Clinical trial NCT06861374: Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Keywords: STEMI, PCI, fibrinolysis, bivalirudin, heparin, bleeding, mortality
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 2400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Composite of all-cause death or BARC type 3、5 bleeding
timeFrame: 30days
Secondary outcomes:
measure: All cause mortality
timeFrame: 30days and 1year
measure: Composite of all-cause death or BARC type 2、3、5 bleeding
timeFrame: 30days and 1year
measure: Net adverse clinical events (NACE)
timeFrame: 30days and 1year
measure: Major adverse cardiac and cerebral events (MACCE)
timeFrame: 30days and 1year
measure: Stent thrombosis
timeFrame: 30days
measure: BARC type 3、5 bleeding
timeFrame: 30days
measure: BARC type 2、3、5 bleeding
timeFrame: 30days
measure: Thrombocytopenia
timeFrame: 30days
Other outcomes:
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