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| ID | Type | Description | Link |
|---|---|---|---|
| 2011BAI11B07 | Other Grant/Funding Number | China National Science and Technology support project plan |
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The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor.
All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 2100 AMI patients undergoing percutaneous coronary intervention (PCI) to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor. All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivalirudin | Experimental | Bivalirudin will be started in the cath lab, 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; if ACT<225s 5min after bolus, an additional dose of 0.3mg/kg bolus should be given. After procedure, a prolonged infusion (1.75mg/kg per h) will be given for at least 30 min (totally no more than 4 h) followed by a reduced dose infusion (0.2mg/kg per h) up to 20 h. |
|
| Heparin monotherapy | Active Comparator | 100 IU/kg intravenous bolus. If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given. |
|
| heparin plus tirofiban | Active Comparator | heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net Adverse Clinical Events | A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Net adverse clinical events | a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings | 1 year |
| any bleedings (BARC class) | including all BARC class (class 1-5) |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombocytopenia | Defined as a decrease of platelet count of more than 50% or more than 150000 platelet/mm3 compared with baseline within 24h after study drug administration | 30 days |
| stent thrombosis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaling Han, MD | Shenyang Northern Hospital,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 st Hosp. of Anhui Med Univ. | Hefei | Anhui | 230000 | China | ||
| Anhui Provincial Hosp. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26762481 | Derived | Liang Z, Li Y, Wang J, Wang D, Wang S, Ma L, Liu H, Yang L, Stone GW, Han Y. The safety and effectiveness of bivalirudin in female patients with acute myocardial infarction undergoing primary angioplasty: A subgroup analysis of the BRIGHT trial. Catheter Cardiovasc Interv. 2016 Mar;87 Suppl 1:608-15. doi: 10.1002/ccd.26407. Epub 2016 Jan 13. | |
| 25775052 |
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| heparin | Drug | heparin monotherapy |
|
| heparin plus tirofiban | Drug | combined use of heparin and tirofiban during PCI |
|
|
| 30 day |
| Major adverse cardiac and cerebral events (MACCE) | a composite of all cause death, reinfarction, target vessel revascularization or stroke | 30 days and 1 year |
by ARC definition
| 30 days and 1 year |
| Hefei |
| Anhui |
| 230000 |
| China |
| 3rd Hosp. of Beijing Univ. | Beijing | Beijing Municipality | 100000 | China |
| Beijing Anzhen Hosp. | Beijing | Beijing Municipality | 100000 | China |
| Beijing CAPF General Hosp. | Beijing | Beijing Municipality | 100000 | China |
| Beijing Chaoyang Hosp. | Beijing | Beijing Municipality | 100000 | China |
| Beijing Friendship Hosp. | Beijing | Beijing Municipality | 100000 | China |
| Beijing General Hosp. of PLA | Beijing | Beijing Municipality | 100000 | China |
| Beijing Hosp. | Beijing | Beijing Municipality | 100000 | China |
| Beijing Luhe Hosp. | Beijing | Beijing Municipality | 100000 | China |
| General Hosp of PLA (1) | Beijing | Beijing Municipality | 100000 | China |
| General Hosp. of PLA(2) | Beijing | Beijing Municipality | 100000 | China |
| Navy General Hosp. of PLA | Beijing | Beijing Municipality | 100000 | China |
| No.304 Hosp. of PLA | Beijing | Beijing Municipality | 100000 | China |
| No.306 Hosp. of PLA | Beijing | Beijing Municipality | 100000 | China |
| Peking Univ. First Hosp. | Beijing | Beijing Municipality | 100000 | China |
| The 2nd artillery general Hosp. of PLA | Beijing | Beijing Municipality | 100000 | China |
| Chongqing Daping Hosp. | Chongqing | Chongqing Municipality | 400000 | China |
| Fujian Med Univ. Uion Hosp. | Fuzhou | Fujian | 350000 | China |
| 1 st Hosp. of Lanzhou Univ. | Lanzhou | Gansu | 730030 | China |
| Lanzhou General Hosp. of PLA | Lanzhou | Gansu | 730030 | China |
| 1 st Hosp. of Guangzhou MU | Guangzhou | Guangdong | 510000 | China |
| 1st Hosp. of Zhongshan MU | Guangzhou | Guangdong | 510000 | China |
| Guangdong General Hosp. | Guangzhou | Guangdong | 510000 | China |
| Guangzhou General Hosp. of PLA | Guangzhou | Guangdong | 510000 | China |
| 1 st Hosp. of Guangxi Med Univ. | Nanning | Guangxi | 210000 | China |
| No.252 Hosp. of PLA | Baoding | Hebei | 071000 | China |
| Cangzhou Centeral Hosp. | Cangzhou | Hebei | 061000 | China |
| Qinhuangdao No.1 Hosp. | Qinhuangdao | Hebei | 050000 | China |
| Hebei General Hosp. | Shijiazhuang | Hebei | 050000 | China |
| Shijiazhuang Peace Hosp. | Shijiazhuang | Hebei | 050000 | China |
| Tangshan Gongren Hosp. | Tangshan | Hebei | 063000 | China |
| Daqing General Hosp. of OF. | Daqing | Heilongjiang | 150000 | China |
| No.152 Hosp. | Pingdingshan | Henan | 467000 | China |
| Wuhan Asican Heart Hosp. | Wuhan | Hubei | 430000 | China |
| Wuhan General Hosp of PLA | Wuhan | Hubei | 430000 | China |
| Nanjing First Hosp. | Nanjing | Jiangsu | 210000 | China |
| Xuzhou Med Col. Affiliated Hosp. | Xuzhou | Jiangsu | 221000 | China |
| Xuzhou No.4 Hosp. | Xuzhou | Jiangsu | 221000 | China |
| 2 nd Hosp. of Nanchang Univ. | Nanchang | Jiangxi | 330000 | China |
| 1st Hosp of Jilin Univ. | Changchun | Jilin | 130000 | China |
| 2nd Hosp of Jilin Univ. | Changchun | Jilin | 130000 | China |
| 3rd Hosp of Jilin Univ. | Changchun | Jilin | 130000 | China |
| Meihekou Central Hosp. | Meihekou | Jilin | 135000 | China |
| Dalian Zhongshan Hosp. | Dalian | Liaoning | 116000 | China |
| No.210 Hosp of PLA | Dalian | Liaoning | 116000 | China |
| No.313 Hosp. of PLA | Huludao | Liaoning | 125000 | China |
| 1st Hosp. of Liaoning MC | Jinzhou | Liaoning | 121000 | China |
| 3 rd Hosp. of Liaoning Med Col. | Jinzhou | Liaoning | 121000 | China |
| No.463 Hosp of PLA | Shenyang | Liaoning | 110000 | China |
| Shenzhou Hosp. of SMC | Shenyang | Liaoning | 110000 | China |
| Yingkou Centeral Hosp. | Yingkou | Liaoning | 115000 | China |
| General Hosp. of Ningxia MU | Yinchuan | Ningxia | 750000 | China |
| Ji'nan General Hosp. of PLA | Ji'nan | Shandong | 250000 | China |
| Affiliated Hosp. of Jining MC | Jining | Shandong | 272000 | China |
| Taian Central Hosp. | Taian | Shandong | 271000 | China |
| Yantaishan Hosp. | Yantai | Shandong | 261400 | China |
| No. 148 Hosp. | Zibo | Shandong | 255000 | China |
| Huashan Hosp. | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai jingan people's hosp. | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai Renji Hosp. | Shanghai | Shanghai Municipality | 200000 | China |
| 1st Hosp. of Shanxi Med Univ. | Taiyuan | Shanxi | 030000 | China |
| Shanxi Cardiovascular Hosp. | Taiyuan | Shanxi | 030000 | China |
| Taiyuan Central Hosp. | Taiyuan | Shanxi | 030000 | China |
| 2 nd Hosp. of Xi'an Med Col. | Xi’an | Shanxi | 710000 | China |
| Shanxi General Hosp. of CAPF | Xi’an | Shanxi | 710000 | China |
| Shanxi General Hosp. | Xi’an | Shanxi | 710000 | China |
| Tangdu Hosp. | Xi’an | Shanxi | 710000 | China |
| Xijing Hosp. | Xi’an | Shanxi | 710000 | China |
| Yanan Univ. affiliated Hosp. | Yanan | Shanxi | 716000 | China |
| Yuncheng Central Hosp. | Yuncheng | Shanxi | 044000 | China |
| Chengdu General Hosp. of PLA | Chengdu | Sichuan | 610000 | China |
| Chengdu No.2 Hosp. | Chengdu | Sichuan | 610000 | China |
| No.254 Hosp. of PLA | Tianjin | Tianjin Municipality | 300000 | China |
| Tianjin CAPF Hosp. | Tianjin | Tianjin Municipality | 300000 | China |
| Tianjin Chest Hosp. | Tianjin | Tianjin Municipality | 300000 | China |
| Tianjin No.3 Hosp. | Tianjin | Tianjin Municipality | 300000 | China |
| Tianjin People's Hosp. | Tianjin | Tianjin Municipality | 300000 | China |
| Kunming General Hosp. of PLA | Kunming | Yunnan | 650000 | China |
| 2nd Hosp. of Zhejiang Univ. | Hangzhou | Zhejiang | 310000 | China |
| Zhejiang Hosp. | Hangzhou | Zhejiang | 310000 | China |
| Han Y, Guo J, Zheng Y, Zang H, Su X, Wang Y, Chen S, Jiang T, Yang P, Chen J, Jiang D, Jing Q, Liang Z, Liu H, Zhao X, Li J, Li Y, Xu B, Stone GW; BRIGHT Investigators. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1336-46. doi: 10.1001/jama.2015.2323. |
| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| D000077466 | Tirofiban |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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