AzTrials
AzTrials

ST Elevation Myocardial InfarctionBRIGHT-4NCT03822975

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

A study testing Bivalirudin and unfractionated Heparin in people with ST Elevation Myocardial Infarction, run by Shenyang Northern Hospital at 85 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
ST Elevation Myocardial Infarction
What is being tested?
Bivalirudin and unfractionated Heparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,016 participants
Where
85 sitesChina
Study dates
14 Feb 2019to 6 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

85 sites in 1 country.

85 sites in 1 country

China85 sites

  • The People's Hospital Of Pingchang

    Bazhong, Sichuan

  • Beijing Luhe Hospital.Capital Medical University

    Beijing, Beijing Municipality

  • Peking University Third Hospital Yanqing Hospital

    Beijing, Beijing Municipality

  • Bengbu Second People's Hospital

    Bengbu, Anhui

  • General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group

    Benxi, Liaoning

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • "West China Hospital Sichuan University"

    Chengdu, Sichuan

  • Chengdu Second People'S Hospital

    Chengdu, Sichuan

  • Hospital of Chengdu University of TCM

    Chengdu, Sichuan

  • Chifeng College Affiliated Hospital

    Chifeng, Inner Mongolia

  • Chongqing University Fuling Hospital

    Chongqing, Chongqing Municipality

  • Dalian No.3 People'S Hospital

    Dalian, Liaoning

  • Datong Third People'S Hospiatl

    Datong, Shanxi

  • Jiangpiqiao99@sina.com

    Diaobingshancun, Liaoning

  • Fushun Central Hospital

    Fushun, Liaoning

  • General Hospital of Fushun Mining Industry Group of Liaoning Health Industry Group

    Fushun, Liaoning

  • General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group

    Fuxin, Liaoning

  • Fu Yang People'S Hospital

    Fuyang, Anhui

  • Linquan County Peoples Hospital

    Fuyang, Anhui

  • NO.2 People's Hospital of Fuyang City

    Fuyang, Anhui

  • Taihe County People'S Hospital

    Fuyang, Anhui

  • First Affiliated Hospital Of Gannan Medical University

    Ganzhou, Jiangxi

  • Ganzhou Municipal Hospital

    Ganzhou, Jiangxi

  • Nan Fang Hospital.Ganzhou

    Ganzhou, Jiangxi

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • Zhejiang Provincial Hospital of Chinese Medicine

    Hangzhou, Zhejiang

  • Bozhou Peoples Hospital

    Haozhou, Anhui

  • Hengshuicardiovascularhospital

    Hengshui, Hebei

  • Heze Mudan People's Hospital

    Heze, Shandong

  • Heze Municipal Hospital

    Heze, Shandong

  • Huainan Oriental Hospital Group Affiliated Hospital of Anhui University of Science & Technology

    Huainan, Anhui

  • The First Hospital of Anhui University of Science&Technology

    Huainan, Anhui

  • Jiaozuo People's Hospital

    Jiaozuo, Henan

  • Jinan Central Hospital

    Jinan, Shandong

  • Shandong Scend Provincial General Hosptial

    Jinan, Shandong

  • The Fifth People's Hospital of Jinan

    Jinan, Shandong

  • Kaifeng Central Hospital

    Kaifeng, Henan

  • Yunnan St.John'S Hospital

    Kunming, Yunnan

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

  • Lou Di Central Hospital

    Loudi, Hunan

  • Luohe Central Hospital

    Luohe, Henan

  • The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University

    Luzhou, Sichuan

  • Meizhou Peopie's Hospital

    Meizhou, Guangdong

  • The Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

  • The Second Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi

  • Thefirstaffiliated Hospitalofnanchang University

    Nanchang, Jiangxi

  • Nanjing Firsthospital

    Nanjing, Jiangsu

  • Qingdao Municipal Hospital

    Qingdao, Shandong

  • The First People'S Hospital of Ruzhou

    Ruzhou, Henan

  • Shangqiu first people's Hospital

    Shangqiu, Henan

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang, Liaoning

  • The Second Hospital of Shen Yang Medical College

    Shenyang, Liaoning

  • Suzhou Municipal Hospital

    Suzhou, Anhui

  • Taian City Central Hospital

    Tai’an, Shandong

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi

  • Jiangsutaizhou Peoples Hospital

    Taizhou, Jiangsu

  • Taizhou Central Hospital

    Taizhou, Zhejiang

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • The Fifth Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • Itchoshtal Tonjinee Colere Hoatono Innehatyor Seene Ano Thohholdcy

    Wuhan, Hubei

  • Tongji Hospital Tongji Medical College of Hust

    Wuhan, Hubei

  • Wuhanasia Heart Hospital

    Wuhan, Hubei

  • Department of Cardiology, Tangdu Hospital, Airforce Medical University

    Xi’an, Shanxi

  • The Amliated HospitalofNorthwest University Xi'an No.3 Hospital

    Xi’an, Shanxi

  • The Second Affiliated Hospital Of Xian Jiaotong University

    Xi’an, Shanxi

  • Xiangtan Central Hospital

    Xiangtan, Hunan

  • The First Hospital of Liangshan

    Xichang, Sichaun

  • Xi Chang People'S Hospital

    Xichang, Sichuan

  • The People's Hospital ofXin Tai City

    Xintai, Shandong

  • The Third Affiliated Hospital Of Xinxiang Medical University

    Xinxiang, Henan

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

  • Yan 'an university Affiliated Hospital

    Yanan, Shanxi

  • Yanbian University Hospital

    Yanbian, Jilin

  • Yueyang Central Hospital

    Yueyang, Hunan

  • Yulin First People's Hospital

    Yulin, Guangxi

  • Yuzhoucitypeopleshospital

    Yuzhou, Henan

  • Zao Zhuang Central Hospital Of Shandong Guoxin Healthcare Group

    Zaozhuang, Shandong

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University Center 1

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University Center 2

    Zhengzhou, Henan

  • The First People'S Hospital of Xinmi

    Zhengzhou, Henan

  • Affiliated Hospital Ofzunyi Medical University

    Zunyi, Guizhou

Other trials in China

About this study

Official title: Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial

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.

Being tested
Bivalirudin, unfractionated Heparin
Keywords
Primary percutaneous coronary intervention, anticoagulant agents, bivalirudin, heparin
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BivalirudinDrug

    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.

  • unfractionated HeparinDrug

    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.

Study groups in NCT03822975
Study groupRoleWhat they receive
BivalirudinExperimentalBivalirudin with prolonged full dose infusion during primary PCI
Receives: Drug: Bivalirudin
HeparinActive comparatorHeparin alone during primary PCI
Receives: Drug: unfractionated Heparin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of all-cause death or BARC type 3~5 bleeding

    BARC=Bleeding academic research consortium

    Measured: 30 days

Secondary outcomes (9)

  1. All cause mortality

    Measured: 30 days

  2. BARC type 3-5 bleeding

    BARC=Bleeding academic research consortium

    Measured: 30 days

  3. 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

    Measured: 30 days

  4. Net adverse clinical events (NACE)

    NACE is defined as a composite of MACE or BARC type 3-5 bleeding

    Measured: 30 days

  5. Composite of all-cause death or BARC type 2-5 bleeding

    BARC=Bleeding academic research consortium

    Measured: 30 days

  6. BARC type 2-5 bleeding

    BARC=Bleeding academic research consortium

    Measured: 30 days

  7. Stent thrombosis

    Definite or probable stent thrombosis according to Academic Research Consortium

    Measured: 30 days

  8. Thrombocytopenia

    defined as platelet counts less than 150*10^9/L after treatment

    Measured: 30 days

  9. All cause mortality

    Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start14 Feb 2019
  3. Primary completion7 May 2022
  4. Study completion6 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
6,016 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03822975
Sponsor's protocol ID
2018-031
Acronym
BRIGHT-4
Status last verified
Aug 2025
First submitted
29 Jan 2019
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36351459

  • Liang Z, Qin L, Wang M, Wang X, Zhang H, Liu Y, Li Y, Liu L, Luo J, Dong S, Guo J, Zhu H, Li S, Zheng H, Liu L, Wu Y, Zhong Y, Qiu M, Li Y, Han Y, Stone GW. Bivalirudin With a High-Dose Post-PCI Infusion Versus Heparin During Primary PCI in STEMI: One-Year Results From the BRIGHT-4 Trial. Circ Cardiovasc Interv. 2026 Oct 31:e017029. doi: 10.1161/CIRCINTERVENTIONS.126.017029. Online ahead of print.

    PubMed 42965935

  • Qiu M, Duan Y, Feng X, Chen K, Zhang D, Zou Y, Zheng X, Zhao G, Tian N, Zheng Z, Peng X, Yang Q, Liang Z, Li Y, Han Y, Stone GW. Bivalirudin Versus Heparin in Low and Non-Low Bleeding Risk Patients Undergoing Primary PCI for STEMI: The BRIGHT-4 Trial. J Am Coll Cardiol. 2026 Jul 27:S0735-1097(26)06997-4. doi: 10.1016/j.jacc.2026.06.035. Online ahead of print.

    PubMed 42663356

  • Zhang D, Li Y, Qiu M, Liang Z, Xu K, Li Y, Zhang G, Xie W, Zeng H, Cheng Y, Liu J, Cheng X, Zeng Q, Zhu K, Hu J, Cheng K, Wang J, Cheng R, Zhou Y, Wang B, Cao G, Han Y, Stone GW. BMI differences on anticoagulation with bivalirudin vs. heparin during primary PCI: a BRIGHT-4 subanalysis. BMC Med. 2025 Sep 30;23(1):525. doi: 10.1186/s12916-025-04374-7.

    PubMed 41029353

  • Su X, Qiu M, Gu C, Yang X, Liu B, Meng F, Ning B, Li W, Zhong Z, Wang Z, Shi B, Shang Z, Liang Z, Li Y, Han Y, Stone GW. Analysis of inter-hospital transfer on clinical outcomes after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: A secondary analysis of the BRIGHT-4 trial. PLoS Med. 2025 Jul 23;22(7):e1004679. doi: 10.1371/journal.pmed.1004679. eCollection 2025 Jul.

    PubMed 40700454

  • Liao J, Qiu M, Feng X, Chen K, Zhang D, Zou Y, Zheng X, Zhao G, Tian N, Zheng Z, Peng X, Yang Q, Liang Z, Li Y, Han Y, Stone GW. Bivalirudin versus heparin in patients with or without bail-out GPI use: a pre-specified subgroup analysis from the BRIGHT-4 trial. BMC Med. 2024 Sep 27;22(1):410. doi: 10.1186/s12916-024-03579-6.

    PubMed 39334129

Questions about this trial

What is this clinical trial studying?

A study testing Bivalirudin and unfractionated Heparin in people with ST Elevation Myocardial Infarction, run by Shenyang Northern Hospital at 85 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of all-cause death or BARC type 3~5 bleeding (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03822975, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in