Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy

Launched by FIRST AFFILIATED HOSPITAL XI'AN JIAOTONG UNIVERSITY · Mar 3, 2025

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ClinConnect Summary

This clinical trial is studying two different blood-thinning medications, bivalirudin and heparin, to see which one is more effective and safer for patients who have had a heart attack known as STEMI and are undergoing a procedure called percutaneous coronary intervention (PCI). This trial will include about 2,400 patients in China who received a treatment called fibrinolysis (which helps dissolve blood clots) and will have PCI within 24 hours of their heart attack. Participants will be randomly assigned to receive either bivalirudin or heparin, and their health will be monitored for 30 days and again after one year to see if either medication leads to fewer complications, such as death or serious bleeding.

To be eligible for this trial, patients must be any age and have received fibrinolysis within 12 hours of their heart attack symptoms. They also need to be scheduled for PCI within 24 hours and must take specific medications to prevent blood clots before the procedure. Some patients may be enrolled even if they need additional procedures later on, as long as they are treated consistently. However, those who cannot safely undergo PCI, have certain serious complications, or have allergies to the medications involved will not be included. Participants can expect to help researchers understand which medication might be better for future patients, while also receiving careful medical attention throughout the study.

Gender

ALL

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).