Clinical trial NCT01696110: BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.
Official title: Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Percutaneous Coronary Intervention
Keywords: Bivalirudin
Acute myocardial infarction
percutaneous transluminal coronary angioplasty
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 2194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 80 years old
2. Planned emergency PCI for acute myocardial infarction (STEMI or NSTEMI) Symptom onset within 12h for STEMI (or within 24 h for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB) Symptom onset within 72h for NSTEMI
3. Avoid to undergoing revascularization for non-culprit vessels within 30 days after index procedure.
4. Provide written informed consent.

Exclusion Criteria:

1. Unsuitable for PCI; treatment by thrombolysis within 72 hours of acute ST-elevation myocardial infarction; left main coronary artery disease; cardiogenic shock.
2. Any anticoagulant agents were used 48 h before randomization.
3. Active bleeding or bleeding constitution, bleeding tendency, including the recent retina or vitreous hemorrhage (1 months), GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc.;
4. Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.),
5. Deep puncture or major surgery (including eye or brain surgery) within 1 month.
6. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
7. Untreated or uncontrolled hypertension \> 180/110 mmHg.
8. Hemoglobin \< 100 g/L or platelet count \< 100 \* 109 / L.
9. Elevated AST, ALT level higher than three times of the normal upper limit.
10. severe renal insufficiency (eGFR \< 30 mL/min / 1.73 m2).
11. Heparin induced thrombocytopenia.
12. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
13. Pregnancy or lactation.
14. Researchers think that doesn't fit to participate in this study.

Primary outcomes:
measure: Net Adverse Clinical Events
timeFrame: 30 days
Secondary outcomes:
measure: Net adverse clinical events
timeFrame: 1 year
measure: any bleedings (BARC class)
timeFrame: 30 day
measure: Major adverse cardiac and cerebral events (MACCE)
timeFrame: 30 days and 1 year
Other outcomes:
measure: Thrombocytopenia
timeFrame: 30 days
measure: stent thrombosis
timeFrame: 30 days and 1 year
Locations:
city: Hefei
country: China
facility: 1 st Hosp. of Anhui Med Univ.
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hosp.
state: Anhui
city: Beijing
country: China
facility: 3rd Hosp. of Beijing Univ.
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hosp.
state: Beijing
city: Beijing
country: China
facility: Beijing CAPF General Hosp.
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hosp.
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hosp.
state: Beijing
city: Beijing
country: China
facility: Beijing General Hosp. of PLA
state: Beijing
city: Beijing
country: China
facility: Beijing Hosp.
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hosp.
state: Beijing
city: Beijing
country: China
facility: General Hosp of PLA (1)
state: Beijing
city: Beijing
country: China
facility: General Hosp. of PLA(2)
state: Beijing
city: Beijing
country: China
facility: Navy General Hosp. of PLA
state: Beijing
city: Beijing
country: China
facility: No.304 Hosp. of PLA
state: Beijing
city: Beijing
country: China
facility: No.306 Hosp. of PLA
state: Beijing
city: Beijing
country: China
facility: Peking Univ. First Hosp.
state: Beijing
city: Beijing
country: China
facility: The 2nd artillery general Hosp. of PLA
state: Beijing
city: Chongqing
country: China
facility: Chongqing Daping Hosp.
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Med Univ. Uion Hosp.
state: Fujian
city: Lanzhou
country: China
facility: 1 st Hosp. of Lanzhou Univ.
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou General Hosp. of PLA
state: Gansu
city: Guangzhou
country: China
facility: 1 st Hosp. of Guangzhou MU
state: Guangdong
city: Guangzhou
country: China
facility: 1st Hosp. of Zhongshan MU
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong General Hosp.
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou General Hosp. of PLA
state: Guangdong
city: Nanning
country: China
facility: 1 st Hosp. of Guangxi Med Univ.
state: Guangxi
city: Baoding
country: China
facility: No.252 Hosp. of PLA
state: Hebei
city: Cangzhou
country: China
facility: Cangzhou Centeral Hosp.
state: Hebei
city: Qinhuangdao
country: China
facility: Qinhuangdao No.1 Hosp.
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei General Hosp.
state: Hebei
city: Shijiazhuang
country: China
facility: Shijiazhuang Peace Hosp.
state: Hebei
city: Tangshan
country: China
facility: Tangshan Gongren Hosp.
state: Hebei
city: Daqing
country: China
facility: Daqing General Hosp. of OF.
state: Heilongjiang
city: Pingdingshan
country: China
facility: No.152 Hosp.
state: Henan
city: Wuhan
country: China
facility: Wuhan Asican Heart Hosp.
state: Hubei
city: Wuhan
country: China
facility: Wuhan General Hosp of PLA
state: Hubei
city: Nanjing
country: China
facility: Nanjing First Hosp.
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Med Col. Affiliated Hosp.
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou No.4 Hosp.
state: Jiangsu
city: Nanchang
country: China
facility: 2 nd Hosp. of Nanchang Univ.
state: Jiangxi
city: Changchun
country: China
facility: 1st Hosp of Jilin Univ.
state: Jilin
city: Changchun
country: China
facility: 2nd Hosp of Jilin Univ.
state: Jilin
city: Changchun
country: China
facility: 3rd Hosp of Jilin Univ.
state: Jilin
city: Meihekou
country: China
facility: Meihekou Central Hosp.
state: Jilin
city: Dalian
country: China
facility: Dalian Zhongshan Hosp.
state: Liaoning
city: Dalian
country: China
facility: No.210 Hosp of PLA
state: Liaoning
city: Huludao
country: China
facility: No.313 Hosp. of PLA
state: Liaoning
city: Jinzhou
country: China
facility: 1st Hosp. of Liaoning MC
state: Liaoning
city: Jinzhou
country: China
facility: 3 rd Hosp. of Liaoning Med Col.
state: Liaoning
city: Shenyang
country: China
facility: No.463 Hosp of PLA
state: Liaoning
city: Shenyang
country: China
facility: Shenzhou Hosp. of SMC
state: Liaoning
city: Yingkou
country: China
facility: Yingkou Centeral Hosp.
state: Liaoning
city: Yinchuan
country: China
facility: General Hosp. of Ningxia MU
state: Ningxia
city: Ji'nan
country: China
facility: Ji'nan General Hosp. of PLA
state: Shandong
city: Jining
country: China
facility: Affiliated Hosp. of Jining MC
state: Shandong
city: Taian
country: China
facility: Taian Central Hosp.
state: Shandong
city: Yantai
country: China
facility: Yantaishan Hosp.
state: Shandong
city: Zibo
country: China
facility: No. 148 Hosp.
state: Shandong
city: Shanghai
country: China
facility: Huashan Hosp.
state: Shanghai
city: Shanghai
country: China
facility: Shanghai jingan people's hosp.
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Renji Hosp.
state: Shanghai
city: Taiyuan
country: China
facility: 1st Hosp. of Shanxi Med Univ.
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hosp.
state: Shanxi
city: Taiyuan
country: China
facility: Taiyuan Central Hosp.
state: Shanxi
city: Xi'an
country: China
facility: 2 nd Hosp. of Xi'an Med Col.
state: Shanxi
city: Xi'an
country: China
facility: Shanxi General Hosp. of CAPF
state: Shanxi
city: Xi'an
country: China
facility: Shanxi General Hosp.
state: Shanxi
city: Xi'an
country: China
facility: Tangdu Hosp.
state: Shanxi
city: Xi'an
country: China
facility: Xijing Hosp.
state: Shanxi
city: Yanan
country: China
facility: Yanan Univ. affiliated Hosp.
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hosp.
state: Shanxi
city: Chengdu
country: China
facility: Chengdu General Hosp. of PLA
state: Sichuan
city: Chengdu
country: China
facility: Chengdu No.2 Hosp.
state: Sichuan
city: Tianjin
country: China
facility: No.254 Hosp. of PLA
state: Tianjin
city: Tianjin
country: China
facility: Tianjin CAPF Hosp.
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Chest Hosp.
state: Tianjin
city: Tianjin
country: China
facility: Tianjin No.3 Hosp.
state: Tianjin
city: Tianjin
country: China
facility: Tianjin People's Hosp.
state: Tianjin
city: Kunming
country: China
facility: Kunming General Hosp. of PLA
state: Yunnan
city: Hangzhou
country: China
facility: 2nd Hosp. of Zhejiang Univ.
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Hosp.
state: Zhejiang
Study officials:
affiliation: Shenyang Northern Hospital,China
name: Yaling Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.