Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open label, cohort study, in which a total of 100 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during short-term intervention of non-infarction related artery for acute ST-segment elevation myocardial infarction after emergency percutaneous coronary intervention.

NACE, MACE, any type of BARC bleeding, stent thrombosis will be evaluated in 30 days and 6 months after recruitment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Hanzhong Central Hospital; Shaanxi Provincial People's Hospital; Xiangyang Central Hospital; Xianyang Central Hospital; Yan'an University Affiliated Hospital
• Treatments: Bivalirudin; Heparin

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• Acute STEMI (including patients within 12 h of symptom onset, or 24-48 h with recurrent or ongoing chest pain chest pain, persistent ST-segment elevation or new left bundle branch block.

• Staged intervention of non-infarction related artery within 5 days after PPCI during Hospitalization.

• Signed informed consent.

Exclusion Criteria:

• Cardiogenic shock.

• Received thrombolytic therapy or used any anticoagulant drugs within 48 hours before randomized.

• Active bleeding, recent bleeding events or bleeding tendency.

• History of surgery in the last 1 month.

• Suspicious symptoms of aortic dissection, pericarditis and endocarditis.

• Blood pressure > 180/110 mmHg.

• Hemoglobin < 100 g/L, Platelet count <100×10(9)/L, Transaminase 3 times upper limit of normality or Creatinine clearance <30ml/min.

• History of Heparin-Induced Thrombocytopenia.

• Allergic to any research drug or device.

• Pregnancy or lactation.

• Any condition that makes the patient unsuitable for PCI or may interfere with the study.

• Patient disagrees or fails to sign the written informed consent.