Current partner codePEPTIDESDE
NCT06861374·Not applicable·INTERVENTIONAL

Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy

Status

Not yet recruiting

Phase

Not applicable

Enrollment

2,400

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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 180s\<ACT\<225s, bivalirudin 0.5mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI; (3) if ACT\>225s, 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.

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 180\<ACT\<225s, administer an intravenous bolus of unfractionated heparin at 60 U/kg before coronary angiography, with a maximum total dose of 4000U. (3)If ACT\>225s, proceed directly with PCI and maintain 225s\<ACT\<350s.

Timeline

From registration to results.

  1. First posted

    Mar 6, 2025

  2. Study start

    May 2025

  3. Primary completion

    Mar 2028

  4. Study completion

    Mar 2029

  5. Results posted

    Not reported

  6. Registry updated

    Mar 6, 2025

Outcomes

What the study measures.

Primary outcomes

Composite of all-cause death or BARC type 3、5 bleeding

Time frame · 30days

BARC=Bleeding academic research consortium

Secondary outcomes

All cause mortality

Time frame · 30days and 1year

Composite of all-cause death or BARC type 2、3、5 bleeding

Time frame · 30days and 1year

BARC=Bleeding academic research consortium

Net adverse clinical events (NACE)

Time frame · 30days and 1year

NACE is defined as a composite of MACCE or BARC type 3、5 bleeding

Major adverse cardiac and cerebral events (MACCE)

Time frame · 30days and 1year

MACCE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization

Stent thrombosis

Time frame · 30days

Definite or probable stent thrombosis according to Academic Research Consortium

BARC type 3、5 bleeding

Time frame · 30days

BARC=Bleeding academic research consortium

BARC type 2、3、5 bleeding

Time frame · 30days

BARC=Bleeding academic research consortium

Thrombocytopenia

Time frame · 30days

defined as platelet counts less than 150\*10\^9/L after treatment

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.