Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy (BRIGHT-FIT)

Bivalirudin Plus High-Dose Infusion Versus Heparin Monotherapy in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention After Fibrinolysis: a Randomized Trial

This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis. Participants will be randomly assigned in a 1:1 ratio to receive either bivalirudin or heparin, with follow-up at 30 days and 1 year. The primary endpoint is a composite of all-cause mortality and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 30 days.

Study Overview

• Status: Not yet recruiting
• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
• Intervention / Treatment: Drug: Bivalirudin; Drug: Unfractionated heparin

Detailed Description

Bivalirudin is a direct thrombin inhibitor that exhibits a reversible and transient anticoagulant effect. Randomized trials have shown conflicting results for bivalirudin in reducing the risk of bleeding for ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI (PPCI) compared to heparin. Recently, the BRIGHT-4 study, which assigned 6016 STEMI patients to bivalirudin with a prolonged high dose infusion or heparin during PPCI, showed bivalirudin decreased the risk of a composite endpoint of all-cause mortality and bleeding. However, few studies have focused on the safety and efficacy of bivalirudin in PCI post-fibrinolysis. We therefore aim to conduct the Bivalirudin With Prolonged Infusion During PCI Versus Heparin Following Fibrinolytic Therapy (BRIGHT-FIT) trial to examine whether bivalirudin with a high-dose infusion in PCI after fibrinolysis in superior to heparin in reducing mortality and major bleeding.

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Chen, MD; Phone Number: (86)13891995622; Email: chentao0331@xjtu.edu.cn
• Study Contact Backup: Name: Chenbo Xu, MD; Phone Number: (86)13468763406; Email: xuchenbox@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any age
• STEMI patients received fibrinolysis therapy within 12h of symptom onset and are planned to undergo PCI within 24h of symptom onset.
• Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor)
• 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);
• 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 PCI;
• Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);
• Cardiogenic shock(Killip IV)
• Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor
• Patients who underwent PCI in past 30 days
• 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, pregnancy).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bivalirudin; bivalirudin with a prolonged infusion	Drug: Bivalirudin; For rescued PCI, do not recommend to include patient who's ACT is more than 350s. If fibrinolysis is successful, monitor ACT and wait till it's lower than 350s before randomization. Monitor ACT before angiography, (1) if ACT<180, bivalirudin 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; (2) if 180s225s, bivalirudin intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI. (4) ACT be monitored 5 minutes after the first administration, and if ACT is <225 s, intravenous injection of 0.3 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is >225 seconds.
Active Comparator: Heparin; Heparin alone during PCI	Drug: Unfractionated heparin; (1)If ACT<180s, administer an intravenous bolus of unfractionated heparin at 70 U/kg before coronary angiography, with a maximum total dose of 6000U. (2)If 180225s, proceed directly with PCI and maintain 225s

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of all-cause death or BARC type 3、5 bleeding	BARC=Bleeding academic research consortium	30days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality		30days and 1year
Composite of all-cause death or BARC type 2、3、5 bleeding	BARC=Bleeding academic research consortium	30days and 1year
Net adverse clinical events (NACE)	NACE is defined as a composite of MACCE or BARC type 3、5 bleeding	30days and 1year
Major adverse cardiac and cerebral events (MACCE)	MACCE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization	30days and 1year
Stent thrombosis	Definite or probable stent thrombosis according to Academic Research Consortium	30days
BARC type 3、5 bleeding	BARC=Bleeding academic research consortium	30days
BARC type 2、3、5 bleeding	BARC=Bleeding academic research consortium	30days
Thrombocytopenia	defined as platelet counts less than 150*10^9/L after treatment	30days

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: STEMI, PCI, fibrinolysis, bivalirudin, heparin, bleeding, mortality
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; ST Elevation Myocardial Infarction; Myocardial Infarction; Infarction; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; Antithrombins; Serine Proteinase Inhibitors; Heparin; Calcium heparin; Bivalirudin
• Other Study ID Numbers: XJTU1AF2024LSYY-321

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