BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.
- Conditions
- Percutaneous Coronary InterventionAcute Myocardial Infarction
- Interventions
- Registration Number
- NCT01696110
- Lead Sponsor
- Shenyang Northern Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2194
- Age 18 to 80 years old
- 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
- Avoid to undergoing revascularization for non-culprit vessels within 30 days after index procedure.
- Provide written informed consent.
- Unsuitable for PCI; treatment by thrombolysis within 72 hours of acute ST-elevation myocardial infarction; left main coronary artery disease; cardiogenic shock.
- Any anticoagulant agents were used 48 h before randomization.
- 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.;
- Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.),
- Deep puncture or major surgery (including eye or brain surgery) within 1 month.
- Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
- Untreated or uncontrolled hypertension > 180/110 mmHg.
- Hemoglobin < 100 g/L or platelet count < 100 * 109 / L.
- Elevated AST, ALT level higher than three times of the normal upper limit.
- severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2).
- Heparin induced thrombocytopenia.
- Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
- Pregnancy or lactation.
- Researchers think that doesn't fit to participate in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Heparin monotherapy heparin 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 heparin heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h. heparin plus tirofiban heparin plus tirofiban heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h. Bivalirudin Bivalirudin 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.
- Primary Outcome Measures
Name Time Method Net Adverse Clinical Events 30 days A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
- Secondary Outcome Measures
Name Time Method Major adverse cardiac and cerebral events (MACCE) 30 days and 1 year a composite of all cause death, reinfarction, target vessel revascularization or stroke
any bleedings (BARC class) 30 day including all BARC class (class 1-5)
Net adverse clinical events 1 year a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings
Trial Locations
- Locations (81)
1 st Hosp. of Anhui Med Univ.
🇨🇳Hefei, Anhui, China
Anhui Provincial Hosp.
🇨🇳Hefei, Anhui, China
3rd Hosp. of Beijing Univ.
🇨🇳Beijing, Beijing, China
Beijing Anzhen Hosp.
🇨🇳Beijing, Beijing, China
Beijing CAPF General Hosp.
🇨🇳Beijing, Beijing, China
Beijing Chaoyang Hosp.
🇨🇳Beijing, Beijing, China
Beijing Friendship Hosp.
🇨🇳Beijing, Beijing, China
General Hosp of PLA (1)
🇨🇳Beijing, Beijing, China
General Hosp. of PLA(2)
🇨🇳Beijing, Beijing, China
No.304 Hosp. of PLA
🇨🇳Beijing, Beijing, China
Chongqing Daping Hosp.
🇨🇳Chongqing, Chongqing, China
Peking Univ. First Hosp.
🇨🇳Beijing, Beijing, China
The 2nd artillery general Hosp. of PLA
🇨🇳Beijing, Beijing, China
1 st Hosp. of Lanzhou Univ.
🇨🇳Lanzhou, Gansu, China
Lanzhou General Hosp. of PLA
🇨🇳Lanzhou, Gansu, China
1st Hosp. of Zhongshan MU
🇨🇳Guangzhou, Guangdong, China
Guangdong General Hosp.
🇨🇳Guangzhou, Guangdong, China
Guangzhou General Hosp. of PLA
🇨🇳Guangzhou, Guangdong, China
1 st Hosp. of Guangxi Med Univ.
🇨🇳Nanning, Guangxi, China
No.252 Hosp. of PLA
🇨🇳Baoding, Hebei, China
Qinhuangdao No.1 Hosp.
🇨🇳Qinhuangdao, Hebei, China
Cangzhou Centeral Hosp.
🇨🇳Cangzhou, Hebei, China
Shijiazhuang Peace Hosp.
🇨🇳Shijiazhuang, Hebei, China
Daqing General Hosp. of OF.
🇨🇳Daqing, Heilongjiang, China
Tangshan Gongren Hosp.
🇨🇳Tangshan, Hebei, China
No.152 Hosp.
🇨🇳Pingdingshan, Henan, China
Wuhan Asican Heart Hosp.
🇨🇳Wuhan, Hubei, China
Xuzhou Med Col. Affiliated Hosp.
🇨🇳Xuzhou, Jiangsu, China
2 nd Hosp. of Nanchang Univ.
🇨🇳Nanchang, Jiangxi, China
1st Hosp of Jilin Univ.
🇨🇳Changchun, Jilin, China
2nd Hosp of Jilin Univ.
🇨🇳Changchun, Jilin, China
3rd Hosp of Jilin Univ.
🇨🇳Changchun, Jilin, China
Meihekou Central Hosp.
🇨🇳Meihekou, Jilin, China
Dalian Zhongshan Hosp.
🇨🇳Dalian, Liaoning, China
Shenzhou Hosp. of SMC
🇨🇳Shenyang, Liaoning, China
Ji'nan General Hosp. of PLA
🇨🇳Ji'nan, Shandong, China
Taian Central Hosp.
🇨🇳Taian, Shandong, China
Yantaishan Hosp.
🇨🇳Yantai, Shandong, China
No. 148 Hosp.
🇨🇳Zibo, Shandong, China
Shanghai jingan people's hosp.
🇨🇳Shanghai, Shanghai, China
Shanghai Renji Hosp.
🇨🇳Shanghai, Shanghai, China
Tangdu Hosp.
🇨🇳Xi'an, Shanxi, China
2 nd Hosp. of Xi'an Med Col.
🇨🇳Xi'an, Shanxi, China
Chengdu General Hosp. of PLA
🇨🇳Chengdu, Sichuan, China
Chengdu No.2 Hosp.
🇨🇳Chengdu, Sichuan, China
Tianjin CAPF Hosp.
🇨🇳Tianjin, Tianjin, China
Tianjin Chest Hosp.
🇨🇳Tianjin, Tianjin, China
Tianjin People's Hosp.
🇨🇳Tianjin, Tianjin, China
Kunming General Hosp. of PLA
🇨🇳Kunming, Yunnan, China
2nd Hosp. of Zhejiang Univ.
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Hosp.
🇨🇳Hangzhou, Zhejiang, China
Beijing General Hosp. of PLA
🇨🇳Beijing, Beijing, China
Beijing Hosp.
🇨🇳Beijing, Beijing, China
Beijing Luhe Hosp.
🇨🇳Beijing, Beijing, China
Navy General Hosp. of PLA
🇨🇳Beijing, Beijing, China
No.306 Hosp. of PLA
🇨🇳Beijing, Beijing, China
1 st Hosp. of Guangzhou MU
🇨🇳Guangzhou, Guangdong, China
Fujian Med Univ. Uion Hosp.
🇨🇳Fuzhou, Fujian, China
Hebei General Hosp.
🇨🇳Shijiazhuang, Hebei, China
Xuzhou No.4 Hosp.
🇨🇳Xuzhou, Jiangsu, China
Wuhan General Hosp of PLA
🇨🇳Wuhan, Hubei, China
Nanjing First Hosp.
🇨🇳Nanjing, Jiangsu, China
No.210 Hosp of PLA
🇨🇳Dalian, Liaoning, China
No.313 Hosp. of PLA
🇨🇳Huludao, Liaoning, China
1st Hosp. of Liaoning MC
🇨🇳Jinzhou, Liaoning, China
3 rd Hosp. of Liaoning Med Col.
🇨🇳Jinzhou, Liaoning, China
No.463 Hosp of PLA
🇨🇳Shenyang, Liaoning, China
Yingkou Centeral Hosp.
🇨🇳Yingkou, Liaoning, China
Affiliated Hosp. of Jining MC
🇨🇳Jining, Shandong, China
Huashan Hosp.
🇨🇳Shanghai, Shanghai, China
General Hosp. of Ningxia MU
🇨🇳Yinchuan, Ningxia, China
1st Hosp. of Shanxi Med Univ.
🇨🇳Taiyuan, Shanxi, China
Shanxi Cardiovascular Hosp.
🇨🇳Taiyuan, Shanxi, China
Taiyuan Central Hosp.
🇨🇳Taiyuan, Shanxi, China
Shanxi General Hosp. of CAPF
🇨🇳Xi'an, Shanxi, China
Shanxi General Hosp.
🇨🇳Xi'an, Shanxi, China
Xijing Hosp.
🇨🇳Xi'an, Shanxi, China
Yanan Univ. affiliated Hosp.
🇨🇳Yanan, Shanxi, China
No.254 Hosp. of PLA
🇨🇳Tianjin, Tianjin, China
Tianjin No.3 Hosp.
🇨🇳Tianjin, Tianjin, China
Yuncheng Central Hosp.
🇨🇳Yuncheng, Shanxi, China