Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI
BRIGHT-4
1 other identifier
interventional
6,016
1 country
85
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
February 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2023
CompletedAugust 27, 2025
August 1, 2025
3.2 years
January 29, 2019
August 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of all-cause death or BARC type 3~5 bleeding
BARC=Bleeding academic research consortium
30 days
Secondary Outcomes (9)
All cause mortality
30 days
BARC type 3-5 bleeding
30 days
Major adverse cardiac and cerebral events (MACE)
30 days
Net adverse clinical events (NACE)
30 days
Composite of all-cause death or BARC type 2-5 bleeding
30 days
- +4 more secondary outcomes
Study Arms (2)
Bivalirudin
EXPERIMENTALBivalirudin with prolonged full dose infusion during primary PCI
Heparin
ACTIVE COMPARATORHeparin alone during primary PCI
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
Bengbu Second People's Hospital
Bengbu, Anhui, 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
Bozhou Peoples Hospital
Haozhou, Anhui, 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
Suzhou Municipal Hospital
Suzhou, Anhui, China
Beijing Luhe Hospital.Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital Yanqing Hospital
Beijing, Beijing Municipality, China
Chongqing University Fuling Hospital
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Meizhou Peopie's Hospital
Meizhou, Guangdong, China
Yulin First People's Hospital
Yulin, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital Ofzunyi Medical University
Zunyi, Guizhou, China
Hengshuicardiovascularhospital
Hengshui, Hebei, China
Jiaozuo People's Hospital
Jiaozuo, Henan, China
Kaifeng Central Hospital
Kaifeng, Henan, China
Luohe Central Hospital
Luohe, Henan, China
The First People'S Hospital of Ruzhou
Ruzhou, Henan, China
Shangqiu first people's Hospital
Shangqiu, Henan, China
The Third Affiliated Hospital Of Xinxiang Medical University
Xinxiang, Henan, China
Yuzhoucitypeopleshospital
Yingchuan, Henan, 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
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
Lou Di Central Hospital
Loudi, Hunan, China
Xiangtan Central Hospital
Xiangtan, Hunan, China
Yueyang Central Hospital
Yueyang, Hunan, China
Chifeng College Affiliated Hospital
Chifeng, Inner Mongolia, China
Nanjing Firsthospital
Nanjing, Jiangsu, China
Jiangsutaizhou Peoples Hospital
Taizhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 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 Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Thefirstaffiliated Hospitalofnanchang University
Nanchang, Jiangxi, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Yanbian University Hospital
Yanbian, Jilin, China
General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group
Benxi, Liaoning, China
Dalian No.3 People'S Hospital
Dalian, Liaoning, China
Jiangpiqiao99@sina.com
Diaobingshancun, 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
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
Heze Mudan People's Hospital
Heze, Shandong, China
Heze Municipal Hospital
Heze, Shandong, 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
Qingdao Municipal Hospital
Qingdao, Shandong, China
Taian City Central Hospital
Tai’an, Shandong, China
The People's Hospital ofXin Tai City
Xintai, Shandong, China
Zao Zhuang Central Hospital Of Shandong Guoxin Healthcare Group
Zaozhuang, Shandong, China
Datong Third People'S Hospiatl
Datong, Shanxi, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 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
Yan 'an university Affiliated Hospital
Yanan, Shanxi, China
The First Hospital of Liangshan
Xichang, Sichaun, China
The People's Hospital Of Pingchang
Bazhong City, Sichuan, 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
The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
Luzhou, Sichuan, China
Xi Chang People'S Hospital
Xichang, Sichuan, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Fifth Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Yunnan St.John'S Hospital
Kunming, Yunnan, China
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
Related Publications (4)
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.
PMID: 36351459BACKGROUNDZhang D, Li Y, Qiu M, Liang Z, Xu K, Li Y, Zhang G, Xie W, Zeng H, Cheng Y, Liu J, Cheng X, Zeng Q, Zhu K, Hu J, Cheng K, Wang J, Cheng R, Zhou Y, Wang B, Cao G, Han Y, Stone GW. BMI differences on anticoagulation with bivalirudin vs. heparin during primary PCI: a BRIGHT-4 subanalysis. BMC Med. 2025 Sep 30;23(1):525. doi: 10.1186/s12916-025-04374-7.
PMID: 41029353DERIVEDSu X, Qiu M, Gu C, Yang X, Liu B, Meng F, Ning B, Li W, Zhong Z, Wang Z, Shi B, Shang Z, Liang Z, Li Y, Han Y, Stone GW. Analysis of inter-hospital transfer on clinical outcomes after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: A secondary analysis of the BRIGHT-4 trial. PLoS Med. 2025 Jul 23;22(7):e1004679. doi: 10.1371/journal.pmed.1004679. eCollection 2025 Jul.
PMID: 40700454DERIVEDLiao J, Qiu M, Feng X, Chen K, Zhang D, Zou Y, Zheng X, Zhao G, Tian N, Zheng Z, Peng X, Yang Q, Liang Z, Li Y, Han Y, Stone GW. Bivalirudin versus heparin in patients with or without bail-out GPI use: a pre-specified subgroup analysis from the BRIGHT-4 trial. BMC Med. 2024 Sep 27;22(1):410. doi: 10.1186/s12916-024-03579-6.
PMID: 39334129DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaling Han, MD
The General Hospital of Northern Theater Command
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
January 29, 2019
First Posted
January 30, 2019
Study Start
February 14, 2019
Primary Completion
May 7, 2022
Study Completion
May 6, 2023
Last Updated
August 27, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share