Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes (NCT07383155) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes
5,270 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.