Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy

NCT06861374 | Not Yet Recruiting DMC

• 1 other identifier: XJTU1AF2024LSYY-321
• Study Type: interventional
• Target: 2,400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

STEMI, PCI, fibrinolysis, bivalirudin, heparin, bleeding, mortality

Outcome Measures

Primary Outcomes (1)

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

  BARC=Bleeding academic research consortium

  30days

Secondary Outcomes (8)

• All cause mortality

  30days and 1year

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

  30days and 1year

• Net adverse clinical events (NACE)

  30days and 1year

• Major adverse cardiac and cerebral events (MACCE)

  30days and 1year

• Stent thrombosis

  30days

Study Arms (2)

Bivalirudin

EXPERIMENTAL

bivalirudin with a prolonged infusion

Drug: Bivalirudin

Heparin

ACTIVE COMPARATOR

Heparin alone during PCI

Drug: Unfractionated heparin

Interventions

Bivalirudin DRUG

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.

Bivalirudin

Unfractionated heparin DRUG

(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.

Heparin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Hemorrhage

Interventions

bivalirudin; Heparin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Tao Chen, MD

CONTACT

(86)13891995622; chentao0331@xjtu.edu.cn

Chenbo Xu, MD

CONTACT

(86)13468763406; xuchenbox@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 6, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share