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

August 20, 2025 updated by: Han Yaling, Shenyang Northern Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6016

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bivalirudin
Bivalirudin with prolonged full dose infusion during primary PCI
Drug: Bivalirudin
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.
Active Comparator: Heparin
Heparin alone during primary PCI
Drug: unfractionated Heparin
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite of all-cause death or BARC type 3~5 bleeding
Time Frame: 30 days
BARC=Bleeding academic research consortium
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 30 days
30 days
BARC type 3-5 bleeding
Time Frame: 30 days
BARC=Bleeding academic research consortium
30 days
Major adverse cardiac and cerebral events (MACE)
Time Frame: 30 days
MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization
30 days
Net adverse clinical events (NACE)
Time Frame: 30 days
NACE is defined as a composite of MACE or BARC type 3-5 bleeding
30 days
Composite of all-cause death or BARC type 2-5 bleeding
Time Frame: 30 days
BARC=Bleeding academic research consortium
30 days
BARC type 2-5 bleeding
Time Frame: 30 days
BARC=Bleeding academic research consortium
30 days
Stent thrombosis
Time Frame: 30 days
Definite or probable stent thrombosis according to Academic Research Consortium
30 days
Thrombocytopenia
Time Frame: 30 days
defined as platelet counts less than 150*10^9/L after treatment
30 days
All cause mortality
Time Frame: 1 years
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenyang Northern Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yaling Han, MD, The General Hospital of Northern Theater Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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