Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes

NCT07383155 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: BRIGHT-HBR2025ZD0546400
• Study Type: interventional
• Target: 5,270
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background. Randomized data on the optimal parenteral anticoagulant during percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with acute coronary syndromes (ACS) are lacking. Methods. BRIGHT-HBR is an investigator-sponsored, open-label, randomized controlled trial comparing bivalirudin vs. unfractionated heparin (UFH) monotherapy in HBR patients with ACS undergoing PCI. A total of 5270 HBR patients with a non-ST-elevation acute coronary syndrome (NSTE-ACS) or recent stabilized ST-segment elevation myocardial infarction (STEMI, ≥48 hours after symptom onset) will be randomized 1:1 to bivalirudin or UFH at 70 sites in China. HBR is defined by the Academic Research Consortium (ARC)-HBR criteria. The primary composite endpoint is net adverse clinical events (NACE) at 30 days, the composite of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, or BARC types 2, 3 or 5 bleeding, and the major secondary endpoint is BARC types 2, 3 or 5 bleeding. The study is powered to demonstrate that bivalirudin is superior to UFH monotherapy for NACE in ACS patients with HRB at 30 days after PCI. Conclusions. The BRIGHT-HBR randomized trial aims to provide evidence on whether bivalirudin reduces the incidence of NACE and clinically relevant bleeding compared with UFH monotherapy in patients with ACS who are at HBR undergoing PCI.

Conditions

Percutaneous Coronary Intervention; High Bleeding Risk; Acute Coronary Syndromes; Anticoagulant Therapy

Outcome Measures

Primary Outcomes (1)

• Net adverse clinical events (NACE) at 30 days

  The composite of all-cause death, MI, stroke, urgent target-vessel revascularization, or BARC types 2, 3 or 5 bleeding

  30 days post PCI

Secondary Outcomes (7)

• BARC types 2, 3 or 5 bleeding at 30 days

  30 days post PCI

• NACE at 12 months

  1 year post PCI

• Each individual component of NACE at 30 days and 12 months

  30 days and 1 year post PCI

• Major adverse cardiac and cerebral events (MACCE) at 30 days and 12 months

  30 days and 1 year post PCI

• BARC types 1, 2, 3, or 5 bleeding at 30 days and 12 months

  30 days and 1 year post PCI

Study Arms (2)

Group 1

EXPERIMENTAL

Bivalirudin

Drug: Anticoagulant Therapy

Group 2

ACTIVE COMPARATOR

Unfractionated heparin monotherapy

Drug: Anticoagulant Therapy

Interventions

Anticoagulant Therapy DRUG

The optimal parenteral anticoagulant during percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with acute coronary syndromes (ACS)

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Clinical evidence of NSTE-ACS or recent stabilized STEMI (≥48 hours after symptom onset) undergoing PCI
• The patient meets the ARC criteria for HBR (≥1 major criterion or ≥2 minor criteria)
• The patient or legal representative has been fully informed and written informed consent has been obtained

You may not qualify if:

• STEMI patients within 48 hours of symptom onset
• CABG or PCI within the prior 6 months, including for the present clinical syndrome
• Cardiogenic shock
• Coronary artery disease unsuitable for revascularization or requiring CABG
• Confirmed or suspected aortic dissection
• Treatment with a glycoprotein IIb/IIIa inhibitor within 2 hours prior to the PCI (use of intravenous heparin prior to or at the time of randomization is acceptable)
• Allergy to UFH, bivalirudin, aspirin, clopidogrel, ticagrelor, or contrast agents that cannot be adequately pre-medicated, or any prior anaphylaxis to these agents
• Any non-cardiac conditions with an expected life expectancy of ≤12 months
• Patients deemed by the investigator to be clinically unsuitable for coronary angiography and PCI, or who are unlikely to be able to comply with the protocol requirements, including medication adherence and follow-up visits

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Yaling Han, MD

CONTACT

86-24-28897310; hanyaling@263.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01