus a high-dose infusion versus heparin monotherapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomised trial. Lancet. 2022 Nov 26;400(10366):1847-1857. doi: 10.1016/S0140-6736(22)01999-7. Epub 2022 Nov 6.