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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivalirudin | Experimental | Bivalirudin with prolonged full dose infusion during primary PCI |
|
| Heparin | Active Comparator | Heparin alone during primary PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause death or BARC type 3~5 bleeding | BARC=Bleeding academic research consortium | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 30 days | |
| BARC type 3-5 bleeding | BARC=Bleeding academic research consortium | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaling Han, MD | The General Hospital of Northern Theater Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bengbu Second People's Hospital | Bengbu | Anhui | China | |||
| Fu Yang People'S Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36351459 | Result | 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. | |
| 41029353 |
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|
| unfractionated Heparin | Drug | 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. |
|
| 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 |
| Net adverse clinical events (NACE) | NACE is defined as a composite of MACE or BARC type 3-5 bleeding | 30 days |
| Composite of all-cause death or BARC type 2-5 bleeding | BARC=Bleeding academic research consortium | 30 days |
| BARC type 2-5 bleeding | BARC=Bleeding academic research consortium | 30 days |
| Stent thrombosis | Definite or probable stent thrombosis according to Academic Research Consortium | 30 days |
| Thrombocytopenia | defined as platelet counts less than 150*10^9/L after treatment | 30 days |
| All cause mortality | 1 years |
| 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 | Yuzhou | 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 | 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 |
| Derived |
| Zhang 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. |
| 40700454 | Derived | Su 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. |
| 39334129 | Derived | Liao 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. |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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