Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI

ST Elevation Myocardial Infarction Clinical Trial

— BRIGHT-4  

Official title:

Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03822975
• Other study ID #: 2018-031
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2019
• Est. completion date: May 6, 2023

Study information

• Verified date: June 2022
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6016
• Est. completion date: May 6, 2023
• Est. primary completion date: May 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Bivalirudin
Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is <225 s (Hemotec method), intravenous injection of 0.35 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is >225 seconds.
• unfractionated Heparin
Heparin 70 U/kg is started before coronary angiography. ACT is monitored 5 min after the first administration, and if the ACT <225 s (Hemotec method), an intravenous injection of 1000 U of heparin is administered, and the ACT re-checked to ensure it is >225 seconds.

Locations

Country	Name	City	State
China	The People's Hospital Of Pingchang	Bazhong	Sichuan
China	Beijing Luhe Hospital.Capital Medical University	Beijing	Beijing
China	Peking University Third Hospital Yanqing Hospital	Beijing	Beijing
China	Bengbu Second People's Hospital	Bengbu	Anhui
China	General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group	Benxi	Liaoning
China	China-Japan Union Hospital of Jilin University	Chang chun	Jilin
China	The Second Hospital of Jilin University	Chang chun	Jilin
China	"West China Hospital Sichuan University"	Chengdu	Sichuan
China	Chengdu Second People'S Hospital	Chengdu	Sichuan
China	Hospital of Chengdu University of TCM	Chengdu	Sichuan
China	Chifeng College Affiliated Hospital	Chifeng	Inner Mongolia
China	Chongqing University Fuling Hospital	Chongqing	Chongqing
China	Dalian No.3 People'S Hospital	Dalian	Liaoning
China	Datong Third People'S Hospiatl	Datong	Shanxi
China	Jiangpiqiao99@sina.com	Diaobingshan	Liaoning
China	Fushun Central Hospital	Fushun	Liaoning
China	General Hospital of Fushun Mining Industry Group of Liaoning Health Industry Group	Fushun	Liaoning
China	General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group	Fuxin	Liaoning
China	Fu Yang People'S Hospital	Fuyang	Anhui
China	Linquan County Peoples Hospital	Fuyang	Anhui
China	NO.2 People's Hospital of Fuyang City	Fuyang	Anhui
China	Taihe County People'S Hospital	Fuyang	Anhui
China	First Affiliated Hospital Of Gannan Medical University	Ganzhou	Jiangxi
China	Ganzhou Municipal Hospital	Ganzhou	Jiangxi
China	Nan Fang Hospital.Ganzhou	Ganzhou	Jiangxi
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Zhejiang Provincial Hospital of Chinese Medicine	Hangzhou	Zhejiang
China	Bozhou Peoples Hospital	Haozhou	Anhui
China	Hengshuicardiovascularhospital	Hengshui	Hebei
China	Heze Mudan People's Hospital	Heze	Shandong
China	Heze Municipal Hospital	Heze	Shandong
China	Huainan Oriental Hospital Group Affiliated Hospital of Anhui University of Science & Technology	Huainan	Anhui
China	The First Hospital of Anhui University of Science&Technology	Huainan	Anhui
China	Jiaozuo People's Hospital	Jiaozuo	Henan
China	Jinan Central Hospital	Jinan	Shandong
China	Shandong Scend Provincial General Hosptial	Jinan	Shandong
China	The Fifth People's Hospital of Jinan	Jinan	Shandong
China	Kaifeng Central Hospital	Kaifeng	Henan
China	Yunnan St.John'S Hospital	Kunming	Yunnan
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Lou Di Central Hospital	Loudi	Hunan
China	Luohe Central Hospital	Luohe	Henan
China	The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University	Luzhou	Sichuan
China	Meizhou Peopie's Hospital	Meizhou	Guangdong
China	The Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	The Second Affiliated Hospital Of Nanchang University	Nanchang	Jiangxi
China	Thefirstaffiliated Hospitalofnanchang University	Nanchang	Jiangxi
China	Nanjing Firsthospital	Nanjing	Jiangsu
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	The First People'S Hospital of Ruzhou	Ruzhou	Henan
China	Shangqiu first people's Hospital	Shangqiu	Henan
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	The Fourth Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	The Second Hospital of Shen Yang Medical College	Shenyang	Liaoning
China	Suzhou Municipal Hospital	Suzhou	Anhui
China	Taian City Central Hospital	Tai'an	Shandong
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi
China	Jiangsutaizhou Peoples Hospital	Taizhou	Jiangsu
China	Taizhou Central Hospital	Taizhou	Zhejiang
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	The Fifth Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Itchoshtal Tonjinee Colere Hoatono Innehatyor Seene Ano Thohholdcy	Wuhan	Hubei
China	Tongji Hospital Tongji Medical College of Hust	Wuhan	Hubei
China	Wuhanasia Heart Hospital	Wuhan	Hubei
China	Department of Cardiology, Tangdu Hospital, Airforce Medical University	Xi'an	Shanxi
China	The Amliated HospitalofNorthwest University Xi'an No.3 Hospital	Xi'an	Shanxi
China	The Second Affiliated Hospital Of Xian Jiaotong University	Xi'an	Shanxi
China	Xiangtan Central Hospital	Xiangtan	Hunan
China	The First Hospital of Liangshan	Xichang	Sichaun
China	Xi Chang People'S Hospital	Xichang	Sichuan
China	The People's Hospital ofXin Tai City	Xintai	Shandong
China	The Third Affiliated Hospital Of Xinxiang Medical University	Xinxiang	Henan
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	Yan 'an university Affiliated Hospital	Yanan	Shanxi
China	Yanbian University Hospital	Yanbian	Jilin
China	Yueyang Central Hospital	Yueyang	Hunan
China	Yulin First People's Hospital	Yulin	Guangxi
China	Yuzhoucitypeopleshospital	Yuzhou	Henan
China	Zao Zhuang Central Hospital Of Shandong Guoxin Healthcare Group	Zaozhuang	Shandong
China	Fuwai Central China Cardiovascular Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University Center 1	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University Center 2	Zhengzhou	Henan
China	The First People'S Hospital of Xinmi	Zhengzhou	Henan
China	Affiliated Hospital Ofzunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause death or BARC type 3~5 bleeding	BARC=Bleeding academic research consortium	30 days
Secondary	All cause mortality		30 days
Secondary	BARC type 3-5 bleeding	BARC=Bleeding academic research consortium	30 days
Secondary	Major adverse cardiac and cerebral events (MACE)	MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization	30 days
Secondary	Net adverse clinical events (NACE)	NACE is defined as a composite of MACE or BARC type 3-5 bleeding	30 days
Secondary	Composite of all-cause death or BARC type 2-5 bleeding	BARC=Bleeding academic research consortium	30 days
Secondary	BARC type 2-5 bleeding	BARC=Bleeding academic research consortium	30 days
Secondary	Stent thrombosis	Definite or probable stent thrombosis according to Academic Research Consortium	30 days
Secondary	Thrombocytopenia	defined as platelet counts less than 150*10^9/L after treatment	30 days
Secondary	All cause mortality		1 years