Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this 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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Bivalirudin
  • Unfractionated heparin

Treatment groups

2,400 Participants
are divided into 2 treatment groups

Locations

This trial has no locations