NCT04475835

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

Study on Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery for Acute ST-segment Elevation Myocardial Infarction After Emergency Percutaneous Coronary Intervention

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The 2017 guideline gives a class IIA recommendation ('should be considered') for complete revascularisation in patients presenting with STEMI and multivessel disease, which is approximately 50% of the STEMI population. Staged multivessel PCI during hospitalization (3-5 days after PPCI) is common in contemporary practice. Patients undergoing primary PCI should receive enhanced antithrombotic therapy, includes DAPT and and parenteral anticoagulant, which caused an increased bleeding risk. In addition, repeated use of heparin in a short time may increase the incidence of HIT. Direct thrombin inhibitor bivalirudin, demonstrated a reduced risk of bleeding and an overall favorable profile including reduced NACE. This is a randomized, open label, cohort study, which is aimed to investigate the safety and efficacy of bivalirudin during short-term intervention of non-infarction related artery for acute ST-segment elevation myocardial infarction after emergency percutaneous coronary intervention.

Conditions

• STEMI With Multivessel Coronary Disease

Interventions

Type	Name	Description
DRUG	Bivalirudin	Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 4 hours after PCI. A prolonged infusion of 0.2 mg/kg/h for ≤20h could be considered at the operator's discretion. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is \<225 s (Hemotec method), intravenous injection of 0.30 mg/kg of bivalirudin should be administered.
DRUG	Heparin	Heparin is dosed at 100 U/kg. ACT is monitored 5 min after the first administration, and if the ACT \<225 s (Hemotec method), an intravenous injection of heparin should be administered by need.

Timeline

• Start date: 2021-01-12
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-07-17
• Last updated: 2022-05-02

Locations

1 site across 1 country: China