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Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI (BRIGHT-4)

Primary Purpose

ST Elevation Myocardial Infarction

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bivalirudin
unfractionated Heparin
Sponsored by
Shenyang Northern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring Primary percutaneous coronary intervention, anticoagulant agents, bivalirudin, heparin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any age;
  • STEMI patients undergoing primary PCI with ST elevation≥1mm in≥2 contiguous leads or new LBBB with symptom onset 48h;
  • Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin);
  • Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor);
  • The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent.

Exclusion Criteria:

  • Not suitable for emergency primary PCI;
  • STEMI treated by thrombolysis;
  • Patients received heparin, LMWH, fondaparinux, bivalirudin, or GPI within 48 hours before the index PCI;
  • Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);
  • Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor
  • Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study).

Sites / Locations

  • Bengbu Second People's Hospital
  • Fu Yang People'S Hospital
  • Linquan County Peoples Hospital
  • NO.2 People's Hospital of Fuyang City
  • Taihe County People'S Hospital
  • Bozhou Peoples Hospital
  • Huainan Oriental Hospital Group Affiliated Hospital of Anhui University of Science & Technology
  • The First Hospital of Anhui University of Science&Technology
  • Suzhou Municipal Hospital
  • Beijing Luhe Hospital.Capital Medical University
  • Peking University Third Hospital Yanqing Hospital
  • Chongqing University Fuling Hospital
  • The First Hospital of Lanzhou University
  • Meizhou Peopie's Hospital
  • Yulin First People's Hospital
  • The Affiliated Hospital of Guizhou Medical University
  • Affiliated Hospital Ofzunyi Medical University
  • Hengshuicardiovascularhospital
  • Jiaozuo People's Hospital
  • Kaifeng Central Hospital
  • Luohe Central Hospital
  • The First People'S Hospital of Ruzhou
  • Shangqiu first people's Hospital
  • The Third Affiliated Hospital Of Xinxiang Medical University
  • Yuzhoucitypeopleshospital
  • Fuwai Central China Cardiovascular Hospital
  • The First Affiliated Hospital of Zhengzhou University Center 1
  • The First Affiliated Hospital of Zhengzhou University Center 2
  • The First People'S Hospital of Xinmi
  • Itchoshtal Tonjinee Colere Hoatono Innehatyor Seene Ano Thohholdcy
  • Tongji Hospital Tongji Medical College of Hust
  • Wuhanasia Heart Hospital
  • Lou Di Central Hospital
  • Xiangtan Central Hospital
  • Yueyang Central Hospital
  • Chifeng College Affiliated Hospital
  • Nanjing Firsthospital
  • Jiangsutaizhou Peoples Hospital
  • Xuzhou Central Hospital
  • First Affiliated Hospital Of Gannan Medical University
  • Ganzhou Municipal Hospital
  • Nan Fang Hospital.Ganzhou
  • The Jiangxi Provincial People's Hospital
  • The Second Affiliated Hospital Of Nanchang University
  • Thefirstaffiliated Hospitalofnanchang University
  • China-Japan Union Hospital of Jilin University
  • The Second Hospital of Jilin University
  • Yanbian University Hospital
  • General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group
  • Dalian No.3 People'S Hospital
  • Jiangpiqiao99@sina.com
  • Fushun Central Hospital
  • General Hospital of Fushun Mining Industry Group of Liaoning Health Industry Group
  • General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
  • General Hospital of Northern Theater Command
  • The Fourth Affiliated Hospital of China Medical University
  • The Second Hospital of Shen Yang Medical College
  • Heze Mudan People's Hospital
  • Heze Municipal Hospital
  • Jinan Central Hospital
  • Shandong Scend Provincial General Hosptial
  • The Fifth People's Hospital of Jinan
  • Qingdao Municipal Hospital
  • Taian City Central Hospital
  • The People's Hospital ofXin Tai City
  • Zao Zhuang Central Hospital Of Shandong Guoxin Healthcare Group
  • Datong Third People'S Hospiatl
  • Shanxi Cardiovascular Hospital
  • Department of Cardiology, Tangdu Hospital, Airforce Medical University
  • The Amliated HospitalofNorthwest University Xi'an No.3 Hospital
  • The Second Affiliated Hospital Of Xian Jiaotong University
  • Yan 'an university Affiliated Hospital
  • The First Hospital of Liangshan
  • The People's Hospital Of Pingchang
  • "West China Hospital Sichuan University"
  • Chengdu Second People'S Hospital
  • Hospital of Chengdu University of TCM
  • The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
  • Xi Chang People'S Hospital
  • Tianjin Chest Hospital
  • Tianjin Medical University General Hospital
  • The Fifth Affiliated Hospital of Xinjiang Medical University
  • Yunnan St.John'S Hospital
  • Zhejiang Provincial Hospital of Chinese Medicine
  • Taizhou Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bivalirudin

Heparin

Arm Description

Bivalirudin with prolonged full dose infusion during primary PCI

Heparin alone during primary PCI

Outcomes

Primary Outcome Measures

Composite of all-cause death or BARC type 3~5 bleeding
BARC=Bleeding academic research consortium

Secondary Outcome Measures

All cause mortality
BARC type 3-5 bleeding
BARC=Bleeding academic research consortium
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
Net adverse clinical events (NACE)
NACE is defined as a composite of MACE or BARC type 3-5 bleeding
Composite of all-cause death or BARC type 2-5 bleeding
BARC=Bleeding academic research consortium
BARC type 2-5 bleeding
BARC=Bleeding academic research consortium
Stent thrombosis
Definite or probable stent thrombosis according to Academic Research Consortium
Thrombocytopenia
defined as platelet counts less than 150*10^9/L after treatment
All cause mortality

Full Information

First Posted
January 29, 2019
Last Updated
June 9, 2022
Sponsor
Shenyang Northern Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03822975
Brief Title
Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI
Acronym
BRIGHT-4
Official Title
Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
May 7, 2022 (Actual)
Study Completion Date
May 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenyang Northern Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
Primary percutaneous coronary intervention, anticoagulant agents, bivalirudin, heparin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6016 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bivalirudin
Arm Type
Experimental
Arm Description
Bivalirudin with prolonged full dose infusion during primary PCI
Arm Title
Heparin
Arm Type
Active Comparator
Arm Description
Heparin alone during primary PCI
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
unfractionated Heparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite of all-cause death or BARC type 3~5 bleeding
Description
BARC=Bleeding academic research consortium
Time Frame
30 days
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
30 days
Title
BARC type 3-5 bleeding
Description
BARC=Bleeding academic research consortium
Time Frame
30 days
Title
Major adverse cardiac and cerebral events (MACE)
Description
MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization
Time Frame
30 days
Title
Net adverse clinical events (NACE)
Description
NACE is defined as a composite of MACE or BARC type 3-5 bleeding
Time Frame
30 days
Title
Composite of all-cause death or BARC type 2-5 bleeding
Description
BARC=Bleeding academic research consortium
Time Frame
30 days
Title
BARC type 2-5 bleeding
Description
BARC=Bleeding academic research consortium
Time Frame
30 days
Title
Stent thrombosis
Description
Definite or probable stent thrombosis according to Academic Research Consortium
Time Frame
30 days
Title
Thrombocytopenia
Description
defined as platelet counts less than 150*10^9/L after treatment
Time Frame
30 days
Title
All cause mortality
Time Frame
1 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any age; STEMI patients undergoing primary PCI with ST elevation≥1mm in≥2 contiguous leads or new LBBB with symptom onset 48h; Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin); Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor); The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent. Exclusion Criteria: Not suitable for emergency primary PCI; STEMI treated by thrombolysis; Patients received heparin, LMWH, fondaparinux, bivalirudin, or GPI within 48 hours before the index PCI; Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.); Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, MD
Organizational Affiliation
The General Hospital of Northern Theater Command
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bengbu Second People's Hospital
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
Fu Yang People'S Hospital
City
Fuyang
State/Province
Anhui
Country
China
Facility Name
Linquan County Peoples Hospital
City
Fuyang
State/Province
Anhui
Country
China
Facility Name
NO.2 People's Hospital of Fuyang City
City
Fuyang
State/Province
Anhui
Country
China
Facility Name
Taihe County People'S Hospital
City
Fuyang
State/Province
Anhui
Country
China
Facility Name
Bozhou Peoples Hospital
City
Haozhou
State/Province
Anhui
Country
China
Facility Name
Huainan Oriental Hospital Group Affiliated Hospital of Anhui University of Science & Technology
City
Huainan
State/Province
Anhui
Country
China
Facility Name
The First Hospital of Anhui University of Science&Technology
City
Huainan
State/Province
Anhui
Country
China
Facility Name
Suzhou Municipal Hospital
City
Suzhou
State/Province
Anhui
Country
China
Facility Name
Beijing Luhe Hospital.Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Third Hospital Yanqing Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chongqing University Fuling Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
Meizhou Peopie's Hospital
City
Meizhou
State/Province
Guangdong
Country
China
Facility Name
Yulin First People's Hospital
City
Yulin
State/Province
Guangxi
Country
China
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
Affiliated Hospital Ofzunyi Medical University
City
Zunyi
State/Province
Guizhou
Country
China
Facility Name
Hengshuicardiovascularhospital
City
Hengshui
State/Province
Hebei
Country
China
Facility Name
Jiaozuo People's Hospital
City
Jiaozuo
State/Province
Henan
Country
China
Facility Name
Kaifeng Central Hospital
City
Kaifeng
State/Province
Henan
Country
China
Facility Name
Luohe Central Hospital
City
Luohe
State/Province
Henan
Country
China
Facility Name
The First People'S Hospital of Ruzhou
City
Ruzhou
State/Province
Henan
Country
China
Facility Name
Shangqiu first people's Hospital
City
Shangqiu
State/Province
Henan
Country
China
Facility Name
The Third Affiliated Hospital Of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
Country
China
Facility Name
Yuzhoucitypeopleshospital
City
Yuzhou
State/Province
Henan
Country
China
Facility Name
Fuwai Central China Cardiovascular Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University Center 1
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University Center 2
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The First People'S Hospital of Xinmi
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Itchoshtal Tonjinee Colere Hoatono Innehatyor Seene Ano Thohholdcy
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Tongji Hospital Tongji Medical College of Hust
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Wuhanasia Heart Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Lou Di Central Hospital
City
Loudi
State/Province
Hunan
Country
China
Facility Name
Xiangtan Central Hospital
City
Xiangtan
State/Province
Hunan
Country
China
Facility Name
Yueyang Central Hospital
City
Yueyang
State/Province
Hunan
Country
China
Facility Name
Chifeng College Affiliated Hospital
City
Chifeng
State/Province
Inner Mongolia
Country
China
Facility Name
Nanjing Firsthospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Jiangsutaizhou Peoples Hospital
City
Taizhou
State/Province
Jiangsu
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
First Affiliated Hospital Of Gannan Medical University
City
Ganzhou
State/Province
Jiangxi
Country
China
Facility Name
Ganzhou Municipal Hospital
City
Ganzhou
State/Province
Jiangxi
Country
China
Facility Name
Nan Fang Hospital.Ganzhou
City
Ganzhou
State/Province
Jiangxi
Country
China
Facility Name
The Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The Second Affiliated Hospital Of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Thefirstaffiliated Hospitalofnanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
China-Japan Union Hospital of Jilin University
City
Chang chun
State/Province
Jilin
Country
China
Facility Name
The Second Hospital of Jilin University
City
Chang chun
State/Province
Jilin
Country
China
Facility Name
Yanbian University Hospital
City
Yanbian
State/Province
Jilin
Country
China
Facility Name
General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group
City
Benxi
State/Province
Liaoning
Country
China
Facility Name
Dalian No.3 People'S Hospital
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Jiangpiqiao99@sina.com
City
Diaobingshan
State/Province
Liaoning
Country
China
Facility Name
Fushun Central Hospital
City
Fushun
State/Province
Liaoning
Country
China
Facility Name
General Hospital of Fushun Mining Industry Group of Liaoning Health Industry Group
City
Fushun
State/Province
Liaoning
Country
China
Facility Name
General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
City
Fuxin
State/Province
Liaoning
Country
China
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
The Fourth Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
The Second Hospital of Shen Yang Medical College
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Heze Mudan People's Hospital
City
Heze
State/Province
Shandong
Country
China
Facility Name
Heze Municipal Hospital
City
Heze
State/Province
Shandong
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Shandong Scend Provincial General Hosptial
City
Jinan
State/Province
Shandong
Country
China
Facility Name
The Fifth People's Hospital of Jinan
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Taian City Central Hospital
City
Tai'an
State/Province
Shandong
Country
China
Facility Name
The People's Hospital ofXin Tai City
City
Xintai
State/Province
Shandong
Country
China
Facility Name
Zao Zhuang Central Hospital Of Shandong Guoxin Healthcare Group
City
Zaozhuang
State/Province
Shandong
Country
China
Facility Name
Datong Third People'S Hospiatl
City
Datong
State/Province
Shanxi
Country
China
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Department of Cardiology, Tangdu Hospital, Airforce Medical University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
The Amliated HospitalofNorthwest University Xi'an No.3 Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
The Second Affiliated Hospital Of Xian Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Yan 'an university Affiliated Hospital
City
Yanan
State/Province
Shanxi
Country
China
Facility Name
The First Hospital of Liangshan
City
Xichang
State/Province
Sichaun
Country
China
Facility Name
The People's Hospital Of Pingchang
City
Bazhong
State/Province
Sichuan
Country
China
Facility Name
"West China Hospital Sichuan University"
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Chengdu Second People'S Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Hospital of Chengdu University of TCM
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
City
Luzhou
State/Province
Sichuan
Country
China
Facility Name
Xi Chang People'S Hospital
City
Xichang
State/Province
Sichuan
Country
China
Facility Name
Tianjin Chest Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The Fifth Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
Country
China
Facility Name
Yunnan St.John'S Hospital
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Zhejiang Provincial Hospital of Chinese Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Taizhou Central Hospital
City
Taizhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36351459
Citation
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.
Results Reference
derived

Learn more about this trial

Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI

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