BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.

Acute Myocardial Infarction Clinical Trial

— BRIGHT  

Official title:

Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696110
• Other study ID #: SYNH20120001
• Secondary ID: 2011BAI11B07
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2012
• Last updated: September 30, 2014
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: September 2014
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2194
• Est. completion date: July 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention

Intervention

Drug:
• Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
• heparin
heparin monotherapy
• heparin plus tirofiban
combined use of heparin and tirofiban during PCI

Locations

Country	Name	City	State
China	No.252 Hosp. of PLA	Baoding	Hebei
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	Beijing General Hosp. of PLA	Beijing	Beijing
China	Beijing Hosp.	Beijing	Beijing
China	Beijing Luhe Hosp.	Beijing	Beijing
China	General Hosp of PLA (1)	Beijing	Beijing
China	General Hosp. of PLA(2)	Beijing	Beijing
China	Navy General Hosp. of PLA	Beijing	Beijing
China	No.304 Hosp. of PLA	Beijing	Beijing
China	No.306 Hosp. of PLA	Beijing	Beijing
China	Peking Univ. First Hosp.	Beijing	Beijing
China	The 2nd artillery general Hosp. of PLA	Beijing	Beijing
China	Cangzhou Centeral Hosp.	Cangzhou	Hebei
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	Chengdu General Hosp. of PLA	Chengdu	Sichuan
China	Chengdu No.2 Hosp.	Chengdu	Sichuan
China	Chongqing Daping Hosp.	Chongqing	Chongqing
China	Dalian Zhongshan Hosp.	Dalian	Liaoning
China	No.210 Hosp of PLA	Dalian	Liaoning
China	Daqing General Hosp. of OF.	Daqing	Heilongjiang
China	Fujian Med Univ. Uion Hosp.	Fuzhou	Fujian
China	1 st Hosp. of Guangzhou MU	Guangzhou	Guangdong
China	1st Hosp. of Zhongshan MU	Guangzhou	Guangdong
China	Guangdong General Hosp.	Guangzhou	Guangdong
China	Guangzhou General Hosp. of PLA	Guangzhou	Guangdong
China	2nd Hosp. of Zhejiang Univ.	Hangzhou	Zhejiang
China	Zhejiang Hosp.	Hangzhou	Zhejiang
China	1 st Hosp. of Anhui Med Univ.	Hefei	Anhui
China	Anhui Provincial Hosp.	Hefei	Anhui
China	No.313 Hosp. of PLA	Huludao	Liaoning
China	Ji'nan General Hosp. of PLA	Ji'nan	Shandong
China	Affiliated Hosp. of Jining MC	Jining	Shandong
China	1st Hosp. of Liaoning MC	Jinzhou	Liaoning
China	3 rd Hosp. of Liaoning Med Col.	Jinzhou	Liaoning
China	Kunming General Hosp. of PLA	Kunming	Yunnan
China	1 st Hosp. of Lanzhou Univ.	Lanzhou	Gansu
China	Lanzhou General Hosp. of PLA	Lanzhou	Gansu
China	Meihekou Central Hosp.	Meihekou	Jilin
China	2 nd Hosp. of Nanchang Univ.	Nanchang	Jiangxi
China	Nanjing First Hosp.	Nanjing	Jiangsu
China	1 st Hosp. of Guangxi Med Univ.	Nanning	Guangxi
China	No.152 Hosp.	Pingdingshan	Henan
China	Qinhuangdao No.1 Hosp.	Qinhuangdao	Hebei
China	Huashan Hosp.	Shanghai	Shanghai
China	Shanghai jingan people's hosp.	Shanghai	Shanghai
China	Shanghai Renji Hosp.	Shanghai	Shanghai
China	No.463 Hosp of PLA	Shenyang	Liaoning
China	Shenzhou Hosp. of SMC	Shenyang	Liaoning
China	Hebei General Hosp.	Shijiazhuang	Hebei
China	Shijiazhuang Peace Hosp.	Shijiazhuang	Hebei
China	Taian Central Hosp.	Taian	Shandong
China	1st Hosp. of Shanxi Med Univ.	Taiyuan	Shanxi
China	Shanxi Cardiovascular Hosp.	Taiyuan	Shanxi
China	Taiyuan Central Hosp.	Taiyuan	Shanxi
China	Tangshan Gongren Hosp.	Tangshan	Hebei
China	No.254 Hosp. of PLA	Tianjin	Tianjin
China	Tianjin CAPF Hosp.	Tianjin	Tianjin
China	Tianjin Chest Hosp.	Tianjin	Tianjin
China	Tianjin No.3 Hosp.	Tianjin	Tianjin
China	Tianjin People's Hosp.	Tianjin	Tianjin
China	Wuhan Asican Heart Hosp.	Wuhan	Hubei
China	Wuhan General Hosp of PLA	Wuhan	Hubei
China	2 nd Hosp. of Xi'an Med Col.	Xi'an	Shanxi
China	Shanxi General Hosp.	Xi'an	Shanxi
China	Shanxi General Hosp. of CAPF	Xi'an	Shanxi
China	Tangdu Hosp.	Xi'an	Shanxi
China	Xijing Hosp.	Xi'an	Shanxi
China	Xuzhou Med Col. Affiliated Hosp.	Xuzhou	Jiangsu
China	Xuzhou No.4 Hosp.	Xuzhou	Jiangsu
China	Yanan Univ. affiliated Hosp.	Yanan	Shanxi
China	Yantaishan Hosp.	Yantai	Shandong
China	General Hosp. of Ningxia MU	Yinchuan	Ningxia
China	Yingkou Centeral Hosp.	Yingkou	Liaoning
China	Yuncheng Central Hosp.	Yuncheng	Shanxi
China	No. 148 Hosp.	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	stent thrombosis	by ARC definition	30 days and 1 year	Yes
Primary	Net Adverse Clinical Events	A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings	30 days	No
Secondary	Net adverse clinical events	a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings	1 year	No
Secondary	any bleedings (BARC class)	including all BARC class (class 1-5)	30 day	Yes
Secondary	Major adverse cardiac and cerebral events (MACCE)	a composite of all cause death, reinfarction, target vessel revascularization or stroke	30 days and 1 year	No