Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI
- Conditions
- ST Elevation Myocardial Infarction
- Interventions
- Registration Number
- NCT03822975
- Lead Sponsor
- Shenyang Northern Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6016
- Any age;
- STEMI patients undergoing primary PCI with ST elevationβ₯1mm inβ₯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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Heparin unfractionated Heparin Heparin alone during primary PCI Bivalirudin Bivalirudin Bivalirudin with prolonged full dose infusion during primary PCI
- Primary Outcome Measures
Name Time Method Composite of all-cause death or BARC type 3~5 bleeding 30 days BARC=Bleeding academic research consortium
- Secondary Outcome Measures
Name Time Method BARC type 2-5 bleeding 30 days BARC=Bleeding academic research consortium
Stent thrombosis 30 days Definite or probable stent thrombosis according to Academic Research Consortium
Thrombocytopenia 30 days defined as platelet counts less than 150\*10\^9/L after treatment
All cause mortality 1 years BARC type 3-5 bleeding 30 days BARC=Bleeding academic research consortium
Major adverse cardiac and cerebral events (MACE) 30 days MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization
Net adverse clinical events (NACE) 30 days NACE is defined as a composite of MACE or BARC type 3-5 bleeding
Composite of all-cause death or BARC type 2-5 bleeding 30 days BARC=Bleeding academic research consortium
Trial Locations
- Locations (85)
Linquan County Peoples Hospital
π¨π³Fuyang, Anhui, China
Bengbu Second People's Hospital
π¨π³Bengbu, Anhui, China
Fu Yang People'S Hospital
π¨π³Fuyang, Anhui, China
NO.2 People's Hospital of Fuyang City
π¨π³Fuyang, Anhui, China
Taihe County People'S Hospital
π¨π³Fuyang, Anhui, China
Bozhou Peoples Hospital
π¨π³Haozhou, Anhui, China
Huainan Oriental Hospital Group Affiliated Hospital of Anhui University of Science & Technology
π¨π³Huainan, Anhui, China
The First Hospital of Anhui University of Science&Technology
π¨π³Huainan, Anhui, China
Suzhou Municipal Hospital
π¨π³Suzhou, Anhui, China
Chongqing University Fuling Hospital
π¨π³Chongqing, Chongqing, China
Beijing Luhe Hospital.Capital Medical University
π¨π³Beijing, Beijing, China
The First Hospital of Lanzhou University
π¨π³Lanzhou, Gansu, China
Hengshuicardiovascularhospital
π¨π³Hengshui, Hebei, China
Kaifeng Central Hospital
π¨π³Kaifeng, Henan, China
The First People'S Hospital of Ruzhou
π¨π³Ruzhou, Henan, China
Shangqiu first people's Hospital
π¨π³Shangqiu, Henan, China
The Third Affiliated Hospital Of Xinxiang Medical University
π¨π³Xinxiang, Henan, China
Yuzhoucitypeopleshospital
π¨π³Yuzhou, Henan, China
Fuwai Central China Cardiovascular Hospital
π¨π³Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University Center 2
π¨π³Zhengzhou, Henan, China
The First People'S Hospital of Xinmi
π¨π³Zhengzhou, Henan, China
Lou Di Central Hospital
π¨π³Loudi, Hunan, China
Xiangtan Central Hospital
π¨π³Xiangtan, Hunan, China
Yueyang Central Hospital
π¨π³Yueyang, Hunan, China
Jiangsutaizhou Peoples Hospital
π¨π³Taizhou, Jiangsu, China
Ganzhou Municipal Hospital
π¨π³Ganzhou, Jiangxi, China
The Jiangxi Provincial People's Hospital
π¨π³Nanchang, Jiangxi, China
China-Japan Union Hospital of Jilin University
π¨π³Chang chun, Jilin, China
The Second Hospital of Jilin University
π¨π³Chang chun, Jilin, China
Itchoshtal Tonjinee Colere Hoatono Innehatyor Seene Ano Thohholdcy
π¨π³Wuhan, Hubei, China
Wuhanasia Heart Hospital
π¨π³Wuhan, Hubei, China
Yanbian University Hospital
π¨π³Yanbian, Jilin, China
Jiangpiqiao99@sina.com
π¨π³Diaobingshan, Liaoning, China
General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group
π¨π³Benxi, Liaoning, China
Fushun Central Hospital
π¨π³Fushun, Liaoning, China
Jinan Central Hospital
π¨π³Jinan, Shandong, China
Yan 'an university Affiliated Hospital
π¨π³Yanan, Shanxi, China
The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
π¨π³Luzhou, Sichuan, China
General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
π¨π³Fuxin, Liaoning, China
Zao Zhuang Central Hospital Of Shandong Guoxin Healthcare Group
π¨π³Zaozhuang, Shandong, China
The Amliated HospitalofNorthwest University Xi'an No.3 Hospital
π¨π³Xi'an, Shanxi, China
General Hospital of Northern Theater Command
π¨π³Shenyang, Liaoning, China
The Second Hospital of Shen Yang Medical College
π¨π³Shenyang, Liaoning, China
Department of Cardiology, Tangdu Hospital, Airforce Medical University
π¨π³Xi'an, Shanxi, China
The Fourth Affiliated Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
Heze Mudan People's Hospital
π¨π³Heze, Shandong, China
Tianjin Medical University General Hospital
π¨π³Tianjin, Tianjin, China
The Fifth Affiliated Hospital of Xinjiang Medical University
π¨π³ΓrΓΌmqi, Xinjiang, China
Taizhou Central Hospital
π¨π³Taizhou, Zhejiang, China
Zhejiang Provincial Hospital of Chinese Medicine
π¨π³Hangzhou, Zhejiang, China
Luohe Central Hospital
π¨π³Luohe, Henan, China
Nanjing Firsthospital
π¨π³Nanjing, Jiangsu, China
Peking University Third Hospital Yanqing Hospital
π¨π³Beijing, Beijing, China
Yulin First People's Hospital
π¨π³Yulin, Guangxi, China
Meizhou Peopie's Hospital
π¨π³Meizhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
π¨π³Guiyang, Guizhou, China
Affiliated Hospital Ofzunyi Medical University
π¨π³Zunyi, Guizhou, China
Jiaozuo People's Hospital
π¨π³Jiaozuo, Henan, China
The First Affiliated Hospital of Zhengzhou University Center 1
π¨π³Zhengzhou, Henan, China
Tongji Hospital Tongji Medical College of Hust
π¨π³Wuhan, Hubei, China
First Affiliated Hospital Of Gannan Medical University
π¨π³Ganzhou, Jiangxi, China
Chifeng College Affiliated Hospital
π¨π³Chifeng, Inner Mongolia, China
Xuzhou Central Hospital
π¨π³Xuzhou, Jiangsu, China
Nan Fang Hospital.Ganzhou
π¨π³Ganzhou, Jiangxi, China
The Second Affiliated Hospital Of Nanchang University
π¨π³Nanchang, Jiangxi, China
Thefirstaffiliated Hospitalofnanchang University
π¨π³Nanchang, Jiangxi, China
Dalian No.3 People'S Hospital
π¨π³Dalian, Liaoning, China
General Hospital of Fushun Mining Industry Group of Liaoning Health Industry Group
π¨π³Fushun, Liaoning, China
Heze Municipal Hospital
π¨π³Heze, Shandong, China
The Fifth People's Hospital of Jinan
π¨π³Jinan, Shandong, China
Shandong Scend Provincial General Hosptial
π¨π³Jinan, Shandong, China
Qingdao Municipal Hospital
π¨π³Qingdao, Shandong, China
The People's Hospital ofXin Tai City
π¨π³Xintai, Shandong, China
Taian City Central Hospital
π¨π³Tai'an, Shandong, China
Datong Third People'S Hospiatl
π¨π³Datong, Shanxi, China
Shanxi Cardiovascular Hospital
π¨π³Taiyuan, Shanxi, China
The Second Affiliated Hospital Of Xian Jiaotong University
π¨π³Xi'an, Shanxi, China
The First Hospital of Liangshan
π¨π³Xichang, Sichaun, China
The People's Hospital Of Pingchang
π¨π³Bazhong, Sichuan, China
"West China Hospital Sichuan University"
π¨π³Chengdu, Sichuan, China
Hospital of Chengdu University of TCM
π¨π³Chengdu, Sichuan, China
Chengdu Second People'S Hospital
π¨π³Chengdu, Sichuan, China
Tianjin Chest Hospital
π¨π³Tianjin, Tianjin, China
Yunnan St.John'S Hospital
π¨π³Kunming, Yunnan, China
Xi Chang People'S Hospital
π¨π³Xichang, Sichuan, China